News
BMJ analysts have shown that since the FDA introduced the fast track approval procedure in 1992, many drugs (112) have not proven effective.
In particular, of the 253 drugs that received regulatory approval through the accelerated procedure that were included in the sample, the efficacy of 112 was not clinically confirmed.
Although the accelerated approval process allows drugs to enter the market before their efficacy is proven, the manufacturer must conduct a post-registration study to confirm the expected clinical benefit.
If these trials are not successful, the application for approval of the drug may be rejected. Most of the drugs listed in the red segment were ineffective, although in some cases confirmatory tests were not performed.However, even with the negative in mind, experts still agree that the accelerated path of approval of new drugs still has more benefits than risks.