Regulating Hype and Hope: A Business Ethics - Crowell & Moring

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REGULATING HYPE AND HOPE: A BUSINESS ETHICS MODEL APPROACH TO POTENTIAL OVERSIGHT OF DIRECT-TO- CONSUMER GENETIC TESTS Matthew Piehl INTRODUCTION ......................................................................................................... 59 I. EXISTING REGULATIONS .................................................................................... 66 A. Food and Drug Administration ................................................................ 66 B. Clinical Laboratory Improvement Amendments ................................... 74 C. Federal Trade Commission ....................................................................... 76 II. THE CASE FOR REGULATION, MORE OR LESS .............................................. 77 A. Informed Consent....................................................................................... 83 B. Quality Assurance ....................................................................................... 89 III. A PLAN TO REGULATE DIRECT-TO-CONSUMER GENETIC TESTS.......... 91 IV. CONCLUSION...................................................................................................... 93 INTRODUCTION We are at the beginning of a personal-genomics revolution that will transform not only how we take care of ourselves but also what we mean by personal information. In the past, only elite researchers had access to their genetic fingerprints, but now personal genotyping is available to anyone who orders the service online and mails in a spit sample. 1 With this bold statement, TIME magazine introduced its Invention of the Year in 2008the Retail DNA Test,more commonly referred to as the direct-to-consumer (DTC) genetic test. Genetic tests analyze human deoxy- ribonucleic acid (DNA), ribonucleic acid (RNA), chromosomes, proteins, or metabolites in order to detect and diagnose disease, identify future health risks, predict drug responses, or discover ancestral relationships. 2 DTC genetic test companies sell genetic testing services straight to an individual who re- quested the test and can receive the results without the involvement of the Associate, Crowell & Moring LLP; J.D., 2011, University of Virginia School of Law; B.S. Biology, 2008, Duke University. I would like to thank Professor Gil Siegal for his guidance and feedback on many drafts of this Article. I am also indebted to my family for their support in all of my endeavors. 1. Anita Hamilton, Best Inventions of 2008: The Retail DNA Test, TIME (Oct. 29, 2008), http://www.time.com/time/specials/packages/article/0,28804,1852747_1854493,00.html. 2. See Wylie Burke, Genetic Testing, 347 NEW ENG. J. MED. 1867 (2002), available at http://www.nejm.org/doi/pdf/10.1056/NEJMoa012113.

Transcript of Regulating Hype and Hope: A Business Ethics - Crowell & Moring

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REGULATING HYPE AND HOPE: A BUSINESS ETHICS MODEL

APPROACH TO POTENTIAL OVERSIGHT OF DIRECT-TO-CONSUMER GENETIC TESTS

Matthew Piehl

INTRODUCTION ......................................................................................................... 59 I. EXISTING REGULATIONS .................................................................................... 66

A. Food and Drug Administration ................................................................ 66 B. Clinical Laboratory Improvement Amendments ................................... 74 C. Federal Trade Commission ....................................................................... 76

II. THE CASE FOR REGULATION, MORE OR LESS .............................................. 77 A. Informed Consent ....................................................................................... 83 B. Quality Assurance ....................................................................................... 89

III. A PLAN TO REGULATE DIRECT-TO-CONSUMER GENETIC TESTS .......... 91 IV. CONCLUSION ...................................................................................................... 93

INTRODUCTION

We are at the beginning of a personal-genomics revolution that will transform not only how we take care of ourselves but also what we mean by personal information. In the past, only elite researchers had access to their genetic fingerprints, but now personal genotyping is available to anyone who orders the service online and mails in a spit sample.1

With this bold statement, TIME magazine introduced its Invention of

the Year in 2008—the “Retail DNA Test,” more commonly referred to as the direct-to-consumer (“DTC”) genetic test. Genetic tests analyze human deoxy-ribonucleic acid (“DNA”), ribonucleic acid (“RNA”), chromosomes, proteins, or metabolites in order to detect and diagnose disease, identify future health risks, predict drug responses, or discover ancestral relationships.2 DTC genetic test companies sell genetic testing services straight to an individual who re-quested the test and can receive the results without the involvement of the

Associate, Crowell & Moring LLP; J.D., 2011, University of Virginia School of Law; B.S. Biology, 2008, Duke University. I would like to thank Professor Gil Siegal for his guidance and feedback on many drafts of this Article. I am also indebted to my family for their support in all of my endeavors. 1. Anita Hamilton, Best Inventions of 2008: The Retail DNA Test, TIME (Oct. 29, 2008), http://www.time.com/time/specials/packages/article/0,28804,1852747_1854493,00.html. 2. See Wylie Burke, Genetic Testing, 347 NEW ENG. J. MED. 1867 (2002), available at http://www.nejm.org/doi/pdf/10.1056/NEJMoa012113.

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individual’s healthcare provider.3 As outlined in Table 1 below for four sample companies,4 consumers typically purchase DTC genetic tests over the internet and receive a kit by mail. The consumer then provides a sample—such as a cheek swab or saliva—and ships the kit back to the laboratory for analysis. The laboratory then analyzes the genetic sample and delivers the results to the consumer via mail or a secured website. No company requires the involve-ment of a physician or genetic counselor, and the consumer does not have to report the results to his healthcare provider or insurance company.

Table 1: Selected Direct-to-Consumer Testing Companies

Company Price Tests Offered DTC Model

Counseling

23andMe5 $399 for a prepaid test kit or $99 plus $9 per month for at least one year for “personal genome ser-vice,” which includes monthly up-dates on information about the client’s DNA, discounts on future tech-nologies, and sample stor-age.

Two tests included: 1) ancestry; and 2) susceptibility to common diseases and drug reactions.

Consumer sends a sali-va sample to a lab and receives a report online.

Offers counseling through Informed DNA for an additional charge ($35–$375).

3. Stuart Hogarth, Gail Javitt & David Melzer, The Current Landscape for Direct-to-Consumer Genetic Testing: Legal, Ethical, and Policy Issues, 9 ANN. REV. GENOMICS & HUM. GENETICS 161, 163-64 (2008) (DTC genetic tests also refers to tests that are advertised to the public but must be ordered by, and results are delivered to, a healthcare provider). 4. These four companies were chosen because they were the companies investigated by the Government Accountability Office (“GAO”) in 2006. See infra notes 29-40 and accompany-ing text. 5. 23ANDME, https://www.23andme.com/ (last visited Sept. 7, 2011).

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Navigenics6 Approximate-ly $1000 though dis-counts are available if chosen through an employer wellness pro-gram.

Screens for genetic markers for 28 common conditions, such as Alz-heimer’s and glaucoma. Checks for possible medi-cation respons-es.

Consumer must order through a physician or employer plan. Con-sumer sends a saliva sam-ple to a lab and receives a report online.

Kit includes phone counseling with trained genetic counselors. Company will “help locate” counselors for in-person ses-sions.

Pathway Genomics7

The Walgreen’s kits would have cost between $99 and $279 total.8 The actual cost of ob-taining the kit through a physician is unknown.

Comprehensive genotyping is available. The consumer can select small reports that display propen-sities for select-ed conditions.

Consumer orders a kit through the physician. A saliva sample is sent to the lab. Results are returned to the physi-cian. Plans to sell the kits through Walgreen’s are on hold.

Consumers may e-mail a genetic counselor on the web-site.

6. NAVIGENICS, http://www.navigenics.com/ (last visited Sept. 7, 2011). 7. PATHWAY GENOMICS, http://www.pathway.com/ (last visited Sept. 7, 2011). 8. Madison Park, Walgreens Postpones Plans to Sell Personal Genetic Tests, CNN (May 12, 2010), http://articles.cnn.com/2010-05-12/health/genetic.testing.walgreens_1_genetic-disorders-walgreens-kits?_s=PM:HEALTH.

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deCODE Genetics9 (Iceland)

$1100–2000 for the com-plete genome scan and as-sociated ser-vices; $500 for special-ized scans, such as the deCODEme Cancer scan.

A variety of tests offered that focus on specific diseas-es, such as breast cancer, or a “complete scan” that ana-lyzes genetic risk factors for 478 diseases” conditions and traits.” Ances-try test also available. deCODE also offers specific diagnostic tests for use by med-ical profession-als.

Consumer orders a kit online, sends a sample to a lab, and receives a report online.

Offers free genetic counseling through a network of counselors.

The Food and Drug Administration estimates that several hundred la-

boratories offer between 2500 and 5000 different DTC genetic tests.10 To begin, most companies typically offered nutrigenetic tests—tests that assess what kinds of foods individuals should eat and which dietary supplements they should take.11 At present, as Table 1 shows, three other types of genetic tests dominate the market.12

First, DTC genetic test companies offer ancestry tests that report on fa-milial relationships between individuals. For example, 23andMe’s service in-cludes an ancestry portion that presents three sub-tests: (1) the Relative Finder allows the consumer to locate other 23andMe users who match their familial DNA profile; (2) the Global Origins test locates the historical homes of the consumer’s ancestors; and (3) the Ancestral Lineages test promises to track

9. DECODE GENETICS, http://www.decode.com/ (last visited Sept. 7, 2011). 10. Direct-to-Consumer Genetic Testing and the Consequences to the Public Health: Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 111th Cong. 7 (2010) (statement of Jeffrey Shuren, Director, Center for Devices and Radiological Health, Food and Drug Administration, Department of Health and Human Services) [hereinafter State-ment of Jeffrey Shuren]. 11. Id. at 9. 12. Rebecca Antar Novick, One Step at a Time: Ethical Barriers to Home Genetic Testing and Why the U.S. Health Care System is Not Ready, 11 N.Y.U. J. LEGIS. & PUB. POL’Y 621, 631 (2008).

