The U.S. Government Accountability Office (GAO) says that the FDA "lacks a clear and effective process" for monitoring and dealing with postmarket drug safety issues.
This claim was made in a report requested by Congress members in 2004, in the wake of concerns over the FDA's handling of Vioxx, a painkiller that has been shown to cause heart attacks, and also antidepressants, some of which have been connected to suicidal behavior in children.
The report indicates that "there is a lack of criteria [in the FDA] for determining what safety actions to take and when to take them."
If you want to read one of the most fascinating interviews we have ever posted on the site, it would be good to read the one with Dr. David Graham, who works in the FDA and blew the whistle on the Vioxx scandal. These candid remarks from one of the top insiders at the FDA provide amazing insights into just how scandalous the situation is at the FDA.
This report was requested by Sen. Charles Grassley (R-Iowa), one of the few Congressmen lobbying for serious reform of the FDA. And the news, unsurprisingly to anyone who's been paying attention to the FDA's record, isn't good at all ...
Sen. Grassley wasn't surprised about the outcome either, stating that "things that go on in the FDA don't really protect the consumer." Moreover, the FDA, in Sen. Grassley's opinion, doesn't deserve the automatic "seal of approval" it possesses when it comes to drugs.
Although House counterpart Rep. Joe Barton (R-Texas) believes all the FDA needs is "some fine tuning," his parting shot at the agency spoke volumes: Prescription drugs approved by the FDA should keep you out of the hospital, not send you to one.
Arthur Levin, head of the non-profit Center for Medical Consumers, suggested that the FDA should have the authority to fine drug companies who do not complete postmarket testing.
While that's certainly not a bad idea, the financial slap on the wrist the FDA would be able to issue would likely be mere pocket change in comparison to the billions a company can make by beating their competitors to market with, for example, a potentially deadly drug like Vioxx.
The only real solution isn't minor changes to the existing structure, but a complete reform of the FDA. As long as a significant portion of the FDA's budget is being funded by the very companies they are supposedly regulating, real change is virtually impossible.