Press Release

Embargoed Until Contact

June 16, 2011
7:01 AM EST

Sue Ducat
Director of Communications
(301) 841-9962


New Study Finds FDA Approval Process For Cancer Drugs Faster Than The European Medicines Agency (EMA)


Bethesda, MD --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 appearing in Health Affairs compared new oncology drugs between 2003 and 2010 and found that for the median time for approval in the US by the FDA was six months, compared to nearly twice that length of time for the EMA.


Despite Criticism Of The FDA Review Process, New Cancer Drugs Reach Patients Sooner In The United States Than In Europe
By Samantha A. Roberts, Jeff D. Allen, and Ellen V. Sigal


Roberts, Allen, and Sigal are affiliated with Friends of Cancer Research, in Washington, D.C. Roberts is a science policy analyst; Allen is the group's executive director; and Sigal is its chairperson and founder.


In this study, the authors identified thirty-five new oncology drugs that were approved by either the FDA or the EMA between 2003 and 2010. The FDA approved thirty-two of these products, twenty of them within 184 days. In contrast, the EMA approved twenty-six of these products, and the median 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 the authors. They note that a factor in shortening FDA review times over the past two decades has been the Prescription Drug User Fee Act 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 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."


There will be a related briefing on June 16 from 2:00 to 3:00 p.m. on Capitol Hill, titled "Realizing the Return on Investment of Biomedical Research Science and Progress at the Food and Drug Administration." Speakers will include coauthor Ellen Sigal and Janet Woodcock of the FDA .
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About Health Affairs

Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears each month in print, with additional Web First papers published weekly at You can also find the journal on Facebook and Twitter and download Narrative Matters on iTunes. Address inquiries to Sue Ducat at (301) 841-9962 or