FDA And Drug Approvals

FDA Approving Risky Drugs Too Quickly

The Food and Drug Administration (FDA) has been approving new and often risky drugs at an increasing quick rate, a practice some experts believe is hurting more than helping patients.

Experts Thomas J. Moore and Curt D. Furberg tell the Journal of the American Medical Association that problems have already been discovered with the recently released cancer drug Caprela, the multiple sclerosis drug Gilenya and the drug Pradaxa which is used to prevent stroke.

According to the experts in their Journal of the American Medical Association response:

“These examples raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered.”

The authors don’t mince words when it comes to explaining Caprelsa which they claim is

“Sufficiently toxic that overall survival [was] not different from that achieved with placebo.”

In the meantime the drug Gilenya has had negative effects on heart rate and the drug has already been met with “seven major safety issues.”

The final drug Pradaxa, an anticoagulant, has been associated with dangerous bleeding in patients, something the researchers say could have been avoiding with better FDA testing.

In the meantime one FDA official tells the Wall Street Journal that the public wants expedited drug releases:

“I’d like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks.”

That same official adds:

“The cancer community in particular says we haven’t used accelerated approvals enough.”

In 2011 the FDA approved 35 drugs and 16 of them were approved under an abbreviated review.