Reforming Food and Drug Administration Should Be Priority
August 16, 2011
After health care and entitlement reform, U.S. Food and Drug Administration (FDA) reform should be the number two priority for market-oriented health care reformers. Like it or not, it's the gatekeeper for every new drug and device marketed in the United States, and it's a big reason why it takes over a decade and hundreds of millions of dollars to bring a single new drug to market, says Paul Howard, a senior fellow at the Manhattan Institute.
One FDA reform that should be at the top of Congress's list is the agency's inability to fill its advisory committees with the most qualified experts due to overly stringent conflict-of-interest regulations.
- Today, nearly one in four advisory committee seats (23 percent) are vacant, over double the target rate of 10 percent.
- At the FDA's Center for Biologics Evaluation and Research (CBER), the vacancy rate is a stunning 38 percent.
In the wake of the Vioxx scandal, Congress set a cap on the number of conflict-of-interest waivers the FDA could grant for its committees, under the assumption that researchers who worked with industry were inherently biased and couldn't be trusted to review new products objectively. The only trouble with this argument is that there's no real evidence to support it.
- A 2006 study reviewed four years of voting patterns from 200 meetings of 16 FDA advisory committees.
- While finding that nearly 30 percent of voting members had "conflicts," the study also found that if all the votes by all the conflicted members were removed, not a single committee recommendation would have changed.
- A 2007 study concluded that while it may be possible to find experts with "few or no conflicts of interest," the search would be difficult and many candidates would still require waivers.
Perhaps this explains why so many committee seats are still vacant, and why recusals from FDA advisory committee meetings have led to meeting cancellations and even delays in application approvals.
Transparency is important, but if the FDA ensures that its committees are balanced and represent the most highly qualified experts in their respective fields, there's no reason why industry consultants shouldn't offer the agency advice, says Howard.
Source: Paul Howard, "Don't Forget About the FDA," National Review Online, August 12, 2011.
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