June 16th, 2011
The US Food and Drug Administration (FDA) is often criticized as inefficient compared to its European counterpart, the European Medicines Agency (EMA), particularly in the field of oncology. However, a new study published online today by Health Affairs suggests otherwise: For new oncology drugs between 2003 and 2010, the median time for FDA approval was six months, compared to nearly as long for the EMA.
Researchers from Friends of Cancer Research in Washington, D.C., identified 35 new oncology drugs that were approved by either the FDA or the EMA between 2003 and 2010. The FDA approved 32 of these products, with a median approval time of 182 days. In contrast, the EMA approved only 26 of these products, and the median approval time was 350 days.
“The FDA is often accused of being slow to approve oncology drugs. However, critics have not provided specifics, and our study plainly shows that such assertions are unwarranted,” write lead author Samatha Roberts and colleagues.
The study will be discussed at a Capitol Hill briefing this afternoon, June 16, from 2:00 to 3:00 p.m. Speakers will include study coauthor Ellen Sigal and Janet Woodcock of the FDA. Coverage of the study is also available through a number of media outlets, including Reuters, NBC News Business (CNBC), the Wall Street Journal, the Chicago Tribune, and the Baltimore Sun.
The study notes that a factor in shortening FDA review times over the past two decades has been the Prescription Drug User Fee Act (PDUFA) of 1992. This legislation, which is reauthorized every five years, gives the FDA the authority to collect fees from companies producing certain drugs and biological products, with the funds used to improve approval times and safety standards.
With the next PDUFA reauthorization expected in 2012, the authors say that “continued financial support, in the form of user fees and increased appropriations, will be crucial for the agency to keep pace with current scientific discovery–and to maintain and enhance the agency’s critical role of bringing new medicines from the stages of discovery into the clinic and ultimately improving the lives of patients.”
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