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the ancient migrations of the consumer’s ancestors.13 Second, predictive ge-netic information and diagnostic testing identifies carrier status of genetic diseases and detects or confirms a condition present in an affected individu-al.14 The health portion of the test offered by 23andMe, for instance, includes these tests.15 Third, pharmacogenetic testing identifies genetic variations that predict an individual’s response to drug treatments.16 Pharmacogenetic testing purports to analyze the efficacy and safety of various drug therapies for the individual.17 For example, The Drug Response sub-test of the Health Edition from 23andMe promises to provide an advance report of how the consumer will respond to certain medications.18

It is the extraordinary promise of DTC genetic tests that led to TIME hailing them as the Invention of the Year.19 DTC genetic tests can educate individuals about their unique health risks and the steps they can take to miti-gate those risks.20 The tests can lead to improved therapies by identifying ge-netic variability in patient response to treatments and targeting the molecular causes of some diseases.21 They can increase accuracy of diagnosis and guide selection of treatment options for various diseases.22 “Genetic tests can also be used to determine genetic contributions to the risk of common diseases, in order to guide preventative care.”23

However, it is the fear of what DTC genetic testing can lead to that has many experts pushing for tighter regulation of the industry.24 Current federal regulation of DTC genetic tests in the United States is lacking,25 leading to concerns over the multitude of issues presented by the nearly unfettered ac-cess to a barely-regulated industry. Proponents of increased regulation point

13. Ancestry, 23ANDME, https://www.23andme.com/ancestry/ (last visited Sept. 7, 2011). 14. Novick, supra note 12, at 633; Gail H. Javitt, Erica Stanley & Kathy Hudson, Direct-to-Consumer Genetic Tests, Government Oversight, and the First Amendment: What the Government Can (and Can’t) Do to Protect the Public’s Health, 57 OKLA. L. REV. 251, 259 (2004). 15. See generally Health, 23ANDME, https://www.23andme.com/health/ (last visited Sept. 7, 2011). 16. Javitt et al., supra note 14, at 260. 17. Novick, supra note 12, at 632. 18. See Health supra note 15. 19. Anita Hamilton, Best Inventions of 2008: The Retail DNA Test, TIME (Oct. 29, 2008), http://www.time.com/time/specials/packages/article/0,28804,1852747_1854493,00.html. 20. Hogarth et al., supra note 3, at 168. 21. Margaret A. Hamburg & Francis S. Collins, The Path to Personalized Medicine, 363 NEW

ENG. J. MED. 301 (2010), available at http://www.nejm.org/doi/pdf/10.1056/NEJMp1006304. 22. Denise Caruso, Genetic Tests Offer Promise, But Raise Questions, Too, N.Y. TIMES (Feb. 18, 2007), http://www.nytimes.com/2007/02/18/business/yourmoney/18reframe.html? pagewanted=1. 23. Burke, supra note 2, at 1872. 24. See, e.g., David Magnus, Mildred K. Cho & Robert Cook-Deegan, Direct-to-Consumer Genetic Tests: Beyond Medical Regulation?, 1 GENOME MED. 17 (2009); see also Bruce Patsner, New “Home Brew” Predictive Genetic Tests Present Significant Regulatory Problems, 9 HOUS. J. HEALTH L. &

POL’Y 237 (2009). 25. Patsner, supra note 24, at 239.

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to insufficient quality assurance and test validity produced by a lack of gov-ernment oversight.26 Furthermore, genetic tests may only report a probability for developing a disorder, presenting a difficulty in interpreting a positive re-sult since some people who carry a mutation never actually develop the dis-ease.27 The problem of interpretation may be exacerbated by the lack of pro-fessional intervention—either by physicians or genetic counselors—currently required.28 Without a physician or genetic counselor to assist, the consumer could easily misinterpret the results of a genetic test and undergo unnecessary treatment.29

Both fears that consumers could be misled by results and by the DTC genetic test companies were heightened further after two Government Ac-countability Office (“GAO”) investigations of DTC genetic tests. In the first “sting,” the GAO purchased nutrigenetic tests from four unnamed DTC ge-netic test companies.30 The GAO posed as fourteen individual consumers by sending in fourteen DNA samples; twelve of those samples, though, came from a single nine-month-old female while the other two samples came from one unrelated forty-eight-year-old male.31 The results proved ambiguous and generic. For example, one company warned that the nine-month-old displayed a “significant risk of developing the age related conditions associated with elevated levels of DNA damage.”32 Another company reported that both the female and the male, despite having different DNA variants, were at an in-creased risk for osteoporosis, high blood pressure, type 2 diabetes, and heart disease.33 According to experts, these results were so ambiguous as to be meaningless and could apply to any human who submitted DNA.34 The results from one company recommended that both the female and the male purchase “personalized, custom” nutritional supplements from the company for ap-

26. Sivan Tamir, Direct-to-Consumer Genetic Testing: Ethical-Legal Perspectives and Practical Con-siderations, 18 MED. L. REV. 213, 214 (2010). For a more in-depth discussion of this problem, see infra Part II Section B. 27. U.S. Dep’t of Genome Energy Programs, Gene Testing, HUMAN GENOME PROJECT, http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetest.shtml (last modified Sept. 17, 2010). 28. Tamir, supra note 26, at 214. For a more in-depth discussion of this problem, see infra Part II Section A. 29. Lauren B. Solberg, Note, Over the Counter but Under the Radar: Direct-to-Consumer Genetic Tests and FDA Regulation of Medical Devices, 11 VAND. J. ENT. & TECH. L. 711, 721 (2009); see also infra Part II Section C. 30. Nutrigenetic Testing: Tests Purchased from Four Web Sites Mislead Consumers: Hearing Before the S. Spec. Comm. on Aging, 109th Cong. 2 (2006) (statement of Gregory Kutz, Managing Director, Forensic Audits and Special Investigations, Government Accountability Office) [hereinafter Nutrigenetic Testing]. 31. Id. at 2-3. 32. Id. at 12 (internal citations omitted). 33. Id. at 9 (Figure 3). 34. Id. at 14.

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proximately $1200 per year.35 The ingredients for these “personalized, cus-tom” supplements, however, proved to be identical for the female and the male consumer. Furthermore, analysis of the supplements showed that they contain common vitamins that could be purchased at most grocery stores for around $35 per year.36

A follow-up study by the GAO in 2010 purchased diagnostic tests from the four companies listed in Table 1—23andMe, Navigenics, Pathway Ge-nomics, and deCODE Genetics.37 For this investigation, GAO used five indi-viduals and submitted two samples for each person—one using factual infor-mation and the other using fictional. For example, one donor had her samples submitted as her factual self—a thirty-seven-year-old Caucasian—and as her fictional self—a sixty-eight-year-old African-American.38 As in the 2006 study, the GAO received misleading and meaningless results from the DTC genetic test companies. For instance, donor one received three different risk predic-tions for leukemia from three companies—above average, below average, and average (the fourth did not test for this condition).39 Donors also received disease predictions that conflicted with their actual medical conditions; for example, a company told one donor who had a pacemaker implanted thirteen years ago to treat an irregular heartbeat that he was at a decreased risk for developing atrial fibrillation.40 Two companies asserted they could predict which sports children would excel at based on DNA analysis, a claim charac-terized as “complete garbage” by an expert utilized by the GAO.41

The results of the GAO investigations and the various fears discussed above indicate that some government oversight may be necessary in this bur-geoning biotechnology field. This Article will use a business ethics model to discuss whether increased regulation is necessary or whether DTC genetic companies can police themselves under common business ethics principles. Part I will discuss existing regulations in the United States over DTC genetic tests. Part II will then utilize the business ethics model to discuss whether increased regulation is necessary. Part III will conclude the Article by explor-ing one option for expanded oversight, if necessary.

35. Id. at 14. 36. Nutrigenetic Testing, supra note 30, at 15. 37. Jennifer Corbett Dooren & Anna Wilde Mathews, DNA-Test Results Mislead Consumers, Investigators Say, WALL ST. J., July 23, 2010, http://online.wsj.com/article/SB100014240527487 04421304575383550518554386.html. 38. Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices: Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 111th Cong. 3 (2010) (Table 1) (statement of Gregory Kutz, Managing Director, Forensic Audits and Special Investigations, Government Accounta-bility Office) [hereinafter Statement of Gregory Kutz]. 39. Id. at 5 (Figure 1). 40. Id. at 9. 41. Id. at 16 (Table 2).

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I. EXISTING REGULATIONS

Government oversight of DTC genetic tests “currently falls between several regulatory ‘cracks’ within the federal government.”42 The Food and Drug Administration (“FDA”) and the Centers for Medicare and Medicaid Services (“CMS”)—through the Clinical Laboratory Improvement Amend-ments (“CLIA”)—provide some regulation over the laboratory process.43 The Federal Trade Commission has the potential to cover false, deceptive or mis-leading advertising by DTC genetic test companies,44 but no government agency directly regulates these tests, creating a regulatory gap for DTC tests. Part I outlines the current regulatory framework and the latest government overtures to provide oversight.

A. Food and Drug Administration

The FDA regulates a broad array of food, drug, cosmetics, and medical device manufacturers through the Food, Drug, and Cosmetic Act (“FDCA” or “the Act”).45 The original Food and Drugs Act of 1906 only applied to drugs since essentially no medical device industry existed in the early part of the century; Congress did not give the FDA explicit jurisdiction over medical devices until 1938.46 The 1906 Act confined the agency’s authority to chal-lenging the sale of products that it believed were adulterated or misbranded, so the FDA had no authority to require the manufacturer to prove the safety or efficacy of the product.47 The 1906 Act was premised on the assumption that the average consumer was “prudent enough to plot his own course” and would avoid risks as long as the labeling made him aware of them.48 As a re-sult, the 1938 Act “focused on protecting the consumer from harm and de-ceitful marketing practices.”49

Lack of pre-market approval for medical devices, however, became an issue as complex devices proliferated, and some failed. According to the Su-

42. Javitt et al., supra note 14, at 254. 43. Jennifer A. Gniady, Note, Regulating Direct-to-Consumer Genetic Testing: Protecting the Con-sumer Without Quashing a Medical Revolution, 76 FORDHAM L. REV. 2429, 2436 (2008). 44. Katherine Drabiak-Syed, Baby Gender Mentor: Class Action Litigation Calls Attention to a Deficient Federal Regulatory Framework for DTC Genetic Tests, Politicized State Statutory Construction, and a Lack of Informed Consent, 14 MICH. ST. U. J. MED. & L. 71, 76, 77 (2010) (As recently as 2010, the FTC has declined to regulate DTC genetic tests, but did issue a warning to consumers to be weary of such tests). 45. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (West 2011). For an extensive history of the FDCA, see Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753 (1996). 46. Merrill, supra note 45, at 1801-02. 47. Id. at 1802-03. 48. Gniady, supra note 43, at 2437. 49. Id.

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preme Court, the most notable failure involved the Dalkon Shield intrauterine device, which was introduced in 1970 and “linked to serious infections and several deaths” as well as a large number of pregnancies; the device thus proved dangerous and defective.50 Congress responded with a detailed regime of federal oversight with the passage of the Medical Device Amendments of 1976.51 Those amendments to the FDCA gave the FDA the power to pre-scribe manufacturing practice requirements for devices and to ban worthless or dangerous products.52

The Act describes the FDA’s mission to include “protect[ing] the public health by ensuring that . . . there is reasonable assurance of the safety and effectiveness of devices intended for human use.”53 According to the Supreme Court, “[v]iewing the FDCA as a whole, it is evident that one of the Act’s core objectives is to ensure that any product regulated by the FDA is ‘safe’ and ‘effective’ for its intended use.”54

To carry out this purpose in relation to genetic tests, the FDCA grants the FDA authority to regulate medical devices, the category under which ge-netic tests likely fall if covered by the FDCA.55 The Center for Devices and Radiological Health (“CDRH”) of the FDA regulates medical devices.56 The FDCA defines a medical device as:

[A]n instrument, apparatus, implement, machine, contrivance, im-plant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.57

This broad definition encompasses equipment, reagents, and other com-ponents used by laboratories to analyze human specimens for the “cure, miti-

50. Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). 51. Id. at 316. 52. Merrill, supra note 45, at 1808. 53. 21 U.S.C. § 393(b)(2) (West 2011). 54. FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000) (citing 21 U.S.C. § 393(b)(2) (1994 ed., Supp. III)). 55. Genetics & Pub. Policy Ctr., FDA Regulation of Genetic Tests, JOHNS HOPKINS U., http://www.dnapolicy.org/images/issuebriefpdfs/FDA_Regulation_of_Genetic_Test_Issue_Brief.pdf (last updated May 30, 2008) [hereinafter FDA Regulation of Genetic Tests]. Laboratory developed tests (LDTs), discussed infra note 100 and accompanying text, could be defined as clinical laboratory services, not medical devices, because the actual product never leaves the laboratory to enter the consumer’s possession. The consumer provides a genetic sample to a lab, who processes that sample and delivers results; the consumer does not handle the kit itself. CMS regulates laboratory services through CLIA. See infra notes 127-44 and accompanying text. 56. Joseph F. Sucher, Stephen L. Jones & Isaac D. Montoya, An Overview of FDA Regulatory Requirements for New Medical Devices, 3 EXPERT OPINION ON MED. DIAGNOSTICS 5, 6 (2009), available at http://informahealthcare.com/loi/edg. 57. 21 U.S.C. § 321(h)(2) (West 2011).

