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Pharma and the Feds: Key Government Activities and How They Affect the Biopharmaceutical Industry
Decision Resources, Inc., Sep 2008, Pages: 44
This is a critical time in U.S. history for examination of the delivery of healthcare services. Some 47 million people in the United States lack healthcare coverage; the country spends $2.2 trillion annually on healthcare; the United States ranks 37th in terms of healthcare outcomes. Healthcare is thus in the spotlight among the population, the legislators who represent the population, and candidates in this year’s presidential elections. Certain healthcare issues—because they represent a confl uence of the pending elections, recent legislative activity, and volatile trends affecting the U.S. healthcare marketplace—have near-term and/or powerful consequences for biopharma and thus pose an opportunity for biopharma players to act now so as to best navigate change. In the current landscape, there are opportunities to tap, threats to weather, and waves to ride.
Get the Answers You Need to Shape Your Strategy
- The November elections are fast approaching. McCain? Obama? What is the outlook for biopharma if either is elected?
- Spectrum has followed developments in personalized medicine with ever-growing interest. How does recent legislation fuel the move toward personalized medicine? What are the presidential candidates’ positions on this issue?
- Cost issues that threaten the traditional biopharma business model are on the table and are being served upwith particular enthusiasm given the general economic situation. Is it likely that legislation approving importation and biosimilars will be enacted? What will the impact be?
- As cost-consciousness moves to the fore, the question of funding innovation ascends with it. What do stakeholders say? What does legislation affecting privacy of genetic and other patient data mean for innovation? What is the outlook for stem cell research? For clinical trials?
- Patient safety, scrutiny of messages to consumers, and personal security in the health IT arena are priority issues for the government. What steps are being taken by the government to protect the public in these areas? Which legislative activities will address these issues, and how?
Scope
- Presidential elections: positions of the candidates relevant to biopharma and select legislation; timeframe for change.
- Issues to watch: health information technology, clinical trials, affordable medications, genetic information, biosimilars, and generics.
- Recently approved legislation: GINA, FDAAA, and Medicare.
- Pending legislation: The Pharmaceutical Market Access Act. The Wired for Health Quality Act. The Healthcare Enterprise Integration Act. The PRO(TECH)T Act. The ACCESS Act. The Stem Cell Research Enhancement Act of 2007. The HOPE Act of 2007. Biologics Price Competition and
Innovation Act of 2007.
- Expert Commentary: The impact of REMS on the value of a product in the pharmaceutical industry is discussed in a commentary by Covance’s Jeffrey Stoddard, M.D., VP, Medical and Scientifi c Affairs, Risk Management and Postmarketing Programs, and Edgar H. Adams, Sc.D., Executive
Director, Epidemiology.
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