Not Enough Science

FDA has more than its share of problems these days. But if you go by the news, you might conclude that they're all political at heart—the result of pressure from the industry, Congress, and a public that's losing its collective mind over drug safety. So much ink and angst have been expended over the agency's independence and internal squabbles that it's almost a relief to be reminded that it has other problems—great big ones that threaten FDA's ability to do its job and that put the public at risk.

I'm thinking, of course, of FDA Science and Mission at Risk, the report issued in November by the FDA Science Board Subcommittee on Science and Technology. It made relatively little splash in the press. That was a surprise, because the report was a scorcher, devoting almost 60 pages to proving that FDA has fallen desperately behind in scientific capability, to the point where it simply cannot do its job. The primary culprit: the usual one—chronic, decades-long lack of funding.

Patrick Clinton

Some specifics:

• The science of food and drugs has changed, the report says, but FDA's scientists haven't kept up. Not only can they no longer lead industry, they're having a hard time just keeping up.

• To do science requires scientists, and FDA has difficulty recruiting and retaining them. The personnel turnover rate for key scientists at FDA is double that of other government agencies.

• The agency has no way to evaluate its scientists, says the subcommittee. It doesn't invest enough in developing them, and it doesn't have extensive relations with outside scientists who could help remedy the expertise shortfall.

• The agency's IT system is inadequate and unreliable. Its IT budget is about half that of the Centers for Disease Control, which has a similar-size staff and significantly smaller responsibilities.

• Perhaps most dauntingly, the report argues that FDA lacks expertise in statistics and risk–benefit assessment (you know, the science the agency uses in deciding whether to approve drugs or not).

I said it was a relief to hear this critique, and it is. The newspaper model of what's wrong with FDA is designed primarily to spotlight the virtue and public spirit of the politicians enunciating the problems. It's pretty hard to get from there to a practical model of reform, though IOM has certainly made a fair effort.

This subcommittee report, on the other hand, can lead to action pretty directly. Are we unhappy with FDA's understanding of safety? Well, maybe we should hire a bunch of top-line safety scientists and let them go to work. Are we unhappy with the way decisions get made on risk? Maybe we should get some expertise on board and formalize the decision-making process. If we're worried about politics and influence, maybe we should make sure there are scientists available to build more robust procedures for approving drugs.

I wish I believed the scientific rebirth of FDA was really on the national agenda. Unlike so many of the issues the political candidates are flogging this season, this is one where change could actually take place—and it would make a huge difference. It would cost money, but not as much as it will cost us to allow the United States to slip out of its position of leadership in food and drug regulation.

The good news is that FDA isn't really broken. It's just broke. That's not so hard to fix. The question is, Who cares enough?

Patrick Clinton

Editor-in-chief

pclinton@advanstar.com