Drug Approvals Are Up In 2011

The Food & Drug Administration approved 35 new medicines in fiscal 2011, which ended on Sept. 30. The agency is using the result, the second-highest total in the past 10 years, to argue for renewal of the Prescription Drug User Fee Act (PDUFA), which authorizes the agency to collect user fees from industry to fund the drug approval process.

FDA released the results on Nov. 3 with fanfare that included a press conference and a 28-page report. In addition to the high number of approvals, the agency pointed out important advances for patients, including two new treatments for hepatitis C, a drug for late-stage prostate cancer, and the first new drug for Hodgkin’s lymphoma in 30 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 compared the time needed to review 57 drugs 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 funds collected under PDUFA, which expires on Sept. 30, 2012. Some congressional Republicans are wary of changes that will allow the agency to amass more regulatory powers (C&EN, Oct. 17, page 44).

John C. Lechleiter, CEO of the drugmaker Eli Lilly & Co., voiced his support for reauthorization of the law in a recent speech. 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.