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gation, treatment, or prevention of disease.”58 The FDA currently regulates such tests as “in vitro diagnostic devices” or IVDs.59 Through its regulations, the FDA ensured that any IVD could be regulated as a device; these regula-tions define IVD products as:

[T]hose reagents, instruments, and systems intended for use in the di-agnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) [21 U.S.C. § 321(h)] of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.60

Like all medical devices, the FDA assigns each IVD “to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.”61 The class determines, among other things, the type of pre-market submissions or applications required for FDA clear-ance to market.62 This tiered system assures careful review of the few high risk technologies but allows less intrusive regulation of most devices. Class I de-vices require the least regulatory oversight.63 The FDA subjects these devices to only basic FDA regulatory mechanisms, including good manufacturing practices, registration, and general prohibitions against misbranding and adul-teration.64 The FDCA allows these devices onto the market without submis-sion to the FDA of a pre-market application, as required of Class III devices discussed below.65 One example of a Class I test is a luteinizing hormone test that may lead to delayed conception if it gives a false result, but it is unlikely to directly harm the patient.66 Other common examples of Class I devices in-clude elastic bandages and examination gloves.67

The FDA considers Class II devices to be slightly more risky and may place “special controls” on these devices, such as performance standards and post-market surveillance.68 If a Class II device does not comply with a special

58. FDA Regulation of Genetic Tests, supra note 55 (internal citations omitted); See 21 U.S.C. § 321(h)(2). 59. FDA Regulation of Genetic Tests, supra note 55. 60. 21 C.F.R. § 809.3(a) (West 2011). 61. U.S. Food and Drug Administration, Medical Devices, Classify Your Medical Device, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm (last updated Apr. 27, 2009). 62. Id. 63. Patsner, supra note 24, at 245. 64. Id. 65. 21 U.S.C. § 360(l) (West 2011). 66. Statement of Jeffrey Shuren, supra note 10. 67. Riegel, 552 U.S. at 316-17. 68. 21 U.S.C. § 360c(a)(1)(B) (West 2011). Post-market surveillance can include reporting of device malfunctions, reporting of serious injuries or deaths caused by use of the device, and

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control, the FDA considers the device adulterated.69 A sodium test is an ex-ample of a Class II test because a false result may be life-threatening if the error goes unrecognized and the patients or physicians make treatment deci-sions to correct the sodium level based on the false result.70 A powered wheelchair is also a Class II device.71

Most Class II devices enter the market through the 510(k) clearance mechanism rather than the more complicated pre-market approval application (“PMA”) required of Class III devices.72 A 510(k), so named for its place in the FDCA, allows the device manufacturer to demonstrate to the FDA in a pre-market submission that their device is at least as safe and effective—that is, substantially equivalent—to an approved device not subject to a PMA.73 Manufacturers compare their device to another device already approved by the FDA—a predicate device—and provide support for their substantial equivalency claims. Only ten percent of 510(k) applications include clinical data.74 Since clinical data is not required,75 the other ninety percent do not provide any such data. Until the FDA approves the substantial equivalency determination, the device may not be legally marketed in the United States.76

A PMA, on the other hand, “is the most stringent type of device market-ing application required by [the] FDA.”77 The PMA is a “‘rigorous’ process”78 and calls for extensive safety and efficacy data for Class III devices.79 The FDCA defines Class III devices as those that:

(1) cannot be Class I or Class II devices because general and special controls would not be adequate to provide reasonable assurance of

the safety and effectiveness of the device; and

registering the establishments where devices are produced or distributed. U.S. Food and Drug Administration, Postmarket Requirements (Medical Devices), available at http://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/PostmarketRequirements/default.htm (last updated Aug. 3, 2009). 69. Patsner, supra note 24, at 246. 70. Statement of Jeffrey Shuren, supra note 10. 71. Riegel, 552 U.S. at 316. 72. Patsner, supra note 24, at 246. 73. 21 C.F.R. § 807.92(a)(3) (West 2011). 74. Sucher et al., supra note 56, at 7. 75. Medical Devices: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspec-tions of Device Manufacturing Establishments: Hearing Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 111th Cong. 5 (2009) (statement of Marcia Crosse, Director, Health Care, Government Accountability Office) [hereinafter Statement of Marcia Crosse]. 76. 21 U.S.C. § 36(o)(1)(B) (West 2011). 77. U.S. Food and Drug Administration, Premarket Approval (Medical Devices), available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm (last updated Sept. 3, 2010). 78. Riegel, 552 U.S. at 317 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996)). 79. Patsner, supra note 24, at 247.

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(2) the use of which either: (a) supports or sustains human life, (b) is of “substantial importance in preventing impairment of human health,” or (c) “presents a potential unreasonable risk of illness or injury.”80

A hepatitis C virus test is one example of a Class III test; a false negative result could lead to liver failure due to delayed treatment, and the patient may put others at risk by unknowingly spreading the disease.81 Replacement heart valves and pacemakers would also be classified as Class III devices.82 These devices can only be marketed after approval of a PMA.83 The PMA requires a manufacturer to submit, among other things, nonclinical laboratory data and data from clinical investigations involving human subjects.84

After completing its review, which takes an average of 1200 hours,85 the FDA may grant or deny pre-market approval.86 The FDA may condition its approval on “adherence to performance standards, 21 C.F.R. § 861.1(b)(3), restrictions upon sale or distribution, [device-specific restrictions,] or compli-ance with other requirements.”87 As a result, the PMA process takes longer and is more complicated than a 510(k) clearance.88 The PMA requirements can result in substantial cost and delay.89 For example, the standard fee for 510(k) submissions in fiscal year 2009 was $3693, while original PMA appli-cants had to pay $200,725.90 The FDA also generally makes decisions on 510(k) submissions faster than it makes decisions on PMA applications. For example, in 2009, the FDA’s goal was to review and decide on ninety percent of 510(k) submissions within ninety days; its comparable goal for PMAs was ninety percent in 295 days.91 The average review time for a 510(k) submission is approximately three months, while a PMA application takes 9.5 months.92 The time and expense devoted to clinical studies alone can drive up the cost

80. 21 U.S.C. § 360c(a)(1)(C)(ii)(I)-(II) (West 2011). 81. Statement of Jeffrey Shuren, supra note 10. 82. Riegel, 552 U.S. at 317; Lohr, 518 U.S. at 477. 83. Lohr, 518 U.S. at 477. The FDA does provide one exception for new devices; if a substantially equivalent medical device existed on the U.S. market prior to May 28, 1976, a 510(k) clearance can be used. Patsner, supra note 24, at 246. 84. U.S. Food and Drug Administration, PMA Application Contents (Medical Devices), available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYour Device/PremarketSubmissions/PremarketApprovalPMA/ucm050289.htm (last updated Aug. 23, 2010). 85. Lohr, 518 U.S. at 477. By contrast, the 510(k) clearance can occur in an average of twenty hours. Id. at 479. 86. See 21 U.S.C. § 360e(d)(1)(A)(i)-(ii) (West 2011). 87. Riegel, 552 U.S. at 319. 88. Gail H. Javitt, In Search of a Coherent Framework: Options for FDA Oversight of Genetic Tests, 62 FOOD & DRUG L.J. 617, 619 (2007). 89. Juliana Han, Note, The Optimal Scope of FDA Regulation of Genetic Tests: Meeting Challenges and Keeping Promises, 20 HARV. J. L. & TECH. 423, 427 (2007). 90. Statement of Marcia Crosse, supra note 75, at 5-6. 91. Id. at 5. 92. Id.

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to Class III device manufacturers because clinical studies for a Class III medi-cal device can take four to five years and cost between $15 and $20 million.93

Currently, however, the FDA only regulates genetic tests as IVDs “if the components of the test are bundled together, labeled for a particular use, and sold to an outside laboratory as a unit” or “test kit[].”94 Test kits are complete test systems that contain all the “reagents, components, and instructions needed to conduct the test and are intended for sale to multiple outside labor-atories.”95 The FDA thus far classified the handful of genetic tests that fit this definition as Class II or Class III devices, subjecting them to 510(k) or PMA approval processes.96

The vast majority of the thousands of DTC genetic tests available today, though, circumvent the FDA approval process and its safeguards because they are not sold as test kits.97 Instead, laboratories develop a test “in-house” using commercial or self-created components and market the test to physicians or patients as a proprietary testing service.98 This is the classic set-up for most DTC genetic test companies. For example, 23andMe collects a saliva sample from the consumer and processes the sample in the company’s laboratory, using a protocol developed by that laboratory. The laboratory does not com-mercially distribute a test kit; it commercially distributes services derived from the development and performance of a test in house.99 These tests are com-monly known as “home brew” or “laboratory-developed tests” (“LDTs”) to differentiate them from test kits.100 FDA asserts that it has the authority to regulate LDTs, but it has not yet done so, exercising “enforcement discre-tion.”101 As a result, LDTs can enter the market without having to undergo

93. Jordan Paradise, Alison W. Tisdale, Ralph F. Hall, & Efrosini Kokkoli, Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology, 37 J.L. MED. & ETHICS 598, 602 (2009). 94. FDA Regulation of Genetic Tests, supra note 55. 95. Han, supra note 89, at 427. 96. See Javitt, supra note 88, at 629-32. 97. Andrew S. Robertson, Note, Taking Responsibility: Regulations and Protections in Direct-to-Consumer Genetic Testing, 24 BERKELEY TECH. L.J. 213, 223-24 (2009); Drabiak-Syed, supra note 44, at 73 (“[O]nly about one percent of commercially available genetic tests meet the definition of test kit and are regulated by the FDA.”); Statement of Jeffrey Shuren, supra note 10 (estimating that 2500-5000 LDT’s exist). 98. Peter M. Kazon, Regulatory Issues Facing Genetic Testing, 3 J. HEALTH & LIFE SCI. L. 111, 117 (2010). 99. Solberg, supra note 29, at 714. 100. Kazon, supra note 98, at 117. 101. Statement of Jeffrey Shuren, supra note 10. According to the FDA, when the device law was updated in 1976:

[T]ests made by laboratories were generally low-risk diagnostic tools or relatively sim-ple, well-understood tests that diagnosed rare diseases and conditions, and which were more dependent on expert interpretation. Therefore, the accuracy of the results was more dependent on the expertise of the pathologist/laboratorian than on the design of the test. Furthermore, these LDTs were used by pathologists/laboratorians and the re-

