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New Study Shows that FDA Approves Cancer Drugs Faster Than its European Counterpart

New Study Shows that FDA Approves Cancer Drugs Faster Than its European Counterpart

For Immediate Release – June 16,2011
Contact: Ryan Hohman
202.944.6708 or

New Study Shows that FDA Approves Cancer Drugs Faster Than its European Counterpart

Contrary to Repeated Assertions New Oncology Medicines Are Consistently Available First in the United States

WASHINGTON, DC- Friends of Cancer Research (Friends) today announced the release of a study, published in Health Affairs, showing that approval rates of oncology drug products are higher in the United States than in Europe. The study examined the approval rates of new oncology drugs that were submitted to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) between 2003 and 2010.

The study found that:

· In this time period, FDA approved 32 new anti-cancer drugs while EMA approved only 26.

· FDA not only approved more new cancer drugs than did the EMA, it approved these drugs more quickly: of 23 drugs approved by both agencies, the median time from marketing submission to FDA approval was 182 days vs. EMA approval of 350 days.

· Furthermore, drug companies typically submitted their clinical findings to the FDA prior to submitting these findings to the EMA.

· All 23 of the drugs approved by both agencies in this time period were available to patients in the United States before becoming available to patients in Europe. 

The study can be accessed in full HERE

This study will be discussed today at a briefing on Capitol Hill Exploring the Future of Innovation and Global Competitiveness. The briefing today is open to the public: 2:00pm- 3:00pm EST, House Budget Committee Hearing Room, 210 Cannon House Office Building. Keynote by Congresswoman Diana DeGette (D-CO), discussion with Dr. Janet Woodcock, Director, CDER, FDA and other experts.

The FDA has been portrayed by many critics as slow and inefficient compared the EMA. While this criticism is particularly strong in the field of cancer, where severely ill patients have few therapeutic options, the new study reveals that the FDA is approving novel anti-cancer drugs in a timely fashion and, in fact, is actually exceeding the EMA.

While the FDA should be praised for this, it is important to note that strong public support and additional Congressional appropriations are needed for the FDA to continue this trend and to improve its scientific foundation, so that all therapeutic classes of drugs can benefit from efficient and high-quality FDA review. Furthermore, these findings reinforce the need for strong post-marketing surveillance, so that these medicines can continue to be made available to patients in need without compromising their safety.  


Friends of Cancer Research (Friends) is a cancer research think tank and advocacy organization based in Washington, DC. Friends is a leader in developing partnerships and advocating for policies that will get treatments and therapies to patients in the safest and quickest way possible. Working with federal health agencies, congressional leadership, academic research centers and private sector industry, Friends continues to create innovative educational, policy, and scientific approaches to improve health outcomes and cancer care.