No Surprise: FDA Deadlines Greatly Increase Safety Risk

In a first-of-its-kind study, medicines that are approved by the FDA close to or at a mandated deadline have been shown to be much less safe than those not approved near a deadline date.

Examples of unsafe drugs to have been approved near a deadline include Vioxx, Bextra, Rezulin, Baycol.

FDA watchdogs and critics are using this opportunity to spread the word about this one (of several) major problems with the FDA drug approval process. How was this system started? From the AP:

Deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision — either approve or reject — on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority.

Congress tightened the deadline for most drugs to 10 months in 1997.

And about the study:

Amid concern about risky drugs, Harvard professor Daniel Carpenter took a closer look at the impact. First, he found approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any other time.

Drugs approved in that just-before-deadline period had a four- to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster — presumably slam-dunks — or those that miss the deadline, Carpenter concluded.

This latest revelation, along with other major stories that break on what seems like a weekly basis, is yet another reason that the FDA and its drug approval process to be completely revamped.

-- Dylan Blaylock