The 111th U.S. Congress Tackles Healthcare Reform and the Pharmaceutical Industry

Abstract

The stakes have never been higher or more serious for the pharmaceutical industry - a perfect storm of legislation is moving through Washington, D.C., to address patent reform, healthcare reform, drug importation, authorized generics, biosimilars, and much more. Does the 111th U.S. Congress have the political will to fundamentally change the status quo? One certainty in these uncertain times is that legislation that goes off the table this year is more than likely to resurface next year and the years after that. In this report, we discuss several of the legislative bills of 2009 and the potential impact they could have on the biopharmaceutical industry.

• Alex M. Brill, CEO of Matrix Global Advisors and a research fellow at the American Enterprise Institute, determined that a seven-year data exclusivity period was sufficient to ensure adequate return on investment for a portfolio of biologics. Why is data exclusivity a life or death issue for the biopharma industry? Why does the CEO of the Generic Pharmaceutical Association say that proposals for biosimilars data exclusivity by the biopharma industry are excessive? Why does the general counsel of Eli Lilly argue that if the biopharma industry relies solely on patent terms for protection that the industry will have a survivability issue?
• John C. Lechleiter, Ph.D., Eli Lilly' s CEO, said that under certain situations comparative effectiveness research will stop personalized medicine in its tracks. How could this happen? What aspects of this research does pharma support? Are industry stakeholders trying to co-opt the legislative process and mold it accordingly?
• Kevin E. Noonan, J.D., Ph.D., a partner in a Chicago intellectual property firm, says that the real driver for patent reform has come down to the issue of damages. What started the movement to reform the U.S. patent system? Who is pushing for reform? Why have perceptions changed over the last decade? What is likely to happen if patent reform falls off the radar screen this year?
• The late Senator Edward M. Kennedy (D-MA) has said that healthcare reform is the “cause of my life” and that Congress can adjust and improve any healthcare reform program that is enacted for years to come. What is the status of healthcare reform in the United States? Why is a bill likely to be passed this year? What are the major issues?

• Authorized generics and pay-for-delay deals: Reverse payment settlements, Hatch-Waxman Act, gamesmanship, FDA Drug Safety bill, Federal Trade Commission, Cephalon, Provigil, Teva Pharmaceutical Industries, Mylan, Barr Pharmaceuticals, Ranbaxy Laboratories, antitrust laws.
• Biosimilars: Size of biologics markets, data exclusivity, Henry G. Grabowski analysis, John E. Calfee, American Enterprise Institute, Matrix Global Advisors, Alex M. Brill, Generic Pharmaceutical Association, Federal Trade Commission' s input, biologic-biosimilar market dynamics, interchangeability, reference product, mechanism of action.
• Comparative effectiveness research: Institute of Medicine report, 1,278 potential projects, 100 priority topics, conclusions in the aggregate, Partnership to Improve Patient Care, clinical value, patient health outcomes, coverage and payment decisions, Comparative Effectiveness Research Institute, Patient-Centered Outcomes Research Institute.
• Drug importation: Pharmacoeconomics, risks of drug safety, MAPLight.org.
• Healthcare reform: Obama' s eight key principles, glide path to reform, need for reform, Congressional Budget Office cost projections, individual mandate, public plan, healthcare cost curve.
• Patent reform: National Academies, Federal Trade Commission, damages, crossroads, fundamentally different approaches, non-obviousness standard, consistency, postgrant opposition procedure, best mode, harmonization, Coalition for 21st Century Patent Reform, choice of venue, apportionment of damages, objective recklessness, interlocutory appeals.
• Privacy of personal health information: BBC World News America/The Harris Poll, electronic medical records, Coalition for Patient Privacy, The Healthcare Leadership Council, Confidentiality Coalition, notifications of a breach of protected health information, penalties for violating personal privacy, New Hampshire' s Prescription Information Law, prescriber-identifiable data.