The U.S. should implement policies that will double the output of new, innovative medicines for important unmet medical needs within 15 years, according to a report released yesterday by the President's Council of Advisors on Science and Technology. The report on "Propelling Innovation in Drug Discovery, Development, and Evaluation" said this goal could be met through increasing funding for basic, translational and regulatory science and creating a broad-based partnership bringing together government, industry, academia and other stakeholders to improve the discovery, development and evaluation of new medicines.
The report recommends creating a new "special medical use" pathway to approve drugs for narrow populations. It also recommends strengthening FDA's postmarketing surveillance capacity by appropriating $40 million per year for the agency's Sentinel electronic safety surveillance system. PCAST said FDA should explore the creation of an adaptive, or progressive, approval system, but it concluded that legislation creating an adaptive approval system "would be premature at this time."