TCS Daily


Is the FDA Broken?

By John E. Calfee - March 30, 2005 12:00 AM

Is the FDA broken? A lot of people think it is. They argue that the FDA has gone soft on drug safety because it tries too hard to please the pharmaceutical industry. Their evidence is the FDA's reluctance to pull the popular pain killer Vioxx off the market, along with disputes about the safety of antidepressants and other drugs. Their solution is for Congress to create a new drug safety board completely separate from the part of the FDA that approves new drugs. Prominent politicians of both parties and a raft of academic experts agree.

This plan suffers from three fatal flaws. First, it attacks a problem that doesn't exist. Second, the plan wouldn't solve the problem even if it did exist. And third, it would make things worse.

Is the FDA staff biased against drug safety? Sure, the FDA receives millions of dollars in user fees from the industry and it uses the money to make decisions faster. But it keeps the money regardless of how the decisions turn out. The best way to figure out whether there is a bias is take the perspective of an FDA new drug reviewer. If a reviewer is too slow in letting a drug on the market, usually only the manufacturer and a few researchers and patients notice. But if the reviewer moves too fast and approves a drug that even looks unsafe, there will be heck to pay. That's exactly what happened in the last few months: Congressional hearings and a "60 Minutes" program featuring an FDA malcontent, dozens if not hundreds of editorial assaults on the agency, and blistering attacks from normally sedate medical journals.

It's the same way with drugs already on the market. FDA leadership has endured a torrent of abusive criticism for not having clamped down on Vioxx and similar drugs such as Celebrex. Four years ago, the Los Angeles Times won a Pulitzer Prize for its stories about the FDA's reluctance to pull a different drug. We practically never see the flip side: extravagant praise for the FDA staff for having kept a drug available after carefully balancing risks and benefits in the face of worrisome new safety information.

Let's face it. If there's an FDA bias, it is to be too careful about drug safety rather than to be careless. That bias has probably gotten worse in the past six months.

But let's suppose Senator Grassley and other critics are right when they say the FDA has a vested interest in protecting a drug it has approved. How could an FDA shake-up fix that? A drug safety board, no matter how independent it is, would issue a steady stream of decisions about approved drugs simply because safety questions constantly crop up. Almost always, the board would decide the drug is safe enough to keep available for patients. From that point on, the safety board would have just as strong an interest in defending the drug as would the bureaucrats who first approved it.

This brings us to problem three: An independent drug safety board would make things worse precisely because it would be independent. Drug safety cannot be assessed separately from effectiveness. Even the best drugs have side-effects. If the FDA could forget about benefits and just concentrate on safety after approving a new drug, maybe an independent safety board would make sense. But the FDA can't do that. Information about both effectiveness and safety emerge in a continuous and highly unpredictable flow. The miraculous cholesterol-reducing drugs (Lipitor, Zocor, and their competitors) reveal problems when millions of patients take them, but the benefits stack up even faster. Any board that is serious about drug safety would have to immerse itself in how drugs are used and what benefits are being discovered and documented. Instead of an independent board, we need an organization that merges the safety and effectiveness information coming from clinical practice. That is exactly what the FDA is already trying to do on its own. This is one time when Congress should just let the FDA get on with its job.

The author is a fellow at the American Enterprise Institute.

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