Comparative Regulatory Review of Drugs

Drug manufacturers frequently complain that Food and Drug Administration procedures are adding to the expense and time involved in getting a product to market.  If the drug is truly innovative and beneficial, patients can be harmed by the delay.  Researchers examined how the FDA compared to two other important agencies for drug approvals–Health Canada and the European Medicines Agency.     (NEJM Article)   The study focused on novel therapeutics, so the results may not apply to follow-ons, generics, etc.  It also only considers the time from filing to approval or denial, so the potential effect of an agency on the total time involved in drug development was not considered, and regulatory agencies can have a substantial effect on the earlier phases of drug development.  But the reviewers found, contrary to a popular impression, that the FDA is actually faster than the other agencies in reviewing drugs, on average.

Of 510 applications which led to approval for 289 unique compounds from 2001 to 2010, the median length of time for completion of the first review was 303 days for the FDA, 352 days for Health Canada and 366 for the European Medicines Agency.  The range of times did tend to be longer for the FDA, so perhaps the outliers in length help create the impression of delays.  The median total review time was also shorter for the FDA.  Of these 289 compounds, 190 were approved in both the US and Europe, and among those, 121 were first approved in the US.  Similarly, 154 were approved in both the US and Canada, with 132% of those first approved in America.  So generally patients get access to a new drug faster in the United States than in Canada or Europe.  Agencies have responsibility for safety, so speed may not always be good, but certainly drug manufacturers appear to have more reason to complain about some other major agencies than the FDA.