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Minority Health and Health Disparities - Progress and Policies: An FDA Perspective

From Cataloging Health Disparities to Creating Health Equity:

Effective Models to Equalize Outcomes

March 13, 2015

Overview

• Big Picture View of FDA

• Policy and Minority Health

–Health Disparities- beyond cataloging to impacting clinical outcomes

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History- Why Regulate? Food /Drug Laws typically enacted from tragedy • Fatal transmission of tetanus through antitoxin – 1902 Biologics Control Act

• Food scandals of ~1900 -Harvey Wiley and the “Poison Squad” 1906 Pure Food and Drug Act – created food/drug regulation – allow action on safety

• Sulfanilamide with antifreeze killing over 100, DNP and blindness: 1938 FD and C Act – allowed premarket safety review and an action not to approve

• Thalidomide (tragedy averted) and Kefauver-Harris Amendments: pre-market safety and efficacy review and approval (1962)

• Food and Drug Administration Amendments Act (FDAAA) of 2007, Section 901 of the Federal Food, Drug, and Cosmetic Act and new safety authorities (Vioxx, Ketek, etc)

• FDA Safety and Innovation Act 2012 – Sections 907 and 1138; supply chain; patient involvement; breakthrough therapies

• Drug Quality and Security Act of 2013 - pharmacy compounding crisis

• On the horizon: Precision Medicine, 21st Century Cures….. 6

FDA Mission: Protect and Promote Public Health Protect

– Assure safety, effectiveness and security of human and veterinary drugs, vaccines, other biological products, medical devices, food, cosmetics, radiation-emitting devices

Promote – Help speed innovations that make needed products

available, and where possible, more effective, safer and affordable

– Provide accurate, science based information to maximize product benefits and reduce risks

– Enhance preparedness by facilitating the development and availability of Public Health Emergency Medical Countermeasures

• Regulate tobacco products

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FDA’s Scope is Vast, Complex, and Evolving

• FDA is responsible for over $2 trillion in medical products, food, cosmetics, dietary supplements and tobacco.

• FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers.

• The agency has approximately15,700 full-time employees located around the world.

• FY 2014 budget was $4.38 billion.

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FDA’s Scope is Vast, Complex, and Evolving

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• Every American pays about $8 per year for the vast array of protections and services FDA provides.

• FDA ensures that the food that Americans serve their families every day is safe

• Confidence that the medical products ranging from toothpaste to cancer drugs, will provide the expected health benefits.

Globalization Realities FDA-regulated products originate from more than:

− 150 countries − 130,000 importers − 300,000 foreign facilities

Overall number of FDA-regulated shipments at over 300 U.S. ports has quadrupled over ten years - Last year, nearly 28 million shipments

Distinction between domestic and imported products is largely obsolete

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Globalization and Regulated Products Food

− 10-15% of all food consumed by U.S. households is imported − ~ 50% of fresh fruits and 20% of fresh vegetables imported − 80% of seafood eaten domestically is from outside the U.S. − Food imports increased 10% per year from 2005-2011

Devices − At least 50% of all medical devices used in the U.S. are imported − Medical device imports grew at over 10% per year from 2005-2011

Drugs − At least 40% of drugs on U.S. shelves come from overseas − 80% of API manufacturers are located outside the U.S.

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FDA Review Centers Product review and product quality, safety and manufacturing monitoring are carried out by scientists in FDA medical product Centers

– Center for Biologics Evaluation and Research (CBER):

• Vaccines, blood and related products, cellular, tissue and gene therapies, living organisms intended as therapeutics

– Center for Devices and Radiologic Health (CDRH)

• Medical devices and diagnostics, and products that give off radiation, dental devices

– Center for Drug Evaluation and Research (CDER)

• Human drugs (prescription, over-the-counter, generic, biosimilar), not dietary supplements (unless they make disease treatment claims)

FDA Medical Product Related Activities • New product review and pre-market approval

– Proactive interactions during review process

– Written reviews (pre-clinical, clinical, manufacturing data, facilities) and decisions

• Monitoring

– Manufacturing quality and safety

– Safe handling

– Adverse events/new risks/populations

• Communication to patients and providers

• Enforcement/Compliance

• Research targeted to safety, efficacy, quality

FDA Review Centers: continued

• Center for Food Safety and Applied Nutrition (CFSAN)

– Foods, except meat and poultry products, which are regulated by USDA; food additives, labeling

– Dietary supplements; infant formula; cosmetics

– Regulation is primarily focused on safety

– New laws, Food Safety Modernization Act, provide authority for preventative and risk based controls on food production and action to limit outbreaks

• Center for Veterinary Medicine (CVM)

– Veterinary drugs (not biologics); animal feeds

• Center for Tobacco Products (CTP)- since 2009

What does FDA not do?

