After a lengthy wait, the nonpartisan Government Accountability Office (GAO) finally issued its report on postmarket monitoring of drug safety by the FDA, as requested by Sen. Charles Grassley (R-Iowa), one of the few Congressmen lobbying for serious reform of the agency. And, the news, as you probably guessed, isn't good at all...
In the brief accompanying the full report (free PDF link below), the GAO found the FDA "lacks clear and effective processes for making decisions, about, and providing management oversight of, postmarket safety issues." In fact, "there is a lack of criteria for determining what safety actions to take and when to take them."
Sen. Grassley wasn't surprised about the outcome either, considering "things that go 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.
The report also recommends the FDA authority be expanded to compel drug companies to complete postmarket drug testing under the threat of a fine. Unfortunately, the financial slap on the wrist the FDA might issue in the form of a fine to a mega-drugmaker, if they choose not to conduct testing, is mere pocket change in comparison to the billions it can make by beating their competitors to market with, for example, a toxic drug like Vioxx.
USA Today April 24, 2006
Government Accountability Office April 24, 2006 Free Full PDF Report