Should FDA Stand for Fast Drug Approvals?

This article published with permission from The Burrill Report.

The biopharmaceutical industry has increasingly criticized the U.S. Food and Drug Administration for being too slow to approve new drugs. In fact, companies have said that they are turning to Europe and other markets as a place to bring new drugs and devices to market first because of regulatory uncertainty and growing risk aversion at the agency. But a new report challenges that perception, at least when it comes to cancer drugs.

The study, published in Health Affairs, looked at cancer drugs approved by the FDA and the European Medicines Agency between 2003 and 2010. It found that during that period the two agencies approved a total of 35 cancer drugs, with the FDA approving 32 of these products and the EMA approving 26. For the FDA, the median time of review for approved drugs was 182 days. Of the 32 cancer drugs it approved, the FDA approved 20 of those products within 184 days. Three of the drugs took more than a year to approve. By contrast, the EMA took a median time of 350 days to review the 26 cancer drugs it approved.

The European regulator acted faster than the FDA on only three of the drugs. However, for all of the 23 drugs approved by both agencies, they were available to patients in the United States before they were available to patients in Europe.

The authors only considered the period of time from the filing of an application to approval. They say they did not take into account difficulties drug developers may have encountered trying to communicate with the agencies prior to submission or in planning or conducting clinical trials.

“Contrary to repeated public assertions, we found that new oncology medicines are consistently available in the United States before they are in Europe, and they are more likely to be approved by the FDA than by the EMA,” write the study’s authors, all of whom are associated with the Friends of Cancer Research, a Washington, D.C.-based research and advocacy group. “Moreover, the median time for approval in the United States was just six months.”

The authors say the greater speed with which the FDA approved these drugs is not surprising. It reflects policies intended to provide faster reviews of drugs with greater therapeutic potential. They also say that the speed with which the FDA reviews drugs has improved as a result of the Prescription Drug User Fee Act. First approved in 1992, the law allowed the agency to collect fees from industry for the review of products. Known as PDUFA, the act is up for reauthorization in September 2012.

Despite the findings, the authors of the study say innovative trial designs and development pathways are needed to translate advances in basic science.

Copyright 2011 Burrill & Company. For more life sciences news and information, visit http://www.burrillreport.com.