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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

PCAST Issues Recommendations for Drug Development Pipeline; FDA Seeks Comments on Patient-Centered Risk Benefit Assessment

September 28, 2012—The President’s Council of Advisors on Science and Technology Policy (PCAST) Sept. 25 recommended that the U.S. set a goal of doubling output of innovative new medicines that meet critical public health needs over the next 10 to 15 years and continue steps to improve drug safety.  The recommendations and supporting analysis were released in a report titled Propelling Innovation in Drug Discovery, Development, and Evaluation.

To increase the rate of discovery and development of new drugs, PCAST calls for better methodologies and tools for translating basic biological insights into validated therapeutic targets and leads, and for pharmaceutical developers and regulators to incorporate new efficiencies into clinical trials of candidate medicines.  The council recommends establishing a public-private “Partnership to Accelerate Therapeutics,” to help identify and plan collaborative actions that would speed drug development.  The partnership would include broad stakeholder representation, including from academia, physician societies and pharmacists, industry, patient advocacy groups, health providers, and government. 

Several recommendations focus on improving the regulatory approval process, primarily at the Food and Drug Administration (FDA), and on establishing new partnerships across the biomedical research “eco-system.”  PCAST specifically notes that the FDA requires new methods to approve drugs rapidly for narrow populations for which there is a favorable benefit-risk balance, while protecting the broader population from drugs that have an unknown or unfavorable benefit-risk balance.  The council also calls for strengthening post-marketing surveillance, developing tools to generate further evidence of drug benefits and risks, and communicating that information back to the public.

On the related topic of improving assessment of benefit and risk, the FDA Sept. 24 issued two Federal Register notices seeking public comments on patient-focused drug development.  The more extensive notice seeks public comment on developing patient-centered risk assessment in several areas of disease.  The notice also seeks comments on establishing a context to assess such risk/benefit, which may vary among patients with the disease or diagnosis.  Comments to FDA responding to the notice are due Nov. 1. 

The second notice announced that FDA would hold public consultation meetings on this same topic, the first of which will be held in Silver Spring, Md., on Oct. 10.  Members of the public who wish to participate in the consultation meeting should notify FDA by Oct. 3. 

PCAST is a standing White House council comprised of external scientists. It is currently co-chaired by the president’s science advisor, John P. Holdren, Ph.D., and Eric Lander, Ph.D., president of the Broad Institute of Harvard and MIT.

Contact:

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org