Wednesday, January 30, 2008

A Mission at Risk

It’s déjà vu all over again.

“Either we’re going to make sure this agency has the resources necessary to do its job, or we’re going to watch it continue to deteriorate.”

That’s Rep. Henry Waxman, speaking yesterday at a hearing of the Oversight & Investigations subcommittee of the House Energy & Commerce Committee. The topic: an FDA Science Board report released late last year that found FDA to be so deficient in its scientific and technological capacities that it is unable to meet its regulatory responsibilities.

Wonder why? It comes down to one simple reason, and it shouldn’t be a surprise to anyone: the regulatory demands on FDA have increased exponentially as funding for the agency has deteriorated.

But wait—didn’t the Prescription Drug User Fee program, reauthorized as part of the drug safety overhaul, fix this problem?

Alas, no. Over the years, FDA’s new drug review activities have received relatively generous funding thanks to PDUFA. It’s everything else—information technology infrastructure, scientific research to support regulatory standards, the crisis du jour that drains resources from everything FDA does—that is the problem.

The modest increase in FDA’s budget for non user fee programs is nowhere near enough to solve that problem, much less support the new authorities the agency received in drug safety. But, hey, we could have told you that—check out our earlier story on FDA’s funding crisis in The RPM Report.

In the words of former FDA chief counsel Peter Barton Hutt, who helped put the Science Board report together, that chronic underfunding has left FDA “barely hanging on by its fingertips.” What’s needed, Hutt recommended, is a doubling of FDA’s budget over the next two years, a 50% increase in employees, and a 5.8% cost of living adjustment every year thereafter—numbers that had chairman Bart Stupak’s head spinning.

Maybe that is why Stupak seemed more interested in bashing von Eschenbach over specifics in the Science Board report. One highlight was a long exchange between the two over what von Eschenbach had requested for funding in the President’s fiscal 2009 budget. Stupak wanted specifics he could compare to President Bush’s numbers; von Eschenbach demurred until the budget is released next week.

You might have thought that after the passage of the drug safety law, Congress would have left FDA alone for a while to implement it. But it doesn’t look like that’s in the cards this year: Stupak promised Commissioner Andrew von Eschenbach at least five more appearances in front of his Oversight & Investigations Subcommittee alone this year. And that’s on the heels of a packed 2007 Hill schedule for von Eschenbach and career FDAers.

So what does this mean for drug companies? Well, it’s not good news: when FDA officials are hauled up to Capitol Hill and bashed over the head for doing a poor job, that doesn’t reflect kindly on the industries it regulates. And as Gail Cassell, Lilly’s VP-scientific affairs testified, when advances in science outstrip FDA’s ability to regulate, that means new therapies don’t get approved in a timely manner.

Perhaps the saddest thing about the FDA Science Board report is that none of the findings are new. The Institute of Medicine and, most recently, the Government Accountability Office, have issued similar reports on the chronic underfunding of the agency. You can find them here and here.

Waxman closed his remarks with this comment: “I hope the Science Board report will be the last report we have to read about the desperation at the Food & Drug Administration.” You can bet Waxman isn’t alone in feeling that way.

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