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any FDA pre-market evaluation for safety, effectiveness, accuracy, or con-sistency of the test itself.102

In 2010, however, the FDA indicated that it may try to bring LDTs un-der the medical device regulatory umbrella through enforcement of govern-ment oversight. Citing recent concerns, including faulty data analysis, exagger-ated clinical claims, and unacceptable clinical performance, the FDA told a House subcommittee that the agency believed enforcement of regulations on LDTs could ensure accuracy and safety for consumers.103 Putting force be-hind these words, the FDA notified Pathway Genomics Corporation (“PGC”) on May 10, 2010 that their genetic test could be regulated as a medical device under the FDCA and that clearance or approval by the FDA was necessary before PGC could market their product.104 On June 10, 2010, the FDA sent similar letters to four other companies: Knome, Inc.; Navigenics; deCODE Genetics; and 23andMe.105 Nine days later, the FDA sent letters to fifteen other DTC genetic testing firms.106

Congress has made at least two recent attempts to give the FDA explicit jurisdiction over LDTs. In 2006, then Senator Obama introduced the Ge-nomics and Personalized Medicine Act that would have developed a decision matrix for determining which genetic tests, including LDTs, should require governmental review.107 In order to “realiz[e] the potential of personalized medicine,” Obama’s proposal required the Secretary of Health and Human Services to “improve the safety, efficacy, and availability of information about genetic tests, including pharmacogenetic” tests.108 The Secretary would devel-op a “decision matrix” to improve the oversight and regulation of genetic tests by:

(1) determining the classification of genetic tests that have not yet been classified or whose classification is unclear or questioned; (2) determining which types of tests, including LDTs, require review and the level of review needed;

sults were reported to physicians within a single institution where both professionals were actively involved in the care of the patient being tested.

Id. 102. Patsner, supra note 24, at 254. 103. Statement of Jeffrey Shuren, supra note 10. 104. Id. 105. U.S. Food and Drug Administration, Medical Devices, Letters to Industry, Letter to 23andMe, Inc., Concerning the 23andMe Personal Genome Service (June 10, 2010), available at http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240 .pdf. In language nearly copied in ever letter, the FDA told 23andMe: “The [test offered by 23andMe] is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act . . . because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” Id. 106. Statement of Jeffrey Shuren, supra note 10, at 12. 107. Genomics and Personalized Medicine Act of 2006, S. 3822, 109th Cong. (2006). 108. Id. § 7(b)(1).

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(3) determining which agency shall have oversight of the review process; and (4) determining which requirements the agency shall apply to the tests.109 In deciding on the level of review needed by a genetic test, Obama’s bill

required the Secretary to consider the characteristics of the test and its target disease or condition, the intended use of the test, the potential for improved medical conditions and patient harms, and the social consequences of the test.110 The late Senator Kennedy introduced a bill in 2007 that would have amended the FDCA to explicitly include DTC genetic tests and require manu-facturers to go through the 510(k) clearance process before such tests could reach the market.111 Both bills, however, died in committee.

The “regulatory black hole”112 created by a lack of FDA regulation has shrunk slightly in the past decade, however. In 1997, the FDA announced it would consider Analyte Specific Reagents (“ASRs”), the building blocks of LDTs, to be medical devices subject to the FDCA.113 ASRs are the active ingredients of a laboratory test used to diagnose genetic conditions;114 specifi-cally, they are “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are in-tended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.”115

FDA oversight of ASRs, however, remains quite narrow. First, the FDA classifies most ASRs as Class I devices, providing the weakest level of over-sight.116 Most ASRs, then, must only comply with general controls.117 Second,

109. Id. § 7(b)(3)(A). 110. Id. § 7(b)(3)(B). 111. Laboratory Test Improvement Act, S. 736, 110th Cong. (2007). The Kennedy bill would have also created a genetic specialty for the Clinical Laboratory Improvements Act, discussed infra Part II Section B. 112. Patsner, supra note 24, at 255. 113. Kazon, supra note 98, at 118-19. Since the FDCA depends on Congress’ Commerce Clause authority for its constitutional validity, opponents of FDA regulation of LDTs could argue that laboratory tests that developed and marketed within one state cannot be regulated as interstate commerce. This argument, though, is likely to fail under current Supreme Court doctrine. Congress may regulate: (1) the channels of interstate commerce; (2) the instrumentali-ties of interstate commerce, or persons or things in interstate commerce, even though the threat may come only from intrastate activities; and (3) activities having a substantial relation to inter-state commerce. U.S. v. Lopez, 514 U.S. 549, 558 (1995). The Court would likely uphold regu-lations under this last category, since precedent has upheld regulations of activities that arise out of or are connected with a commercial transaction, which substantially affects interstate com-merce when viewed in the aggregate. See, e.g., Wickard v. Filburn, 317 U.S. 111 (1942). The Court would likely conclude that LDTs affect interstate commerce when viewed in the aggre-gate, even if a single laboratory confines its work to a single state. Failure to regulate the intra-state activity could undercut the regulation of the interstate market in LDTs. 114. Solberg, supra note 29, at 719. 115. 21 C.F.R. § 864.4020(a) (West 2011). 116. Javitt, supra note 88, at 620.

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the FDA only regulates ASRs that move in interstate commerce, exempting ASRs created in-house and used exclusively by that laboratory for in-house genetic testing.118 Third, FDA regulations state that commercially distributed ASRs must be ordered by a health professional or “other persons authorized by state law,” but the FDA does not seem to have enforced this provision; even if it did enforce it, the provision does not distinguish between an outside physician or the laboratory’s own physician-employee.119 Finally, the FDA regulates only the reagents themselves, not how the laboratories assemble the reagents to produce the test.120

The FDA has also issued draft guidance for the regulation of one small “subset of LDTs that the agency terms in vitro diagnostic multivariate index assays (“IVDMIAs”).”121 These tests combine the values of multiple variables gathered from laboratory data using an algorithm to yield a single, patient-specific result for the purpose of diagnosis, treatment, or prevention of dis-ease.122 The test thus “[p]rovides a result whose derivation is non-transparent and cannot be independently derived or verified by the end user.”123 “Most IVDMIAs would be classified as Class II or III medical devices.”124 and “[t]he FDA cleared its first application for an IVDMIA in February 2007.”125 Most DTC genetic tests, though, would not be considered IVDMIAs,126 leaving the majority of DTC genetic tests free from FDA oversight at this time.

B. Clinical Laboratory Improvement Amendments

The Centers for Medicare and Medicaid Services also provides some regulatory oversight of genetic tests through the CLIA of 1988.127 CLIA re-

117. Id. 118. Solberg, supra note 29, at 719. 119. FDA Regulation of Genetic Tests, supra note 55. 120. Gregory Katz & Stuart O. Schweitzer, Implications of Genetic Testing for Health Policy, 10 YALE J. HEALTH POL’Y L. & ETHICS 90, 123 (2010). 121. FDA Regulation of Genetic Tests, supra note 55. 122. Magnus et al., supra note 24, at 2-3. 123. Id. at 3. 124. Gregorio M. Garcia, The FDA and Regulation of Genetic Tests: Building Confidence and Pro-moting Safety, 48 JURIMETRICS J. 217, 223 (2008). 125. Hogarth et al., supra note 3, at 173. 126. Id. 127. Sec’y’s Advisory Comm. on Genetics, Health, and Soc’y, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services 3 (2008) [herein-after SACGHS Oversight Report]. States can be exempt from the CLIA requirements if they develop requirements that are as strict or stricter than the federal requirements; New York and Washington are the only states to have done so. Id. States can also implement broader controls to supplement CLIA. Id. Congress’ constitutional authority to legislate over private laboratories that do not put products into interstate commerce is not explicitly clear in the CLIA regula-tions, but a federal court may uphold congressional authority on two grounds. See supra note 113. First, Congress could regulate a laboratory if it decides that the laboratory’s activities would affect interstate commerce in the aggregate. See supra note 113. Second, “congressional

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quires CMS to certify laboratories that perform testing regarding the “diagno-sis, prevention, or treatment of any disease.”128 Unlike the FDA, which re-quires devices to undergo an external regulatory review process to substantiate claimed performance characteristics, CLIA takes a process-oriented approach that focuses on factors such as credentials of laboratory personnel and labora-tory testing procedures.129 In other words, CLIA focuses on “intra-laboratory processes” rather than the “clinical uses of test results.”130 The standards set by CLIA provide for quality control and assurance; they do not address addi-tional aspects of testing, such as clinical validity or clinical utility.131 CLIA also does not regulate what laboratories may say in communications promoting genetic tests, nor does it impose any obligation on laboratories to communi-cate or to explain the meaning and limitations of specific tests.132 Congress enacted CLIA solely to ensure that laboratories execute medical testing con-sistently and in a valid and reliable manner.133

CLIA categorizes all laboratory tests as one of the following: (1) “waived tests;” (2) “tests of moderate complexity;” and (3) “tests of high complexity.”134 Waived tests are simple laboratory tests which are cleared by the FDA

for home use, “[e]mploy methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible[,]” or “[p]ose no reasona-ble risk of harm to the patient if the test is performed incorrectly.”135 CLIA classifies other tests as moderate or high complexity based on a series of fac-tors, including the training and experience needed to conduct the test and the reagents and materials used to perform the test.136

CLIA further divides some high complexity and moderate complexity tests into specialty and sub-specialty areas to establish more stringent stand-

judgment that an exemption for such a significant segment of the total market would under-mine the orderly enforcement of the entire regulatory scheme is entitled to a strong presump-tion of validity.” Gonzales v. Raich, 545 U.S. 1, 28-29 (2005). In other words, exempting private laboratories from the regulatory scheme could conceivably hinder Congress’ ability to regulate all laboratories providing genetic testing services, so a court should allow Congress to regulate the entire class of laboratories under the Commerce Clause. 128. Drabiak-Syed, supra note 44, at 78. 129. SACGHS Oversight Report, supra note 127, at 30. 130. Douglas A. Grimm, FDA, CLIA, or a “Reasonable Combination of Both”: Toward Increased Regulatory Oversight of Genetic Testing, 41 U.S.F. L. REV. 107, 121 (2006). 131. Id. 132. Javitt et al., supra note 14, at 271. 133. Robertson, supra note 97, at 222. 134. 42 C.F.R. § 493.5(a)(1)-(3) (West 2011). 135. 42 C.F.R. § 493.15(b)(1)-(3) (West 2011). 136. 42 C.F.R. § 493.17(a), (a)(2) (West 2011). The regulations assign a score of one, two, or three to a series of seven factors. Id. § 493.17(a). If the total score is higher than twelve, the test is classified as high complexity. Id. If the total score is twelve or less, the test is considered to be of moderate complexity. Id.

