After Obamacare and entitlement reform, FDA reform should be the #2 priority for market-oriented health-care reformers. Like it or not, it’s the gatekeeper for every new drug and device marketed in the U.S., 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. Getting innovative new products through the FDA’s development and approval process faster and less expensively would improve public health and help lower health-care costs.
For the next year, FDA reform will be up for grabs. Every five years, Congress reauthorizes a critical piece of FDA legislation: the reauthorization of the Prescription Drug User Fee Act (PDUFA), a “must-pass” piece of legislation that offers a real opportunity to rethink how the agency does business. The next reauthorization is due in 2012.
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 FDA’s target rate of 10 percent. At the FDA’s Center for Biologics Evaluation and Research (CBER), the vacancy rate is a stunning 38 percent.
The problem has gotten to the point where the agency’s senior leadership is talking about it in public. At a recent conference, Dr. Janet Woodcock said that “there is no doubt it is difficult finding highly experienced people who do not have conflicts” to serve on the agency’s advisory committees.
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 by Public Citizen in JAMA 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.
The FDA re-analyzed the same data and found if the definition of a “conflict” was expanded to include a committee members’ purported financial interest in a competitor’s product, voting patterns actually tended to go against the panelists’ interests.
The late Jack Calfee, from the American Enterprise Institute, offered a simple but powerful explanation for why elite researchers wouldn’t be beholden to companies they consulted for:
. . . in the researchers’ world the dominant coinage is reputation among peers, from which all else flows. Committee members’ must know that if they vote more consistently with their short term financial interests than with their take on the science, their famously prickly colleagues will catch on. That would mean impaired professional relationships and eventually a distressing erosion in awards, prestige, and even income.
There is no doubt that the most qualified scientific experts often consult with industry. A study the FDA commissioned in 2007 found that members of the standing committees who were granted waivers had higher “overall measures of expertise” than committee members who weren’t granted waivers. It also found that the median value of financial interests who were granted waivers was relatively modest, $14,500.
The 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, and members serving on FDA’s advisory committees should disclose their industry sponsored research or consulting. 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 — which, after all, the agency can ignore.
Otherwise, the agency’s current conflict-of-interest policy will keep the FDA from getting the best scientific advice — and keep patients waiting longer for innovative new therapies.