Web Date: November 7, 2011
Near Record Drug Approvals In 2011
The Food & Drug Administration approved 35 new medicines in fiscal 2011, which ended on Sept. 30, the second highest total in the past decade. The agency is using the good results to argue for renewal of the Prescription Drug User Fee Act (PDUFA), which collects user fees from industry to fund the drug approval process.
FDA released the results last week with fanfare that included a press conference and a 28-page report. In addition to the high number of approvals—surpassed only by the 37 drugs approved in fiscal 2009—the agency pointed to several important advances for patients. They include two new treatments for hepatitis C, a drug for late-stage prostate cancer, the first new drug for Hodgkin’s lymphoma in 30 years, and the first new lupus treatment in 50 years.
“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA,” said FDA Commissioner Margaret A. Hamburg. “We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments.”
Seeking to silence critics who complain about the lengthy approval process, the agency pointed to a review of 57 drugs that were approved in both the U.S. and the European Union between 2006 and 2010. FDA’s median review time for priority drugs was six months, less than half the time required in the EU. For standard drugs, FDA’s median time for approval was 13 months, versus the EU’s 14.7 months. Moreover, 24 of the 35 approvals in fiscal 2011 occurred in the U.S. before any other country, the agency said.
FDA attributed its performance to expedited approval authorities, flexibility in clinical trial requirements, and resources collected under PDUFA, which expires on Sept. 30, 2012. Some Congressional Republicans are concerned that the agency will amass more regulatory powers if it is renewed (C&EN, Oct. 17, page 44).
Commenting on the report, David E. Wheadon, senior vice president for scientific and regulatory affairs at Pharmaceutical Research & Manufacturers of America, an association of major drugmakers, said the results underscore the importance of expediently approving the user fee act.
John Lechleiter, CEO of the drugmaker Eli Lilly & Co., also voiced his support for reauthorization of the law in a speech last week. At the same time, Lechleiter called on FDA to change its culture from one focused disproportionately on risk to one that seeks to balance risk and benefit.
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