View Full Version : Study: US clears drugs faster than Europe, Canada

05-16-2012, 09:06 PM

WASHINGTON (AP) Researchers say the U.S. approved more new medicines in less time than Europe and Canada in the last decade, challenging long-standing criticisms that the Food and Drug Administration lags behind its peers in clearing important new drugs.

Between 2001 and 2010, the FDA's typical review of a new drug was about 15 percent faster than those by the European Medicines Agency and Health Canada, its counterparts abroad, according to a study published Wednesday by the New England Journal of Medicine. The analysis by researchers at Yale and the Mayo Clinic is the first to compare the FDA's recent drug review performance to similar agencies around the world.

Criticism that the FDA is too slow on drug approvals is a perennial theme for the pharmaceutical industry, which spends more than $50 billion annually to develop new drugs. The complaint has resurfaced in the past year as the industry renegotiates the fees it must pay the FDA to review new drug applications a program which is reauthorized by Congress every five years.

The study authors address this issue directly, defending the agency's performance.

"Our findings contradict recent criticisms of the speed of review by the FDA and lead to questions about whether the speed of the review process is justified as an emphasis ... particularly since the FDA continues to outpace its European and Canadian peers," the authors state.

The median time for drug reviews by the FDA was 322 days, or about 10 and a half months. That was 45 to 70 days ahead of Europe and Canada, which typically completed their drug reviews after 12 and 13 months, respectively. Over the same 10-year time frame, the FDA reviewed 225 drug applications, 40 more than Europe and nearly 125 more than Canada.

The researchers also found that most new drugs are approved in the U.S. before the two other regions. Among drugs approved in both the U.S. and Europe, 64 percent were first approved by the FDA. For drugs approved in both the U.S. and Canada, 86 percent were first approved by the FDA.

"This allows us to focus on the important question of whether there are real barriers to drug innovation in the U.S.," said Kathleen Stratton of the Pew Charitable Trusts, which provided funding for the research. "But it's clear from this study that the speed at which the FDA reviews drug applications is not one of them."

Pew has lobbied for increased FDA funding to assure the safety of food, drugs and other regulated products.

The study authors acknowledge some limitations with the data. For example, they did not account for drugs which are ultimately rejected. FDA and other agencies don't release review times for drugs that are never approved. However, since the FDA approves 80 percent of all the applications it receives, the authors say it's unlikely the missing data would have changed their findings. The study was also limited to novel drugs, which means copycat drugs and reformulations of older products were excluded.

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