Microsoft Word - Final for LuLu Vol. 14 Issue 1 Final 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 http://doi.org/10.18060/3911.0033 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, 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 A. The Legislation 1. Hatch-Waxman Act The Hatch-Waxman Act--25 Years Later: Keeping the Pharmaceutical Scales Balanced Id Id Id 2. Patient Protection and Affordable Care Act (“ACA”)(“ObamaCare”) a. The pharmaceutical tax all New Taxes for Pharmaceutical and Device Manufacturers/Importers/Distributors Id Id supra see also Annual Fee Imposed on Prescription Drug Manufacturers and Importers Annual Fee See generally New Taxes for Pharmaceutical and Device Manufacturers/Importers/Distributors Id. Id. Id. 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 supra See id. Marketing and Direct-to-Consumer Advertising (“DTCA”) of Pharmaceuticals, See generally Open Payments, Id. Id. See generally . Id Id See generally id . 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 B. Patent and Antitrust Laws See generally Pharmaceutical Industry Pharmaceutical Industry supra Pharmaceutical 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” supra Id. C. Generic Pharmaceutical Company Issues Prescriptions For Change: The Hatch-Waxman Act And New Legislation To Increase The Availability Of Generic Drugs To Consumers supra Drug 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 D. Increased Marketing Expenditures Detailing How a Cabal Keeps Generics Scarce supra see also, , supra There Ain’t No Such Thing as a Free Lunch: A Look at State Disclosure Laws and the Effect on Pharmaceutical Company Marketing see 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. Sorrell v. IMS Health See generally Health Care Costs: A Primer Pharmaceutical Detailing Definition supra The 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. https://doi.org/10.1080/01947648.2012.714328 Sorrell v. IMS Health, Id. Id. New Reps, New Rap: The Counter-Detailers supra Id. Prescription Drugs: Academic Detailing See id. supra Id. See generally Resistance to Affordable Care Act Continues Nationwide supra Sales Innovation and Metric Report, 2014, E. Increasing Costs of Research & Development Id. supra Drug Development R&D: New Transaction Structures Id. supra supra supra supra Medicines: Costs in Context supra F. Increased Medicare Coverage Id. More than 430 New Medicines in Development for Top Chronic Diseases Affecting Older Americans 2015 Profile: Biopharmaceutical Research Industry Who Funds Biomedical Research? PhRMA Member Companies Invested $51.2 Billion in R&D in 2014 Id. Pharmaceutical Industry supra supra supra Id. Id. 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 supra Id. Id. Fewer Employers to Offer Retiree Prescription Drug Plans: Survey . Id. Id. Id. supra A. Off-Label Prescription Drug Use Id. Id. supra Off-Label Use, Prescription, and Marketing of FDA-Approved Drugs: An Assessment of Legislative and Regulatory Policy see also Liability and Off-Label Prescriptions Id. Off-Label Drug Promotion and the First Amendment Off-Label Use Promotion is Protected Free Speech supra 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. Actavis typically Id. see, e.g. supra Pharmaceutical Antitrust: Delayed Generic Entry Cases Id. supra 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 See generally The Emergence of ‘Venture Philanthropy’ Raises New Tax Issues see also Foundation 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. See See A. Potential Abuses See Cystic Fibrosis: Charity and Industry Partner for Profit supra see also The Private Foundation supra The 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 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. supra Id. supra Id. B. Potential Benefits and Increase Innovation Through Nonprofit Funding of Research and Development Id. Id. Id. Id Id. See generally id. See generally supra See generally Companies in North America See supra Nonprofit Drug Companies http://doi.org/10.1377/hlthaff.24.6.1684 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 supra Id. Id. See generally supra supra 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 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 supra Id. 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. 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 generic brand-name See Definition of a Private Operating Foundation supra Taking You From Idea to IND and Beyond See id. supra 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 TransCelerate “If you want to be incrementally better: Be competitive. If you want to be exponentially better: Be cooperative.” Private Foundations