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ards that a lab must follow to be CLIA certified.137 To earn CLIA certifica-tion, each laboratory conducting tests in these specialty areas must enroll in proficiency testing,138 which assesses compliance with specific standards for the specialty and whether the laboratory can obtain the correct result on a sample provided by the proficiency testing program.139 For tests without a CLIA specialty, the laboratory must only establish and maintain the accuracy of its testing procedures.140 In other words, these tests must only follow gen-eral guidelines that do not measure accuracy according to particular standards for that type of test.141

Currently, no genetic specialty exists—though the Clinical Laboratory Improvement Advisory Committee (“CLIAC”) has stated that a “discrete genetic testing section should be added”142—so CLIA does not hold laborato-ries that conduct genetic tests to any particular standard for accuracy, reliabil-ity, or clinical validity.143 As a result, a genetic test conducted by a CLIA-approved laboratory does not need to show a strong connection between the results of a genetic test and the disease or condition that a positive result is supposed to predict.144 CLIA, then, only governs the conduct of the laboratory, not the accuracy of the results obtained by the test. CLIA merely assures that the laboratory conducts the genetic test in a scientifically valid and reliable manner.

C. Federal Trade Commission

The Federal Trade Commission (“FTC”) can also protect consumers by regulating advertising of DTC genetic tests.145 The FTC administers many consumer protection laws, especially those related to unfair or deceptive trade practices, such as misleading advertising claims.146 This jurisdiction is especial-ly relevant to DTC genetic testing because companies market their products directly to the consumer rather than relying on physicians or health care com-panies to order the tests. If a company offering a DTC genetic test makes claims of clinical validity without adequate scientific evidence, the FTC can

137. Novick, supra note 12, at 626. 138. 42 C.F.R. § 493.801(West 2011). 139. Id. at (a)(2)(i), (a)(4)(i). 140. Id. at (a)(2)(ii). 141. Some argue that CLIA could also ensure clinical validity, but it has refused to do so because adding clinical validity requirements to the CLIA regulations would overlap with the FDA’s role. SACGHS Oversight Report, supra note 127, at 32. CMS, therefore, has continually declined to enforce clinical validity requirements. Hogarth et al., supra note 3, at 170. 142. Garcia, supra note 124, at 220. 143. Gniady, supra note 43, at 2440. 144. Novick, supra note 12, at 627. 145. Molly C. Novy, Note, Privacy at a Price: Direct-to-Consumer Genetic Testing & the Need for Regulation, 2010 U. ILL. J.L. TECH. & POL’Y 157, 174 (2010). 146. Robertson, supra note 97, at 227.

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bring an enforcement action to prohibit such claims.147 Despite consumer complaints of such erroneous claims, however, the FTC has not yet taken action against DTC genetic test companies.148 Instead, the FTC issued a con-sumer alert on genetic tests, warning potential consumers to be skeptical of company claims and to speak with a physician or medical practitioner before and after taking a genetic test.149

II. THE CASE FOR REGULATION, MORE OR LESS

Before the government implements a public policy that increases regula-tion over DTC genetic tests, the government should consider the ethical framework that best fits genetic technologies. Ethical analysis enlightens poli-cy formation.150 In recognition of this reality, the U.S. government has created numerous national commissions, advisory committees, and councils to formu-late guidelines for a variety of biomedical issues.151 Most recently, President Obama established the Presidential Commission for the Study of Biomedical Issues “to identify[] and promot[e] policies and practices that ensure scientific research, healthcare delivery, and technological innovation are conducted in an ethically responsible manner.”152

As a primary step, regulators must choose an ethical model that best fits the DTC genetic test market. With a particular model as the starting point, the government can make better policy because it will be forced to start from a “series of assumptions about how the area should be regulated and then justi-fy any departures from that approach.”153 Four acclaimed possibilities exist for DTC genetic tests: the medical model, the public health model, the fundamen-tal rights model, and the business model.

According to Beauchamp and Childress’ Principles of Biomedical Ethics, four primary moral principles create a suitable starting point for medical ethics:

(1) autonomy, a norm of respecting and supporting autonomous decisions; (2) beneficence, a group of norms pertaining to preventing harm and providing benefits; (3) nonmaleficence, a norm of avoiding the causation of harm; and (4) justice, a group of norms for fairly distributing benefits, risks, and costs.154

147. Hogarth et al., supra note 3, at 174. 148. Drabiak-Syed, supra note 44, at 77. 149. Fed. Trade Comm’n, At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription (2006) available at http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.pdf. 150. TOM L. BEAUCHAMP & JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 8 (6th ed., Oxford University Press 2009). 151. Id. at 8-9. 152. Proclamation No. 13,521, 74 Fed. Reg. 62,671 Sec. 2(a) (Nov. 24, 2009). 153. LORI B. ANDREWS, FUTURE PERFECT 151 (Columbia University Press 2001). 154. BEAUCHAMP & CHILDRESS, supra note 150, at 12-13.

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On the surface, Beauchamp and Childress’ model appears to provide a sturdy framework for DTC genetic testing. For instance, the autonomy prong of the medical model promotes informed consent by ensuring that consumers have the ability to voluntarily choose a course of action and the competency to make an informed decision. To this end, the model states that “personal autonomy encompasses, at a minimum, self-rule that is free from both con-trolling interference by others and from certain limitations such as an inade-quate understanding that prevents meaningful choice.”155

Reliance on the physician as gatekeeper of the genetic test, however, ul-timately proves the medical model an unsuccessful structure for DTC genetic testing. The mandates of beneficence and nonmaleficence direct the physician to protect the patient, but they offer little to guarantee quality assurance of the genetic test itself. The medical model uses malpractice liability to assure quali-ty, but this solution insufficiently protects the consumer for two reasons: first, errors in late-onset testing may not be discovered for years or decades; and second, suits over genetic information may either be barred by statute or diffi-cult to prove at common law.156 The medical model is a backward enforcing model that compensates victims of negligence after they have been harmed. A more suitable model would provide prospective quality assurance by instituting standards on the laboratory developing the genetic tests. A prospective mode of enforcement can correct errors before they affect a patient, an important distinction when errors may not present themselves for decades.

The public health model presents a second option for DTC genetic test-ing. “[P]ublic health aims to understand and ameliorate the causes of disease and disability in a population,”157 so relevant general moral considerations may include: producing benefits; avoiding, preventing, and removing harms; dis-tributing benefits and burdens fairly; and respecting autonomous decisions and actions.158 Whereas the medical model focused on the physician-patient relationship, the public health model offers broader access to a wide array of actors—including professionals, the community, and government—with an accompanying broader focus on fundamental social conditions that affect population levels of morbidity and mortality.159 This model works well for infectious disease, but it begins to break down when applied to genetic testing. First, the public health model focuses on diseases that affect populations, not individuals. A genetic disease may be widespread and affect numerous people, but it does not carry the highly contagious or imminently dangerous tag that puts the public at large at risk.160 Second, the traditional public health goal of

155. Id. at 99. 156. ANDREWS, supra note 153, at 152. 157. James F. Childress et al., Public Health Ethics: Mapping the Terrain, 30 J.L. MED. & ETHICS 170 (2002). 158. Id. at 171-72. 159. Id. at 170. 160. ANDREWS, supra note 153, at 154.

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prevention does not readily apply to genetic testing.161 Public health educators typically attempt to change behavior to prevent disease and to change atti-tudes and values, which then leads to behavior changes, but this approach would not work for many genetic diseases or conditions that cannot be pre-vented or altered with behavioral changes.162

Lori Andrews’ fundamental rights model offers an alternate model for regulation DTC genetic tests. The fundamental rights model focuses on three issues:

(1) voluntariness of genetic testing; (2) provision of information to patients; and (3) quality assurance.163 These three precepts combine the valuable autonomy portion of the

medical model with statutory, FDA-like regulations that provide prospective quality assurance. The model thus appears to “fix” the medical model to make it appropriate for DTC genetic tests. Andrews’ model, however, supplies a framework that is too broad for the regulation of DTC genetic test compa-nies. The first two principles of the fundamental rights model assume a physi-cian-patient relationship.164 This model places the duty to inform on the phy-sician while the manufacturer complies with regulations designed to assure quality of the product. The model separates the information-inducing portion from the responsibility to comply with quality assurance regulations. Current-ly, though, DTC genetic testing does not involve a physician in all instances; if a physician-patient relationship is present, it exists outside the manufacturer-consumer relationship. Ethical burdens placed on physicians, then, do not affect the marketing of DTC genetic tests unless regulations require all testing to proceed through a health care provider.165 Channeling all genetic tests through a physician, though, essentially closes the DTC market altering the acronym from direct-to-“consumer” to indirectly to the consumer through a physician or other health care provider.

The business ethics model, on the other hand, can incorporate the in-formation production principle, ensure quality of the genetic test itself, and preserve the DTC nature of the technology. While determining fundamental business ethics principles may be compared to “nailing jello to a wall,”166 a general code of ethics may include: “exercise of due care, confidentiality, fidel-ity to special responsibilities, avoidance of the appearance of a conflict of in-

161. Id. at 159. 162. Id. at 155. 163. Id. at 161-70. 164. For example, Andrews writes of tissues collected in the clinical setting, id. at 163, and a responsibility of physicians to provide information to their patients, id. at 165. 165. Germany has debated such a law. See Germany Limits Genetic Testing, SIGNON SAN

DIEGO (Apr. 24, 2009), available at http://www.signonsandiego.com/news/2009/apr/24/eu-germany-genetic-testing-042409. 166. See Phillip V. Lewis, Defining ‘Business Ethics’: Like Nailing Jello to a Wall, 4 J. BUS. ETHICS 377 (1985).

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terest, willing compliance to the law, acting in good faith in negotiations, re-spect for human well-being, [and] respect for the liberty and constitutional rights of others.”167 “While corporate managers are fiduciaries who must se-cure the highest attainable profits for their principals, they may only pursue profit in ways that promote authentic human flourishing,” including the pro-motion of human health.168 The typical corporate code of ethics of a large public company contains policy statements or admonitions that generally fall into one or more of five overlapping categories:

(1) “follow the law;” (2) “be honest;” (3) “avoid conflicts of interest;” (4) “keep the company’s secrets;” and (5) treat stakeholders—including customers—and competitors with fairness and respect.169 One proposed business ethics model proposes a series of questions to

put to a firm, including the following three queries: does the company comply with the law?; how honestly do product claims match with reality?; and, how forthcoming is the company with information?170

A look at specific codes of ethics of medical technology companies can provide more substance to these generic principles. For example, Medtronic, a leading supplier of medical technology, established a code of ethics that in-cludes fair dealing with the consumer, quality assurance of the product, avoid-ance of conflicts of interests, and respect of the physician-patient relation-ship.171 Medtronic defines fair dealing as not taking advantage of a customer through “manipulation, concealment, abuse of privileged information, misrep-resentation of material facts, or any other unfair-dealing practice.”172

The Human Genetics Commission (“HGC”), the United Kingdom’s government advisory body on new developments in human genetics, supplies additional frameworks that can further define a business ethics model for

167. Peter J. Dean, Making Codes of Ethics ‘Real’, 11 J. BUS. ETHICS 285, 288 (1992). 168. Joseph S. Spoerl, The Social Responsibility of Business, 42 AM. J. JURIS. 277, 297 (1997). One author stated that a business’ social responsibilities constitute, in order, (1) profit maximi-zation, (2) obedience to the law, and (3) fulfillment of ethical responsibilities. Archie B. Carroll, Ethical Challenges for Business in the New Millennium: Corporate Social Responsibility and Models of Man-agement Morality, 10 BUS. ETHICS Q. 33, 37-38 (2000). 169. Joshua A. Newberg, Corporate Codes of Ethics, Mandatory Disclosure, and the Market for Ethical Conduct, 29 VT. L. REV. 253, 258 (2005). Other authors have listed the most commons principles as: (1) “fairness;” (2) “honesty and honest communication;” (3) “keeping promises;” and (4) “doing no harm.” Michael Distelhorst, A Business Ethics Approach to Contractual Good Faith and Fair Dealing: Briefly Modeled in Selected Managed Healthcare Contexts, 26 OHIO N.U. L. REV. 57, 72 (2000). 170. Marianne M. Jennings & Jon Entine, Business with a Soul: A Reexamination of What Counts in Business Ethics, 20 HAMLINE J. PUB. L. & POL’Y 1, 62-70 (1998). 171. Medtronic, Code of Conduct, available at http://www.medtronic.com/corporate-governance/principles-and-ethics/code-of-conduct/index.htm (last visited Nov. 10, 2010). 172. Id. at 3.

