FDA Justifies Rapid Drug Approval Process

With a number of experts unhappy with the quick approval system of the US Food and Drug Administration, the health regulator has defended the system by pointing out that Americans managed to get 24 drugs sooner than other countries. The FDA released the report showing that they gave approval to 35 drugs last year, the second highest number behind 37 in 2009. And while some experts are unhappy over the fact that the health regulator receives user fees, FDA said that the fees have helped speed up the review times.

FDA’s Janet Woodcock said that the quality of applications have also played a part in quicker review with 22 of the 35 drugs being approved in the first review cycle. Woodcock said that the companies are providing all the data needed in the review process which makes it easier for the agency to carry out the review quickly.

FDA Commissioner Margaret Hamburg also pointed out the importance of quality applications and said, “The point we're trying to make is that when high-quality science, good applications come before us, we are able to act swiftly and surely, and we are able to apply considerable regulatory flexibility in our application review process.”



Source-Medindia