What Storm-Tossed FDA Needs

President Bush's nominee to head the Food and Drug Administration, Dr. Lester Mr. Crawford, faces daunting challenges. As acting commissioner for most of the past four years, Dr. Crawford has confronted a kind of perfect storm.

First there were claims the labeling of certain antidepressants failed to warn doctors the drugs caused some adolescents to be prone to suicide. Then the agency was blind-sided by contamination that made half the nation's flu vaccine supply unavailable. Thereafter came revelations about previously unknown side effects of several widely prescribed anti-inflammatory analgesic drugs, and harsh criticism from within FDA about drug safety in general.

There have been less visible problems as well. On Dr. Crawford's watch, senior agency officials have colluded with the U.N.'s unscientific over-regulation of biotech foods, disrupted human gene therapy with overly risk-averse policies, unfairly denied American women access to silicone breast implants, and too quickly pulled the plug on the testing of promising new drugs.

Most important, Dr. Crawford has failed to confront the FDA's problems with excessive risk-aversion and defensive decisionmaking—the first critical step in achieving needed changes. In short, he's the wrong person at the wrong time to guide FDA through political and policy minefields.

<?xml:namespace prefix = st1 ns = “urn:schemas-microsoft-com:office:smarttags” />U.S. drug research and development are in trouble: Costs have skyrocketed, with direct and indirect expenses now exceeding $800 million to bring an average drug to market; fewer than 1 in 3 market-approved drugs recoup development costs.

Even more ominous, applications to FDA by industry for permission to market drugs have steadily decreased since 1995. But drug and biotech companies spend more than $30 billion a year on research, so how can that be? Regulators are continually raising the bar for approval, which without real reform will only worsen.

Rather than continue blaming “lack of good communication with industry,” Dr. Crawford should address the current system's fundamental and systematic flaws.

For years, students of FDA regulation have called for redressing the asymmetry of outcomes from the two types of mistakes regulators can make. A regulator can permit something bad to happen (approve a harmful product) or prevent something good from becoming available (not approve a beneficial product). Both outcomes are bad for the public, but the consequences for the regulator are very different.

The first kind of error is very visible, triggering attacks against regulators from the media and patient groups and congressional investigations. The second error — keeping a potentially important product out of consumers' hands—is usually a nonevent, eliciting little attention, let alone outrage.

Former FDA Commissioner Alexander Schmidt aptly summarized the conundrum: “In all our FDA history, we are unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer.”

As a result, regulators make decisions defensively—to avoid approving harmful products at all cost—so they tend to delay or reject all sorts of new products, from fat substitutes to vaccines and painkillers. That's bad for public health and for consumers' freedom to choose.     

We must have FDA reform of several kinds. We need to insulate policymaking and decisions on individual products from politics as far as possible, make regulators' decisions more data-driven, and improve pharmaco-vigilance—the monitoring of the safety of already marketed drugs. Finally, and most important, we need to redress the pervasive FDA culture of excessive risk-aversion and defensive decisionmaking.     

Sadly, President Bush's nominee is no reformer. A congenial good ol' boy, Dr. Crawford is the ultimate go-along-to-get-along bureaucrat: No fire in the belly there.     

As the head of a powerful industry group predicted recently: “My expectation is that he will at best be a caretaker and at worst asleep at the wheel. We both have known Les for a long time, and I can't say I remember that there was ever a spark of energy there.” He cited specifically Dr. Crawford's “lack of desire to take on the forces on the Hill and in the consumer activist community.”     

FDA is at a critical juncture. It desperately needs a leader who can simultaneously make basic reforms, boost morale in the ranks, and resist media and congressional pressure. It needs a Don Rumsfeld; it is getting a Don Knotts. That means more tough times for the pharmaceutical industry—and for patients who need new and innovative products.