WASHINGTON — 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 foreign counterparts, 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 with 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? 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.
"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.
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."