Final for LuLu Vol. 14 Issue 1 Final · 2017-03-20 · ,1',$1$ +($/7+ /$: 5(9,(: 9RO 2. Patient...
Transcript of Final for LuLu Vol. 14 Issue 1 Final · 2017-03-20 · ,1',$1$ +($/7+ /$: 5(9,(: 9RO 2. Patient...
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A. The Issue: Increasing Pharmaceutical Prices
B. Why Prescription Affordability is Important
C. “PhRMA’s” Contributions to the Pricing Problem
D. General Outline
A. The Legislation
1. Hatch-Waxman Act
2. Patient Protection and Affordable Care Act (“ACA”) (“ObamaCare”)
B. The Judiciary (FTC v. Actavis)
A. Introduction
B. Patent and Antitrust Laws
C. Generic Pharmaceutical Company Issues
D. Increased Marketing Expenditures
1. Detailing
E. Increasing Costs of Research & Development
F. Increased Medicare Coverage
A. Off-Label Prescription Drug Use
B. Delaying Generic Entry
Potential Abuses
1. Pharmaceutical Companies Creating Their Own Philanthropies Then
Funding The
2. Limiting the Field of Ideas to the Ideas Heavily Funded by Corporations
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Potential Benefits
1. Increase Innovation Through Nonprofit Funding of Research and
Development
2. Economic Repurposing of Drug
Example: Cystic Fibrosis Foundation Collaboration with Vertex
Pharmaceuticals
A. Federal Tax Re-evaluation for Pharmaceutical Representatives
B. Use of Modified Venture Philanthropy
1. Utilizing Private Nonprofit Foundations with “Program-Support” Grants
2. Creating Own Private, Operating, Foundations
A. The Issue: Increasing Pharmaceutical Prices
Here’s Exactly How the United States Spends $2.9 Trillion on Health Care
Id.Prescription Drugs to Lead Trend of Health Care Price Increases,
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B. Why Prescription Affordability is Important
C. “PhRMA’s” Contributions to the Pricing Problem
D. General Outline
Health Premium Cost Trends Steady For 2015, But Drug Costs Expected To Rise
See generally Study Shows About 48% of Americans Take at Least One Prescription Drug
See generally Baby Boomers
Just How Many Baby Boomers Are There?
Nearly 7 in 10 Americans Take Prescription Drugs, Mayo Clinic, Olmsted Medical Center Find
The Good News on FDA and ANDAs,
Pharmaceutical Spending available at
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A. The Legislation
1. Hatch-Waxman Act
The Hatch-Waxman Act--25 Years Later: Keeping the Pharmaceutical Scales Balanced
IdIdId
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2. Patient Protection and Affordable Care Act (“ACA”)(“ObamaCare”)
a. The pharmaceutical tax
all
New Taxes for Pharmaceutical and Device Manufacturers/Importers/Distributors
IdId
supra see also Annual
Fee Imposed on Prescription Drug Manufacturers and ImportersAnnual Fee
See generally New Taxes for Pharmaceutical and Device Manufacturers/Importers/Distributors
Id.Id.Id.
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b. National physician payment transparency program (“Open Payments”)
c. Congressional funding of research & development
Id.see also Annual
Fee Imposed on Prescription Drug Manufacturers and Importers
supraSee id.Marketing and Direct-to-Consumer Advertising (“DTCA”) of Pharmaceuticals,
See generally Open Payments,
Id. Id.See generally
.IdIdSee generally id .
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B. The Judiciary (FTC v. Actavis)
FTC v. Actavis Actavis
FTC v. Actavis
A. Introduction
Big Pharma’s Favorite Prescription: Higher Prices, see also
Pharmaceutical Industry Gets High Off of Fat Profits,
Id.Competition Ahead? The Legal Landscape For Reverse Payment
Settlements After Federal Trade Commission v. Actavis, Inc.
Id.
