In the wake of the Vioxx debacle, physicians and consumers alike have lost confidence in the FDA's ability to ensure patient safety. And no one can blame them.
Since Vioxx, nothing has really changed. The FDA continues to review drugs before they get to the market, but does virtually nothing to compare drugs and systematically assess them for safety once they get there.
Millions of Americans now take a new class of antidepressant drug called SSRIs, millions of Americans rely on drugs such as Celebrex for pain relief, and millions of Americans take statin drugs such as Crestor and Lipitor for high cholesterol.
Will Celebrex be the next Vioxx? Will Paxil? Lipitor? We don't know. There have been no comparative long-term clinical trials to test the safety of these medications now that they are on the market. This needs to change.
In the next two years, policymakers will revisit how the FDA spends user fees it collects from pharmaceutical companies. The user-fee program charges drug companies a fee for every drug they submit to the FDA, and the funds are used to expand the FDA's review staff.
It is clear that the user-fee program has accelerated the pace of FDA drug approval. To many physicians, patient advocates, consumer advocates, academic researchers, and members of Congress, however, the user-fee program has also compromised the FDA's regulation of drug safety; they say it has changed the culture of the agency, diverted resource, and emphasis on pre-market review, and imposed stringent deadlines on FDA reviewers. The user-fee program, these critics believe, has worsened the FDA's scrutiny of drug safety, especially long-term safety.
In 2007, policymakers have a chance to re-vamp the user-fee system. They should use that opportunity to increase user fees and use those funds for rigorous post-marketing study of drugsnot simply quick approvals.
The current user-fee arrangement exacts a per-application fee upon pharmaceutical sponsors who submit new product applications to the FDA. In theory, these funds are then used to purchase more reviewers. But this is not enough to ensure patient safety.
The FDA should increase these fees and use the new monies on post-marketing safety studies, preferably long-term randomized and controlled clinical trials that directly compare one drug to another.