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.
The Pharmaceutical Research and Manufacturers of America did not comment directly on the findings. However, the group said in a statement it appreciates "the importance of balancing timely access to new medicines with the need for thorough review of safety and efficacy data."
While the study appears designed to influence drug user fee legislation, it may come too late in the process to have much impact. The FDA and the drug industry reached a tentative agreement last fall, with the agency pledging to work toward faster, more predictable reviews in return for a 6 percent increase in company fees. Congress is now drafting the agreement into law, including provisions added by lawmakers who want to accelerate FDA drug approvals even further.
The latest draft of the user fee bill on Capitol Hill would task the FDA with speeding up the approval of breakthrough drugs by relaxing certain requirements, including allowing drugmakers to conduct smaller, shorter clinical studies. The approach has been embraced by top FDA officials, who have spent the last year highlighting their efforts to accelerate development of novel medical products. Innovation has been a key talking point for the Obama administration since early 2011, when the president outlined a strategy to boost economic growth by encouraging innovation by companies and federal agencies.