Id.See supra
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B. Patent and Antitrust Laws
See generally Pharmaceutical Industry
Pharmaceutical Industry
supraPharmaceutical Industry supra
Pharmaceutical Antitrust: Delayed Generic Entry Cases
Frequently Asked Questions on Patents and Exclusivity
Pharmaceutical Corporations and Medical Research
Drug Patent Expirations and the “Patent Cliff”
supraId.
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C. Generic Pharmaceutical Company Issues
Prescriptions For Change: The Hatch-Waxman Act And New Legislation To Increase The Availability Of Generic Drugs To Consumers
supraDrug Prices Defy Gravity, Doubling or Dozens of Products,
The Industry
Id.
Be Wary of Stratospheric Increases in Generic Drug Prices,
Id.Id.
Expose Reveals Why We No Longer Trust All Generic Drugs
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D. Increased Marketing Expenditures
Detailing
How a Cabal Keeps Generics Scarce
supra see also, , supraThere Ain’t No Such Thing as a Free Lunch: A Look at State Disclosure
Laws and the Effect on Pharmaceutical Company Marketingsee also Big Bad Pharma: An Ethical Analysis of Physician-Directed and Consumer-Directed Marketing Tactics
The Impact of Direct-to-Consumer Advertising
Big Bad Pharma: An Ethical Analysis of Physician-Directed and Consumer-Directed Marketing Tactics
Id.
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Sorrell v. IMS Health
See generally Health Care Costs: A Primer
Pharmaceutical Detailing Definition
supraThe Pharma Marketing Glossary
Persuading the Prescribers: Pharmaceutical Industry Marketing and its Influence on Physicians and Patients
Pharmaceutical Detailing Is Not For Everyone: Side Effects May Include Sub-Optimal Prescribing Decisions, Compromised Patient Health, And Increased Prescription Drug Spending
supra
Regulating Pharmaceutical Marketing After Sorrell v. IMS Health Inc.
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Sorrell v. IMS Health,
Id.Id.
New Reps, New Rap: The Counter-Detailers
supraId.
Prescription Drugs: Academic Detailing
See id.
supraId.See generally Resistance to Affordable Care Act Continues Nationwide
supraSales Innovation and Metric Report, 2014,
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E. Increasing Costs of Research & Development
Id.supra
Drug Development R&D: New Transaction Structures
Id.supra
suprasupra
supraMedicines: Costs in Context
supra
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F. Increased Medicare Coverage
Id.More than 430 New Medicines in Development for Top Chronic Diseases
Affecting Older Americans2015 Profile: Biopharmaceutical Research Industry
Who Funds Biomedical Research?
PhRMA Member Companies Invested $51.2 Billion in R&D in 2014
Id.Pharmaceutical Industry supra
suprasupra
Id.Id.
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Medicare’s Rising Cost – and the Need for Reform
The Facts on Medicare and Health Spending and Financing
CMS Releases Prescriber Data for the First Time
How is Medicare Funded?supra
supraId.Id.
Fewer Employers to Offer Retiree Prescription Drug Plans: Survey
.Id.Id.Id.
supra
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A. Off-Label Prescription Drug Use
Id.Id.
supraOff-Label Use, Prescription, and Marketing of FDA-Approved Drugs: An
Assessment of Legislative and Regulatory Policy see alsoLiability and Off-Label Prescriptions
Id.Off-Label Drug Promotion and the First Amendment
Off-Label Use Promotion is Protected Free Speech
supra
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B. Delaying Generic Entry
Id.Off-Label Prescribing
supra
Id.See id.Id.Medicines: Cost in Context
New York Attorney General Examining Whether Turing Restricted Drug Access
Id.Economic Basics: Supply and Demand
supra .Id.
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Actavistypically
Id. see, e.g.
supra
Pharmaceutical Antitrust: Delayed Generic Entry Cases
Id.
supra
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See generally Abuse of the FDA Citizen Petition Process: Ripe for Antitrust Challenge?