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DTC genetic test companies.173 The HGC principles explicitly cover situations in which a physician may not be involved.174 The HGC first advises that all marketing of tests should be truthful and candid; the promotion and technical claims should accurately describe both the characteristics and the limitations of the tests offered and should be supported by scientific evidence.175 Addi-tionally, the test provider should supply easily understood, accurate, appropri-ate, and adequate information to consumers.176 That information should be given in a context of pre- and post-test support, and the company should supply customers with information about health professionals who can offer further advice or support.177 Second, the data should comply with quality as-surance regulations.178

Using these examples as guides, a business ethics model specially target-ed to DTC genetic test companies emerges that provides an appropriate framework for consideration of increased regulation of the DTC genetic test market. First, companies must exercise due care and respect human well-being by requiring informed consent from consumers before a genetic test may be purchased. In other words, the company must ensure proper information dissemination to adequately inform the customer of the product’s advantages and disadvantages; this will safeguard against manipulation of the consumer. Second, the company must provide quality assurance of the genetic test, in-cluding analytic and clinical validity.

The business ethics model also makes pragmatic sense as a framework for manufacturers of DTC genetic tests. The medical, the public health, and the fundamental rights models all approach this issue from a clinical or behav-ioral health perspective; each of the models focuses on the patient and her interactions with physicians, health care systems or “public health,” and the testing companies as an interconnected web of health care provision. Those models triangulate regulation by focusing on interactions between physicians and patients by putting informed consent duties on the physicians; and be-tween patients and companies by putting quality assurance standards on the laboratories. At its most fundamental, however, the DTC genetic test compa-ny is a business selling a product (or service) to an individual as a consumer independent of other relationships. The company may encourage a consumer to speak with a health care provider, but the company does not sell its product in the context of the normal health care relationships. The company acts in a business relationship with the consumer. The business should thus be held to

173. Hum. Genetics Comm’n, A Common Framework of Principles for Direct-to-Consumer Genetic Testing Services 1 (2010), available at http://www.hgc.gov.uk/UploadDocs/DocPub/Document/ HGCPrinciplesforDTCgenetictests-final.pdf. 174. Id. at 2. 175. Id. at 6. 176. Id. at 7. 177. Id. at 9. 178. Id. at 12.

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business ethics standards, and if the product requires additional regulation be-cause the consumer cannot be adequately protected by ethical business deci-sions (as discussed below), then the government can step in with guidelines on sales and use.

“The core problem of reflection on ethics is that it invokes a philosophi-cal dilemma: how do we make judgments reconciling the right and the good?”179 For a business, no conflict between ethical actions and achievement of the firm’s goal—profit maximization—would arise if being virtuous coin-cided with an increase in the firm’s wealth; the dilemma occurs when the co-incidence of acting “ethically” and the profit maximization do not match.180 For a DTC genetic test company, this dilemma would occur when profits could be maximized by avoiding the expense of ensuring the test provides the most accurate results possible or supplying the consumer with access to a genetic counselor.181 Law, in the form of regulation, can change this dynamic by setting a bar that business decisions must meet if the ethical standard re-mains below that level. “Government regulation and legislation have been used more and more frequently, and now have become the favorite and usual means of reform.”182 Business could regulate itself, but, in the absence of self-reform, the public mandate has moved toward increased government con-trol.183

Part II of this Article will now discuss the two primary business ethics principles elucidated above—informed consent and quality assurance—in the context of DTC genetic tests and whether federal regulation is a necessary intervention. While socially responsible deliberation will generally not lead management to decisions different from those indicated by long-run profit considerations, federal regulation may be necessary when the market fails to police business decisions to produce results that align with ethical principles of the business.184

179. Jeffrey M. Lipshaw, Law as Rationalization: Getting Beyond Reason to Business Ethics, 37 U. TOL. L. REV. 959, 987 (2006). 180. Id. at 987-88. 181. See id. Part II Section A; see also id. Part II Section B. 182. RICHARD T. DEGEORGE, BUSINESS ETHICS 459 (3d ed., Macmillan Publishing Com-pany 1990). 183. Id. at 459. To be most effective, though, the code of business ethics must be adopted industry-wide; if adopted industry-wide, codes of ethics are, in theory, a viable alternative to government regulation. Norman E. Bowie, Business Codes of Ethics: Window Dressing or Legitimate Alternative to Government Regulation?, in ETHICAL THEORY AND BUSINESS 234, 235-36 (Tom L. Beauchamp & Norman E. Bowie eds., Prentice Hall, Inc. 1979). 184. Craig Ehrlich, Is Business Ethics Necessary?, 4 DEPAUL BUS. & COM. L.J. 55, 66-69 (2005). Ehrlich argues that good business strategy, not an ethical agenda, will drive corporations to make decisions that respond to the ethical demands of the marketplace. Id. at 67. Evidence suggests that a market for ethical corporate conduct is growing. Newberg, supra note 169, at 287. Whatever the root cause of the business manager’s decision, the marketplace does fail in some instances to produce an ethically-acceptable outcome. Ehrlich, supra note 184, at 69. This is where regulation can step in to fill the gap.

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A. Informed Consent

To respect the consumer and to avoid manipulation of him, a DTC ge-netic test company should supply information on the test and results that are targeted to the lay consumer before purchase or receipt of results. Like the fundamental rights model, this is an information-producing requirement. Un-like that model, however, the business ethics model does not separate the manufacturer from the ethical principle by placing the burden on physicians or health care providers. Instead, the business model requires the manufacturer, not the physician, to fully inform the consumer. Federal regulations, then, should step in only if the company is not able to fulfill this ethical obligation on its own. Business ethics mandates that companies supply information to consumers. The government should only depart from this baseline if it deems regulations necessary to provide adequate protection to the consumer.

A consumer has the ability to make an informed decision only when he understands the disclosure of all material information concerning the genetic test.185 As a result, the American College of Medical Genetics (“ACMG”) released a statement on DTC genetic testing that acknowledges the need for informed consent.186 As part of ACMG’s “minimum requirements” for any genetic testing, two requirements implicate informed consent.187 First, “the consumer should be fully informed regarding what the test can and cannot say about his or her health.”188 Second, ACMG states that a “knowledgeable pro-fessional should be involved in the process of ordering and interpreting a genetic test.”189 This requirement gives rise to two forms of informed decision making: the “process of ordering” implies pre-testing information, while the interpretation of a genetic test necessarily involves post-test information.

Pre-test education and counseling includes informed consent and is “composed of a careful explanation of the scientific aspects of genetic testing, addressing test sensitivity, specificity, possibility of indeterminate test results, actions the patient may take given a positive or negative test result (anticipa-tory guidance), and the cost of testing.”190 Genetic counseling conducted prior to testing explores the potential benefits, risks, and limitations of the test. Among other components, the genetic counselor should explain what infor-mation can be gleaned from a positive and a negative test result, including

185. BEAUCHAMP & CHILDRESS, supra note 150, at 120. 186. Am. College of Med. Genetics, ACMG Statement on Direct-to-Consumer Genetic Testing (2008), available at http://www.acmg.net/StaticContent/StaticPages/DTC_Statement.pdf [hereinafter ACMG Statement]. 187. Id. 188. Id. 189. Id. 190. Shelly Cummings, The Genetic Testing Process: How Much Counseling is Needed?, 18 J. CLINICAL ONCOLOGY 60s, 62s (2000).

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information on the type and magnitude of health risk associated with a posi-tive test, as well as the risk that remains despite a negative test.191

While information supplied by the DTC companies may include such relevant medical information, DTC marketing alone likely fails to adequately inform the consumer. Consumers generally cannot understand probabilistic figures, “and the risks and uncertainties associated with genetic information are especially challenging.”192 For example, “typical odds ratios found in ge-nome-wide association studies are less than 1.5,” meaning the presence of a particular gene increases the risk of a particular trait by only 50%.193 This may sound high, but, as one group of authors put it, a “50% increased risk may sound like a lot until you realize how low the starting odds usually are.”194 One genetic variant that increased the risk of coronary artery disease by 60% only raised the risk of disease from 1% to 1.6%.195 In addition, the results of a genetic test can be indefinite; for example, a person may test positive for a specific trait but lack a clinical phenotypic expression due to incomplete pene-trance, inconsistent expression, and environmental factors.196 The combined effects of all twenty genetic variants associated with adult height, for instance, explained only 3% of height variation.197 The complicated nature of genetic tests makes it essential that consumers involve professional genetic counselors or physicians before taking a genetic test. The consumer needs professional input to ensure adequate appraisal of the costs and benefits of genetic testing and to consider the many options available to the consumer. A genetics expert can help the consumer determine whether a genetic test should be performed, the risks involved in such testing, and how to interpret potential results of various genetic tests.

This involvement should also continue after the consumer receives the results of a genetic test. One post-test problem that can arise is a misunder-standing of the data. A misunderstanding could take the form of genetic de-terminism, “the idea that what is written in an individual’s genes is an inevita-ble and inescapable fate.”198 Genetic determinism could give people the incor-rect idea that the absence of a particular gene gives them “carte blanche,” so they need not make assiduous lifestyle choices.199 Alternatively, genetic deter-minism could lead people to believe a disease manifestation is inevitable, even

191. Id. 192. Sarah E. Gollust, Sara Chandros Hull & Benjamin S. Wilfond, Limitations of Direct-to-Consumer Advertising for Clinical Genetic Testing, 288 J. MED. AM. ASS’N 1762, 1763 (2002). 193. Magnus et al., supra note 24, at 2. 194. Id. 195. Id. 196. Gollust et al., supra note 192, at 1763. 197. Magnus et al., supra note 24, at 2. 198. Gabrielle Kohlmeier, The Risky Business of Lifestyle Genetic Testing: Protecting Against Harm-ful Disclosure of Genetic Information, 2007 UCLA J.L. & TECH. 5, ¶ 27 (2007). 199. Id.

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if it may never occur.200 For example, two healthy sisters in the United King-dom each recently opted for a double mastectomy after learning they had inherited the BRCA-2 gene, which increased their odds of developing breast cancer, a disease that claimed the lives of their mother and grandmother.201 The sisters may never have developed the deadly disease, but the presence of a genetic variant pushed the sisters to a prophylactic surgery.