• Advertising (excluding drugs and medical devices), alcohol, consumer products (unless radiation emitting), illicit drugs, health insurance, meat and poultry, pesticides, restaurants, grocery stores, water

What does FDA not regulate?

• Regulate medical practice, services, or pricing

Who? Major Disciplines Engaged in Medical Product Review and Monitoring

• Administrative and policy staff

• Researchers

• Reviewers – Clinical

– Product quality

– Engineering and physics

– Pharm-tox

– Clinical pharmacology

– Biometrics

– Regulatory Project Management

– Clinical Microbiology

– Quality Microbiology

– Medical errors

– Manufacturing science and inspections

– Epidemiology

– Risk management

– Investigatory and enforcement

– Advertising

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FDA Faces Many Challenges

• Rapid scientific breakthroughs and emerging technologies resulting in novel products and raising unique testing and safety issues

• New and evolving public health threats

• Surveillance of products for issues in real world use

• Globalization of public health, science, manufacturing and supply chains

• Providing accurate and useful consumer information in age of information overload from multiple sources

Policy and Minority Health

Health Disparities- beyond cataloging to impacting clinical

outcomes

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30th Anniversary US Health and Human Services (HHS) 1985

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“…Landmark effort in analyzing and synthesizing the present state of knowledge of the major factors that contribute to the health status of Blacks, Hispanics, Asian/Pacific Islanders, and Native Americans. It represents the first time the Department of Health and Human Services (DHHS) has consolidated minority health issues into one report.”

HHS Secretary Margaret Heckler released the Secretary's Task Force on Black and Minority Health Report

Historical Overview • 1990—The Office of Research on Minority Health (ORMH) was

established by the NIH Director. • 1997- President Clinton’s Initiative on Race was established with the

goal to eliminate racial/ethnic disparities in health by 2010 as part of “Healthy People”

• 2000-first real legislation focusing on the reduction of health disparities was passed by Congress, creating the National Center for Minority Health and Health Disparities within NIH and authorized the Agency for Healthcare Research and Quality to measure progress on the reduction of disparities on an ongoing basis.

• 2003 - Institute of Medicine (IOM) released the landmark report, Unequal Treatment: Confronting Racial/Ethnic Disparities in Health Care

• March 2010 Affordable Care Act- Section 10334 mandated creation of OMH across all HHS divisions: also advanced NIH Center to an Institute (NIMHD) with funding authority

Affordable Care Act of 2010: Minority Health

• Elevation of the Office of Minority Health to the Office of the Secretary

• Establishment of individual Offices of Minority Health for HHS Agencies

• Elevation of the National Center on Minority Health and Health Disparities to an NIH institute

• Requires that an activities report be submitted to Congress not later than one year after enactment, and biennially thereafter

• Section 4302- Understanding Health Disparities: Focus on Data Collection and Analysis

– OMB standards at a minimum for race and ethnicity measures

• Section 1557: non-discrimination

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Koh, H et al, Am J of Public Health, American Journal of Public Health: April 2010, Vol. 100, No. S1: S72–S80

“Translating Research Evidence Into Practice to Reduce Health Disparities: A Social Determinants Approach”

HHS Action Plan to Reduce Racial and Ethnic Health Disparities- April 2011

Outlines goals and actions HHS agencies will take to reduce health disparities among racial and ethnic minorities

I. Transform health care

II. Strengthen the nation’s Health and Human Services infrastructure and workforce

III. Advance the health, safety, and well-being of the American people

IV. Advance scientific knowledge and innovation

V. Increase the efficiency, transparency, and accountability of HHS programs

FDA Safety and Innovation Act (FDASIA) of 2012 Section 907- Collection, Analysis, and Availability of Demographic Subgroup Data Section 1138 -Ensuring Adequate Information Regarding Pharmaceuticals for All Populations, Particularly Underrepresented Subpopulations, Including Racial Subgroups

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FDASIA Section 907 and 1138 History

• FDA Safety and Innovation Act of 2012- Final legislation reauthorizing FDA user fees (essential for Agency operations)