Id.FTC Files Amicus Brief Explaining that Pharmaceutical “Product Hopping” Can Violate
the Antitrust Laws
Id.Antitrust Scrutiny of Pharmaceutical “Product Hopping ”
Id.Venture Capital Philanthropy: The IRS and Treasury Hold The No-Cost Key
To The Growth Of Self-Sufficient Nonprofits January 2002
Id.supra
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See generally The Emergence of ‘Venture Philanthropy’ Raises New Tax Issues
see alsoFoundation Grants
supra Venture Philanthropy: The Changing Landscape
‘Venture Philanthropy’ is the New Buzz in Business
Who’s Afraid of Philanthrocapitalism?,
The Private Foundation
Id.Id.
SeeSee
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A. Potential Abuses
See Cystic Fibrosis: Charity and Industry Partner for Profit
supra see also The Private Foundation supraThe Private Foundation supra
Loans
see also
See generally supra
Finding A Cure: Incentivizing Partnerships Between Disease Advocacy Groups and Academic and Commercial Researchers
See The Role of Nonprofit Institutes in Pharmaceutical Development
Advanced R&D By Venture Philanthropy
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1. Pharmaceutical Companies Creating Their Own Philanthropies Then Funding Them
2. Limiting the Field of Ideas to the Ideas Heavily Funded by Corporations
Stop Subsidizing Big Pharma
Id.See Establishing a Nonprofit Organization
walkthrough
The Private Foundation supra Id.
supraId.
supraId.
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B. Potential Benefits
and
Increase Innovation Through Nonprofit Funding of Research and Development
Id.Id.Id.IdId.See generally id. See generally supraSee generally Companies in North America
See supraNonprofit Drug Companies
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2. Economic Repurposing of Drugs
Id.See generally supra
supra See generally The Cost Of Creating A New Drug Now $5 Billion, Pushing
Big Pharma To Change
supra See generally Definition of a Private Operating Foundation
supraId.Id.See generally supra
supra
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C. Example: Cystic Fibrosis Foundation Collaboration with Vertex Pharmaceuticals
PhRMA Statement on Healthcare Reform Coalition
Id.supra
Repurposing Drugs
Patent Tips for Small Pharma Companies
Repurposing – Finding New Uses for Old (and Patented) Drugs: Bridging the “Valley of Death,” to Translate Academic Research Into New Medicine
supra Orphan Products: Hope for People With Rare Diseases
see also supra
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A. Federal Tax Re-evaluation for Pharmaceutical Representatives
supra Id.Id.Id.
Kalydeco: A Price Too High To Pay
See id.See supra
supra See supraId.
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Id.Dep’t of the Treasury, Cat. No. 11081L, Travel, Entertainment, Gift, and Car
Expenses
See Physician Payment Sunshine: Some Pharmaceutical Companies Reduced Meal Payments to Health Care Providers
Id.
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1. Why Regulate Pharmaceutical Promotion?
B. Use of Modified Venture Philanthropy
1. Utilizing Private Nonprofit Foundations with “Program-Support” Grants
Code on Interactions with Healthcare Professionals
Id.Id. .Id.
Regulation of Pharmaceutical Promotion: Why Does Regulation Matter?
Id.Poll: Americans’ No. 1 health priority is keeping critical drugs
affordable for patients,
See generally supra see generally
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genericbrand-name
See Definition of a Private Operating Foundation supraTaking You From Idea to IND and Beyond
See id.supra
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Creating Own Private, Operating, Foundations
TransCelerate BioPharma, Inc.,
TransCelerate BioPharma
The Orphan Drug: What’s Right With It
supra Foundations: Overview
Ten Pharmaceutical Companies Unite to Accelerate Development of New Medicines
Id.supra
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TransCelerate
“If you want to be incrementally better: Be competitive. If you want to be exponentially better: Be cooperative.”
Private Foundations