The psychological harms caused by receiving information from a genetic test can include deflated self-image, anxiety, guilt, and perceived and actual social stigma.202 Most genetic tests offer only a probability of inheriting a dis-ease but do not provide a definitive determination as to whether an individual will develop that condition.203 “The interpretation of such results is often highly nuanced” and must be conducted in the correct context and in an un-derstandable fashion.204 “Feelings of guilt, loss, and doubt can arise if the con-sumer learns of a mutation that was passed on to other family members, de-cides to terminate a pregnancy, or chooses” prophylactic surgery.205 Lack of adequate post-test counseling by a health professional heightens the danger that individuals will be misled or misinterpret the results.206

Though many DTC genetic test companies currently offer counseling services, the potential for conflicts of interest—another general business eth-ics principle—should caution consumers from relying on such services or advise companies against offering them in-house. First, profit motives could reduce the motivation to emphasize a patient’s option not to take the genetic test.207 Home testing companies receive more money when the consumer elects to take a genetic test. While conflicts between clinical and financial mo-tivations are not unique to genetic testing, intermediate steps—such as insur-ance payments—present in other medical arenas, often temper the conflict by breaking the direct link between a medical professional’s recommendation and the financial impact on the patient making the decision.208 Those intermediate buffers are not yet present in DTC genetic testing, since insurance or specialist referrals are not involved. The company may be tempted to inappropriately weigh its own financial considerations over the consumer’s needs due to reli-

200. Id. 201. Sisters Both Have Double Mastectomies After Seeing Their Mother and Grandmother Die of Breast Cancer, DAILY MAIL, Sept. 1, 2010, available at http://www.dailymail.co.uk/health/article-1307935/Two-young-sisters-double-mastectomy-breast-cancer-claims-mother-gran-great-aunts.html. 202. Alexander van Voorhees, Note, Truth in Testing Laws: A Shot in the Arm For Designer Gene Tests, 16 HEALTH MATRIX 797, 804 (2006). 203. ACMG Statement, supra note 186. 204. Id. 205. NEIL F. SHARPE & RONALD F. CARTER, GENETIC TESTING: CARE, CONSENT, AND

LIABILITY 56 (Wiley-Liss 2006). 206. Kohlmeier, supra note 198, at 27. 207. Novick, supra note 12, at 637. 208. Id.

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ance on out-of-pocket expenditures by the consumer and lack of an ongoing relationship between company and consumer.209 Additionally, lack of pre-test counseling means the consumer must rely on the substance of the DTC com-pany’s supporting information to check for clinical validity.210 In that situa-tion, the company has an obvious conflict of interest: exaggerating the validity of the science will likely result in increased sales.

Proponents of increased government regulation for DTC genetic tests thus claim that consumers need federal regulation or oversight in order to understand the potential risks and benefits of taking a genetic test and to comprehend the complicated and often ambiguous results.211 The American Medical Association (“AMA”) summarizes the issue this way:

Consumers may obtain tests and make health decisions without un-derstanding the complex genetic information required to interpret re-sults . . . and they may be influenced by marketing campaigns de-signed to exploit fear and anxiety.212

For this reason, the AMA recommends that genetic testing be accom-plished only under the guidance of trained health professionals in the context of fully informed consent and comprehensive counseling before and after the test.213 Federally-mandated genetic counseling would then measure up with this statement and could assist consumers before a test is taken and guide patients in necessary post-test actions.

The DTC genetic test companies, conversely, argue that consumers should control their personal genetic information by choosing whether to visit a physician or counselor and decide for themselves if they require assistance in understanding the information. The policy of 23andMe states:

23andMe believes people have the right to access their personal ge-netic information. Genetic information is a fundamental element of a person’s body, identity and individuality . . . . We believe our custom-ers are capable of understanding the context of the information we provide them. We also think the benefits our customers accrue in as-sessing their genetic information outweigh the potential risks.214

The company has resisted FDA regulation in the past and stated, “[W]e believe that people have the right to know as much about their genes and their bodies as they choose.”215 As discussed above, the belief that consumers can

209. Id. 210. Drabiak-Syed, supra note 44, at 83. 211. See, e.g., Magnus et al., supra note 24. 212. AM. MED. ASS’N, REPORT 7 OF THE BOARD OF TRUSTEES: DIRECT-TO-CONSUMER

ADVERTISING AND PROVISION OF GENETIC TESTING, available at http://www.ama-assn.org/ama1/pub/upload/mm/471/bot7.doc. 213. Id. 214. Policy Forum, 23ANDME, available at https://www.23andme.com/about/policy/ (last visited Oct. 23, 2011). 215. Andrew Pollack, F.D.A. Faults Companies on Unapproved Genetic Tests, N.Y. TIMES, June 12, 2010, at B2. This resistance, however, may be crumbling. In recent congressional testimony,

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understand the information given by genetic tests is suspect. Furthermore, the statement that genetic information is a fundamental element of a person only begs the question whether regulation is necessary. It is a valid proposition to state that genetic information is inherently “us,” and, therefore, should be made available to the consumer; but it does not follow that access to that in-formation fulfills the ethical obligation of autonomy. Knowledge is not always power; a consumer who does not understand the genetic information cannot give informed consent to the genetic test or to follow-up procedures based on the results of that test. An accurate test result means little if not properly ex-plained to the consumer in the context of treatment, further testing, or life-style recommendations. Consumers may have a right to their genetic infor-mation, but regulations can ensure that the right is properly and ethically exer-cised.216

Companies may also have a free speech claim if the government at-tempts to regulate any truthful and nonmisleading advertising of genetic tests.217 The First Amendment states that “Congress shall make no law . . .

a few DTC genetic test companies stated that they welcomed federal oversight of their busi-ness. See, e.g., Direct-to-Consumer Genetic Testing and the Consequences to the Public Health: Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 111th Cong. (2010) (statement of Ashley C. Gould, Gen. Counsel, 23andMe, Inc.). This newfound ac-ceptance of federal oversight, though, may come with the caveat that the testing not take place under the current FDA regulatory structure. Id. 216. See Lawrence O. Gostin, General Justifications for Public Health Regulation, 121 PUB. HEALTH 829 (2007). The idea of government regulation that requires an individual to make an informed choice about her purchases smacks of paternalism, defined as “the protection of the health or safety of competent individuals irrespective of their own expressed wants and de-sires.” Id. At one extreme, John Stuart Mill opined that the “only purpose for which power can be rightfully exercised over any member of the civilised [sic] community, against his will, is to prevent harm to others.” JOHN STUART MILL, ON LIBERTY 28 (Gertrude Himmelfarb ed., Pen-guin Classics 1985) (1859). Put another way, Mill’s principle asserts that “your freedom to swing your arm ends where my nose begins.” RONALD BAYER & DAN E. BEAUCHAMP, PUBLIC

HEALTH ETHICS: THEORY, POLICY, AND PRACTICE 86 (Ronald Bayer et al. eds., Oxford Univer-sity Press 2007). The most controversial justification for paternalistic interventions, therefore, is “[r]isk to self,” since the conduct appears to affect only, or at least primarily, the person con-cerned. Gostin, supra at 831. Indeed, genetic information is “crucial to personhood” and has much to do with an individual’s self and future and with decisions regarding that future. Jacque-lyn Ann K. Kegley, A New Bioethics Framework for Facilitating Better Decision-Making About Genetic Information, PUBLIC HEALTH POLICY AND ETHICS 91, 92 (Michael Boylan ed., Kluwer Academic Publishers 2004). The case against paternalism rests on the assumption that individuals act in a self-interested manner, so they will weigh the risks and benefits themselves. Gostin, supra at 831. For example, a motorcyclist declines to wear a helmet not because he does not know of the risk but because he must value freedom above safety. Id. A few defenses of paternalistic interventions can be made, though. First, genetics and genetic information implicate more than just the individual; for instance, genetic disease affects family members as well. Kegley, supra at 92. Second, an individual faces cognitive limitations when presented with complex scientific information, so he cannot actually arrive at a fully informed decision in this situation. Gostin, supra at 832. 217. For an extensive analysis of this claim, see Javitt et al., supra note 14.

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abridging the freedom of speech.”218 The Supreme Court, however, has cate-gorically excluded certain classes of speech from First Amendment protection, including obscenity, fighting words, incitement, and defamation.219 Many also believed that speech relating to commercial transactions and activities—so-called “commercial speech”—was also excluded from protection.220 The Su-preme Court, though, has protected commercial speech under a four-part test articulated in Central Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n of New York.221 First, the court must determine whether the expression concerns law-ful activity and is not misleading.222 If it satisfies both requirements, then it qualifies for First Amendment protection. Second, the court must ask whether the government interest in regulating the speech is substantial.223 Third, the court must determine whether the regulation directly advances the govern-ment interest asserted and, fourth, whether the regulation is not more restric-tive than necessary to serve that interest.224 The government must show a “fit between the legislature’s ends and the means chosen to accomplish those ends . . . a means narrowly tailored to achieve the desired objective.”225 In other words, a court uses intermediate scrutiny in commercial speech cases.

Assuming the speech is truthful and not misleading, the government must assert an important interest to justify any restriction. Protection of the public’s health and protection against many of the potential harms discussed in this Section would almost certainly qualify.226 A case would therefore turn on the third and fourth prongs of Central Hudson—the government must show that regulation would directly provide for the asserted interest and that the regulation is narrowly tailored to achieve that end. A restriction on commer-cial speech would likely fail because the government would be hard pressed to show how the restriction would advance the interest asserted or that a re-striction is a necessary maneuver.227 Requiring certain disclosures, however, may be a more winnable argument.228 In that case, the government may be able to require information disclosure through regulation without violating the commercial free speech doctrine.

218. U.S. CONST. amend. I. 219. Javitt et al., supra note 14, at 288. 220. Id. at 289. 221. 447 U.S. 557 (1980) (cited by Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001)). 222. Id. at 566. 223. Id. 224. Id. 225. Lorillard, 533 U.S. at 556 (quoting Florida Bar v. Went For It, Inc., 515 U.S. 618, 632 (1995)). 226. Javitt et al., supra note 14, at 300. 227. Id. at 300-01. 228. Id. at 301.

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B. Quality Assurance

The ethical norm of quality assurance places an additional obligation on DTC genetic test companies—the duty to ensure test validity, both analytic and clinical. For this reason:

[T]he laboratory performing the test must be able to get the right an-swer as to whether a specific genetic variant is present or absent—so-called analytic validity. The genetic variant being analyzed also must correlate with a specific disease or condition in the patient (i.e., a phenotype) or with heightened risk of disease. This is called clinical validity.229

Analytic validity, then, describes the accuracy of the test while clinical va-lidity denotes the usefulness of the test for the consumer. A patient can only benefit from the test if it accurately pinpoints a genetic variation and that ge-netic variation actually correlates with what it purports to signify. For instance, the two British sisters introduced in Section A, who elected for a prophylactic double mastectomy could only benefit from a DTC genetic test if the test accurately located the BRCA-2 gene in the women and if the BRCA-2 gene actually indicated a higher propensity to develop breast cancer.

