The Burrill Report

A new report comparing health regulatory agencies in the United States, the European Union, and Canada reveals that the U.S. Food and Drug Administration has approved more new, innovative medicines faster than both the European Medicines Agency and Health Canada in the last decade.

The analysis, conducted by researchers at Yale and the Mayo Clinic and published in The New England Journal of Medicine, found that between 2001 and 2010, the FDA’s average review time for a new drug was approximately 15 percent faster than the review times of the EMA and Health Canada.

The FDA has long been criticized by industry groups for being too slow to approve innovative drugs, and has often been accused of being slower than its counterparts in Europe and Canada. The topic has become an even hotter issue this year as the Prescription Drug User Fee Act (PDUFA) undergoes a reauthorization that occurs every five years.

Results from the study, however, counter most of these assertions. The study analyzed 510 applications for novel therapeutics agents approved from 2001 through 2010—225 by the FDA, 186 by the EMA, and 99 by Health Canada.

The median length of time for completion of the first review was 303 days for applications approved by the FDA, 366 days for those approved by the EMA, and 354 days for those approved by Health Canada. The median total review time was also shorter at the FDA (322 days) than at the EMA (366 days) or Health Canada (393 days).
“These findings contradict recent criticisms of the speed of review by the FDA and question whether review speed is justified as an emphasis for PDUFA V, particularly since the FDA continues to outpace its European and Canadian peers,” said the authors.

The authors, however, point out that in running their analysis they did have to omit the drug applications that were rejected because the FDA and most regulatory agencies do not release review times for such drugs. The authors believe, though, that since the FDA approves 80 percent of all applications it receives, it is unlikely that the omitted data would have changed their findings.

Though the results of the analysis and the authors’ specific reference to PDUFA V suggest that the study was done as a means of addressing issues raised in the debate over the new PDUFA legislation, it is unlikely that it will have any significant impact as the FDA and drug industry reached a tentative agreement that Congress is now drafting into law.

Nonetheless, the data may shift some of the discussion on the barriers to drug innovation in the United States from approval times to a focus on other pressing matters.


May 18, 2012
http://www.burrillreport.com/article-approvals_of_innovative_drugs_by_fda_surpass_eu_canada.html