Drug approval isn't a race between the U.S. and the E.U.

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Friday, February 4, 2011; 9:04 PM

In his Jan. 24 op-ed, "Finding a strategy for growth," Fareed Zakaria missed the mark regarding the speed of drug approvals in the United States and Europe. The facts show that the Food and Drug Administration's review times are somewhat shorter and that approval of new drugs generally occurs sooner in the United States, compared with Europe.

The FDA compared marketing approval of 57 novel drugs approved by both FDA and European Union regulators between 2006 and 2010. Of these, 43 were approved first in the United States and 14 were approved first by the E.U. Twenty-seven of these 57 drugs were FDA-designated priority review drugs that provide a therapeutic advance, and all but three of the 27 were approved first by FDA. The median time from marketing submission to FDA approval was 183 days for priority review products, and 396 days for standard review products. In the E.U., those times were 403 days and 449 days, respectively.

The review and approval of new drugs is not a race between FDA and EU regulators, with whom we collaborate and whom we see as colleagues. But we do operate under different laws and procedures. Finally, we note that apart from the FDA's regulatory climate, there are many reasons why industry chooses to work overseas, including reduced labor and production costs.

Margaret A. Hamburg, Silver Spring

The writer is commissioner of the Food and Drug Administration.


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