Lack of either type of validity can harm the patient in a variety of ways. For example, physicians who rely on the test may not have accurate infor-mation on which to make treatment decisions.230 Suppose the two British sisters had relied on a test that lacked analytic validity. They may carry the BRCA-2 gene and could be at greater risk for breast cancer, but they would not take adequate steps to avoid the disease if the test gave a false negative. Suppose, instead, that the test concluded that the sisters had a BRCA-2 gene, but that gene had little scientific significance in the development of cancerous cells. A double mastectomy, in that case, would be a drastic course of action in response to a test with little to no clinical validity.

Entities in favor of more regulation can point out that CLIA and the FDA may be able to enforce analytic and clinical validity. CLIA regulations enforce analytic validity through checks on the laboratory processes.231 The government can use CLIA and implement a genetic testing specialty to uphold quality requirements and proficiency standards to ensure accuracy of the test-ing procedure.232 The SACGHS believes that CLIA can ensure accuracy with-out a genetic specialty; however, as long as CMS uses genetic experts to train laboratory inspectors to understand the technologies, processes, and proce-dures utilized by genetic testing laboratories.233 If that is true, then current

229. Hogarth et al., supra note 3, at 169. 230. Hamburg & Collins, supra note 21, at 303. 231. SACGHS Oversight Report, supra note 127, at 4. For an argument that CLIA could en-sure clinical validity, see supra note 138. 232. Robertson, supra note 97, at 237. 233. SACGHS Oversight Report, supra note 127, at 111.

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regulations would be enough to provide for analytic validity so long as CMS correctly trains personnel in genetic technologies. The SACGHS does recom-mend that the FDA address all laboratory genetic tests in “a manner that takes advantage of its current experience” in evaluating and regulating laboratory tests.234 Although law and regulations do not define clinical validity as a pa-rameter to be reviewed by the FDA, assessments of safety and effectiveness are generally tied to an assessment of the clinical performance of the test or device.235

Diagnostic manufacturers, though, have claimed that strict regulatory oversight could dampen innovation.236 Alternate mechanisms to regulation, then, could include the tort system and the free market as adequate checks on quality. Tort remedies operate indirectly on manufacturers; the threat of liabil-ity, rather than direct supervision, induces the company to improve safety.237 Tort suits brought under state law allow for personalized, fact-specific adjudi-cation of a quality complaint.238 The manufacturer could be held strictly liable for products “defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reason-able alternative design . . . and the omission of the alternative design renders the product not reasonably safe”239 or when the product is “in a defective condition unreasonably dangerous to the user or consumer” and harm oc-curs.240 Furthermore, opponents of regulation could argue free market forc-es—such as competition—could increase quality. If consumers respond to increases in quality, a competitive market could increase quality of the product on its own without government interference.241 Presumably, consumers will only purchase genetic tests from the manufacturers with the highest quality standards.

Several problems, however, hinder the forcefulness of these arguments. First, the free market mechanisms generally break down when information asymmetries exist; that is, regulation may be necessary when the seller knows

234. Id. at 112. 235. Id. at 97. 236. Caruso, supra note 22. Some product manufacturers, however, have come to realize that regulation may be preferable to tort liability. See Jeffrey J. Rachlinski, Regulating in Foresight Versus Judging Liability in Hindsight: The Case of Tobacco, 33 GA. L. REV. 813 (1999). 237. Deepthy Kishore, Test At Your Own Risk: Your Genetic Report Card and the Direct-to-Consumer Duty to Secure Informed Consent, 59 EMORY L.J. 1553, 1572 (2010). 238. Id. at 1573. 239. Randy J. Prebula, Note, The Promise of Personalized Medicine: Regulatory Controls and Tort Influences in the Context of Personalized Risks and Benefits, 26 J. CONTEMP. HEALTH L. & POL’Y 343, 364-65 (quoting RESTATEMENT (THIRD) OF TORTS § 2(b) (2008)). 240. Prebula, supra note 239, at 365 (quoting RESTATEMENT (SECOND) OF TORTS § 402(a) (1965)). 241. Rajiv D. Banker, Inder Khosla & Kingshuk K. Sinha, Quality and Competition, 44 MGMT. SCI. 1179, 1191 (1998).

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the quality of the product but the buyer does not.242 Informational asymme-tries abound in the DTC genetic test market. As discussed in Section A, con-sumers will likely find it difficult to assess the utility of a genetic test due to its probabilistic nature and the long-term development of many genetic diseas-es.243 Consequently, free market forces may not weed out risky, ineffective, economically harmful, or fraudulent products, a conclusion realized in other over-the-counter health interventions.244 Second, like the medical model, tort relief only provides compensation to victims after the harm has occurred and only if a jury finds for the victim. The consumer, therefore, would be depend-ent on a group of lay persons who must muddle through the science of genet-ic testing, but are likely not qualified to do so.245 In addition, some consumers may not sue, and others may not have the resources to demonstrate a compa-ny’s liability.246 Problems of proof further complicate the issue since clinical relevance of many genetic variants remains unclear, and only a small propor-tion of the genetic contribution to disease or condition has been identified.247

III. A PLAN TO REGULATE DIRECT-TO-CONSUMER GENETIC TESTS

The business ethics model demonstrates two areas in which government oversight may be necessary to adequately protect the consumer: information production and quality assurance. Consumers cannot rely on DTC genetic test companies to provide adequate information or understand the information given to them in order to make a knowledgeable decision before or after tak-ing a genetic test. Consumers likewise cannot depend on DTC genetic test companies to ensure their product achieves analytic or clinical validity. Gov-ernment oversight, then, should cover these gaps.

To fulfill the information producing principle and to avoid the pitfalls discussed in Part II, federal regulations should focus on two key objections: first, a trained healthcare provider or genetic counselor should be involved in the purchase of a genetic test and in the provision of the results; and second, the healthcare professional should be independent of the DTC genetic test company to avoid a conflict of interest. To accomplish this end, the federal government could create an independent registry of genetic counselors trained to give complex genetic information to laypersons. Regulations could then require a consumer to speak with a listed professional before purchasing a test

242. Hayne E. Leland, Quacks, Lemons, and Licensing: A Theory of Minimum Quality Standards, 87 J. POL. ECON. 1328, 1329 (1979). 243. See supra notes 192-97 and accompanying text. 244. Maxwell J. Mehlman et al., Anti-Aging Medicine: Can Consumers be Better Protected?, 44 GERONTOLOGIST 304, 305 (2004). 245. A 2004 study found that half of U.S. adults lack the skills needed to evaluate the risks and benefits of health-related technologies. SACGHS Oversight Report, supra note 127, at 25. 246. Rachlinski, supra note 236, at 814. 247. SACGHS Oversight Report, supra note 127, at 24.

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and make the professional available after the results have been revealed by the DTC genetic test company.

The regulations, though, must balance the need to provide information with the desire to maintain patient autonomy. To achieve this equilibrium, regulations could require the consumer to meet with a genetics counselor to discuss genetic testing, including the science behind the tests, the ramifications of potential results, and whether certain identified conditions can be treated or mitigated under the present state of medical interventions. It would be an information-producing meeting, not a meeting that persuades the consumer to take a genetic test or not to purchase one. The professional would not serve as a gatekeeper to a genetic test, allowing some consumers through but not oth-ers; rather, the genetic counselor would act as a “human label” for DTC ge-netic tests—providing consumers with necessary information, helping con-sumers understand the possible risks and potential benefits of the genetic testing service, and answering all questions the consumer may have.248

Once a consumer has met with the listed professional, the professional can then enter the consumer’s information into a web-based system to be accessed by the DTC genetic test company for verification when the consum-er contacts the test company. The professional would also be available for post-results counseling if the consumer desires to meet confidentially with the genetic counselor. This meeting would be independent of the consumer’s usual healthcare provider in order to allay fears of adverse use of the results by the consumer’s personal physician or insurance company. To maintain inde-pendence and avoid a conflict of interest, a DTC genetic test company must not be able to sponsor or promote a specific professional, and a listed profes-sional must not be allowed to receive a kickback or quid pro quo for recom-mending a specific service. The system, though, could be funded by a user fee paid by the companies to the federal agency in charge of the registry.

CLIA can be used to ensure both analytic and clinical validity without requiring two agencies, such as CMS and the FDA, to serve as watchdogs for laboratory processes. While CMS has never enforced clinical validity standards under CLIA, the regulations do appear to provide for clinical accuracy. For example, CLIA requires the laboratory director and technical supervisor to ensure that selected test methodologies can provide the quality of results re-quired for patient care.249 Implicit in this command is the responsibility of the laboratory director to utilize medically relevant test methodologies that have an effective clinical purpose; if they are not clinically purposeful, those meth-odologies cannot be said to be “required for patient care.”250 A congressional amendment to CLIA, such as the one proposed by the late Senator Kennedy

248. Again, this idea appears loaded with paternalism and may be offensive to the inde-pendent consumer. As discussed in supra note 216, however, third-party concerns and cognitive limitations may justify such an intrusive intervention. 249. 42 C.F.R. § 493.1445(e)(3)(i) (2003). 250. SACGHS Oversight Report, supra note 127, at 94.

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in 2007,251 could mandate CLIA to develop a genetic specialty that includes standards for analytic and clinical validity. Only one agency would have to train specialists to oversee the DTC genetic test industry, and only one spe-cialist would have to inspect the laboratory and its product to ensure compli-ance with the regulations.

CLIA can better accomplish the goal of quality assurance than the FDCA because the FDCA’s quality mechanisms may be too broad in this situation. The business ethics model demonstrates that regulation may be necessary to assure analytic and clinical validity, but it is not clear that the FDCA’s purpose of ensuring the “safety and effectiveness” of a medical de-vice must be invoked for DTC genetic tests.252 DTC genetic tests more closely resemble the laboratory services typically covered by CLIA than the medical devices regulated by the FDA. Unlike, for instance, a replacement heart valve, the consumer never handles the genetic test kit. If a heart valve fails after im-plantation, the patient would be physically affected by the malfunction. Con-versely, the consumer of a DTC genetic test would be adversely affected in two situations. First, lack of information on the test and its results or a failure to understand the science could lead to uninformed and potentially harmful reactions by the consumer. Information production, though, more adequately corrects for this problem than any warning label mandated by the FDA, as discussed above in Part II. Second, an erroneous test result—either a false positive or a false negative—could result in useless or harmful preventative measures by the consumer. Quality assurance in the form of increased analytic and clinical validity helps remedy this problem, and CLIA is already in the laboratories to monitor quality problems. CLIA, if given clear instructions from Congress through the creation of a genetic specialty, can provide the needed regulatory check on quality.

IV. CONCLUSION

TIME magazine recognized the promise of DTC genetic tests in 2008 by naming the product its Invention of the Year, but the problems that accom-pany such testing have led to calls for increased regulation of the industry. Using a business ethics model to evaluate current auto-regulation by DTC genetic test companies, it is apparent that government regulation may be nec-essary to ensure consumers obtain appropriate information before and after purchasing a test and receiving its results. In addition, tweaking CLIA can help improve quality by assuring the tests offer analytic and clinical validity.

251. See supra note 111 and accompanying text. 252. See supra notes 53-54 and accompanying text.