The FDA Goes on a Self-Improvement Kick
2 CommentsBy Ed Silverman // January 30th, 2007 // 3:30 pm
The agency just announced a new series of steps to restore its lost luster.
These include: forming a new advisory committee on risk communications; reorganizing staff to improve internal communications; a new pilot program to assess postmarketing studies; a new deal with the Veterans Health Administration to share data on drugs; installing a new electronic drug-safety tracking system, and upgrading the adverse-events reporting system.
There will also be “report cards” that would chroniclel unexpected side effects that occur within 18 months after a drug has been approved. The details, which were posted only a short while ago on the FDA web site, came with a rather vague statement by Andrew C. von Eschenbach, the FDA commish, who is reacting to an Institute of Medicine report that skewered the agency.
There are 38 pages to digest, but criticism came quickly from Consumers Union, which issued its own press release describing the changes as “minor improvements” that fall “dramatically short of the changes needed to overhaul the nation’s drug safety system.”
The big beef: The proposal wouldn’t adequately address the major safety problems that can arise once a drug is on the market, according to Bill Vaughan, the group’s senior policy analyst.
This requires deeper digging, but it’s not surprising to hear complaints that the FDA isn’t going far enough. Expect more criticism and posturing now that a Democratic Congress is eyeing the agency. Several senators are expected to introduce bills to reform FDA in the coming days. Clearly, the agency may makes some changes, but this is merely an interim step.
[tags]Consumers Union, FDA, Institute of Medicine[/tags]
Melody
Merrill Goozner had a pair of cogent points regarding the FDA “makeover” posted on his GoozNews dot com website:
One would be a requirement that all new drugs coming before the agency get tested against existing therapies as part of their initial regulatory approval process. This would provide physicians with important information for determining if the new drug was any better, or worse, than what’s already out there. This might be a blow to the marketing departments of major pharmaceutical firms, but a solid advance for evidence-based medicine.
The other reform would be further restrictions on physicians’ ability to prescribe drugs for other than their FDA-approved use, so-called off-label prescribing. Many of the worse abuses of the drug marketers have come from their illegal promotion of off-label use of drugs.
ed silverman
Very good points, although I think these would be considered revolutionary, not part of a mere makeover. In any event, the odds of such steps taking place seem slim, though, don’t they?