Requirements for an initial public report on inclusion data from applications

Subsequent action plan to address deficiencies

American Heart Association, WomenHeart, and Society for Women’s

Health Research lobbied Congress for legislation requiring FDA to

publicly report data on the inclusion and analysis of women in FDA

applications

Resulting Legislation: Heart for Women’s Act (HEART)

Sen. Debbie Stabenow (D-MI) and Rep. Lois Capps (D-CA)

Provision added to include reporting of a race and ethnicity

Sen. Benjamin Cardin (D-MD)

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Section 1138 – FDA Response After review of communication activities across FDA’s medical product centers and offices as well as HHS and FDA initiatives concerning plain language, language access, health literacy, FDA identified important opportunities, including the following:

• Creating targeted outreach to consumers and health care practitioners serving underrepresented patient subpopulations

• Developing an FDA-specific “language access” plan to address the needs of people with limited English proficiency

• Advancing efforts to include underrepresented subpopulations in FDA’s new Patient Network and Health Professional Network

• Continuing research into health literacy and FDA safety messaging

• Increasing the use of social media platforms to support the above activities and improve awareness among underrepresented subpopulations and racial subgroups about important safety information for FDA-regulated medical products

http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM359890.pdf

FDA Safety and Innovation Act of 2012 Section 907

– Report on inclusion and analysis of demographic subgroups which posted August 2013

– Issue an Action plan to address findings in the report which posted August 2014

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http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDr

ugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FD

ASIA/ucm389100.htm

Section 907 Action Plan

Three overarching priorities with 27 specific actions:

•Priority One: Improve the completeness and quality of demographic subgroup data collection, reporting and analysis (Quality)

•Priority Two: Identify barriers to subgroup enrollment in clinical trials and employ strategies to encourage greater participation (Participation)

•Priority Three: Make demographic subgroup data more available and transparent (Transparency)

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Example of Action and Status Update

Drug Trials Snapshot - provide consumers information about the sex, age, race and ethnicity of clinical participants of recently approved drugs.

– In addition to information about who participates in the trial, each Snapshot also includes information on how the study was designed, results of the efficacy and safety studies and, if known, differences in efficacy and side effects among sex, race and age

– Fall 2014, six examples posted that represent approvals for drugs that treat a broad range of diseases. These drugs were approved over a two month period in 2014.

– Docket was opened for Stakeholder Feedback on the content, format and overall usability of the first six Snapshots.

Beginning in 2015, FDA intends to post a Snapshot for every NME and original biologic approved.

http://www.fda.gov/Drugs/InformationOnDrugs/ucm412998.htm

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Race: The number of non-white patients was limited; therefore, differences in response between white and non-white patients could not be determined. http://www.fda.gov/Drugs/InformationOnDrugs/ucm435307.htm

COSENTYX is used to treat moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skin.

Cataloguing Health Disparities (Compared to Non-Hispanic Caucasians)

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African Americans Asian Americans Hispanics

60% higher rates of preterm births (17% vs 10.8%)

Lowest rates of cervical and breast cancer screenings

Twice as likely to have diabetes

Twice the infant mortality Vietnamese Americans have 5X higher rate of cervical cancer

Twice as likely to have cervical cancer

40% more likely to die from heart disease

South Asians 7X more likely to have type 2 diabetes

Puerto Rican children are 3X more likely to have asthma

30% more likely to die from cancer (all types)

Higher stomach cancer rates among men

1/5 Hispanics do not seek medical care due to language barrier

http://www.cdc.gov/minorityhealth/CHDIReport.html http://www.ahrq.gov/research/findings/nhqrdr/nhqr13/2013nhqr.pdf

• What is the state of knowledge of the disease and the proposed indication?

• Are there relevant differences in prevalence by demographic subgroups?

• Are there differences in population characteristics by demographic subgroup- what is impact on inclusion/exclusion factors in trials? – Genomic differences? Safety concerns? – Any concerns in regard to exposure-response relationship? – Is the course of the disease sufficiently similar? – Concomitant diseases and therapies ? – Is the response to treatment sufficiently similar? – Clinical Management and differences in standard of care?

