FDA Reform Is in the Air

The Food and Drug Administation, responding to the scathing Institute of Medicine report issued last September, launched a preemptive strike on drug safety yesterday to forestall legislative changes. You can read the details in news accounts here, here and here, or look at the FDA's own documents here.

It's a start, was the generous consensus. "Small potatoes," said Consumers Union, a view generally in line with my own. When I asked the head of the Center for Drug Evaluation and Research whether the agency would force companies to conduct post-marketing safety trials (most of those requests, issued at the time of approval, are ignored by the companies), Steve Galson replied that it would be up to Congress to give the agency that authority. Yes, but that begs the question, Dr. Galson. Do you want that authority? Will the Bush administration you serve ask for it in the budget request released next week? And, if it is given, will you use it?

The agency was also dodgy in its response to the issue of prohibiting scientists and physicians with conflicts of interest from serving on its advisory committees, which play a powerful role in determining if marginally effective or mildly dangerous drugs (because of side effects) get to market. These are the risk-reward trade-off decisions that the agency is often called upon to make, the ones that are as much about human judgment as they are about science. They often turn to outside advisers for help in that process through a committee structure that has received withering criticism from consumer groups and some physicians as being overly biased toward approving new drugs. Getting rid of conflicted advisers -- even though their votes have been shown to not be all that different from advisers without conflicts of interest -- would open slots for creating more balanced panels.

Randy Lutter, who manages policy for the agency, did say that the agency planned to put more epidemiologists on these committees, which presumably would give them additional insights into how drugs affect large populations once on the market. But he refused to give a definitive answer to how they'll handle the conflict-of-interest issue. We'll have to await a guidance document, which will be released later this year.

Meanwhile, Sens. Chris Dodd (D-CT) and Charles Grassley (R-IA) told the New York Times that they plan to reintroduce their legislation calling for a legislative overhaul of the agency. Which brings me to the final curious comment in that story. Scott Gottlieb, who recently left his political appointment at the FDA to return to the conservative American Enterprise Institute, said that the real battle this year will be over FDA intrusion into the practice of medicine. “I think we need to give the agency the resources it needs to get information about drug risks quickly,” he said. “But we don’t need the government telling doctors and patients what to do.”

I can think of two reforms that would constitute such an intrusion. 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.

If these are the issues Gottlieb referred to, I say, bring it on. These would be very valuable discussions to have in Capitol Hill hearings later this year, say around reauthorization of the Prescription Drug User Fee Act, which provides over half the funds for the FDA's new drug approval activities and expires next October.

Posted by gooznews at January 31, 2007 09:02 AM