Medical Product Development- Targeting Clinical Outcomes Health Disparities and Trial Design Considerations

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FDA Policy for Clinical Database and Inclusion for new Drugs

“The database submitted in a marketing application should reflect usage in a diverse racial population, one reflective of the likely patient mix postmarketing, for potential differences in response to become apparent” (Good Review Practice for INDs Dec 2013)

– Inclusion and exclusion criteria • Co-morbidities, BMI, concomitant meds

– Global : Who are the subjects in the trials? • Geographic/Ancestry/Living conditions/Culture/Differences in

standards of medical care outside the U.S. which may impact outcomes

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Representative Valid ?

Health Disparities in the Age of Genomics

• Important new insights into the causes of and susceptibility to disease (e.g., Hep C, TB) and adverse reactions to drugs – Rotimi, and Jorde, NEJM, Vol 363;16,Oct 14, 2010, pp 1151-1558.

• For personalized medicine to be meaningful and applicable to global populations, need to know how both common and rare genetic variants found in different parts of the world influence health and drug response

– Importance of increasing ethnic and racial diversity among participants in genomic research

• Ramos, Callier and Rotimi, Personalized Medicine, 2012;Vol 9 (8), 839-847.

• 1000 Genomes Project Consortium- Nature, Nov 2012, Vol 491, pp 56-65.

FDA Office of Minority Health

Mission The Office of Minority Health advances FDA’s regulatory mission in addressing the reduction of racial and ethnic health disparities and in achieving the highest standard of health for all

Goal 1- To improve and strengthen regulatory science informing the research and evaluation of sub-population data associations with race and ethnicity.

Goal 2- To strengthen FDA capacity to address minority health and health disparities across the Agency

Goal 3- To promote effective communication and the dissemination of information to the public, particularly underserved, vulnerable populations.

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FDA Office of the

Commissioner Office of Chief

Scientist Office of Minority

Health

HHS

Assistant Secretary for Minority Health

OMH Office Directors HHS Disparities Council

Federal Interagency Health Equity Team

Minority Serving Institutions

Communication

and Outreach (FDASIA Section 1138)

Health Professional Organizations

Patient/Disease Advocacy Social Media

Inclusion in Clinical Trials in

Applications submitted to FDA (FDASIA Section 907)

Research Collaborations in

Regulatory Science and Health Disparities

HHS Low English

Proficiency Plan-

Language Access

(ACA Section 1557)

FDA Plain Language Health Literacy

Risk Communication

What We Do

OMH Outreach and Communication The OMH Outreach and Communications Program has two purposes:

• To improve FDA communication with underserved communities and to partner with external stakeholders to identify and reduce health disparities

– Implementing the Language Access Plan (2014)—an initiative to identify the needs of people with limited English proficiency and to provide meaningful access to FDA information important to health.

– Stakeholder engagement- working with professional organizations, academic institutions, and advocacy groups, to collaborate with FDA.

– OMH promotes diversity in the public health workforce and supports minority health research and community outreach:

• Participates in FDA ORISE Fellowship and Pharmacy Intern Program

• Working with FDA centers to assist Minority Serving Institutions (MSIs)

• Participating in local community health fair and promoting interest in STEM education

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OMH Research and Collaborations Promotes and funds, as resources allow, projects that:

– Study medical conditions that disproportionately affect minorities; and/or analyze data that can answer FDA concerns

• For example, a project could analyze race and treatment data from clinical trials to determine if a medicine is equally safe and effective for a specific race/ethnic group; aim to increase the quantity of, and improve the quality of data on minorities .

– Program also supports lectures, meetings, and conferences on minority health and health disparities.

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http://www.fda.gov/ForConsumers/ByAudience/MinorityHealth/default.htm

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“One of the core tenets of rigorous biomedical research, as well as a guiding principle of the FDA’s goal to meet the health needs of patients across the demographic spectrum, is the importance of encouraging diversity in clinical trials. When a more diverse population participates in clinical trials, we increase the potential to know more about the extent to which different subgroups—males and females, young and old, people of various racial and ethnic backgrounds, and patients with differing comorbid diseases and conditions—might respond to a medical product. And when subgroup data are analyzed, we have available more information about the product that can be communicated to the public. The result is greater assurance in the safety and effectiveness of the medical products used by a diverse population.”

Commissioner Margaret Hamburg August 2014

Policy Engagement

• March 25th- OMH sponsored webinar: How to Comment to FDA Dockets-Making Your Voice Heard

• FDA Advisory Committee Meetings and Membership – Advisory Committee Calendar

http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

– Applying for Membership – https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm

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Thank you Connect with us - FDA Office of Minority

Health

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