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A Poor Helmsman Navigates FDA’s Perfect Storm

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A Poor Helmsman Navigates FDA’s Perfect Storm

Miller Op-ed in Tech Central Station

The President's nominee to head the FDA, Lester Crawford, faces daunting challenges. As acting commissioner for most of the past four years, Crawford has confronted a kind of perfect storm. First there were claims that the labeling of certain antidepressants failed to warn doctors that the drugs caused some adolescents to commit 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 the agency about the safety of drugs generally. There have been less visible problems as well. On Crawford's watch, senior agency officials have colluded on the UN'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, Crawford has failed to confront the FDA's problems with excessive risk-aversion and defensive decision-making—which would be the first critical step in achieving needed changes. In short, he's the wrong person at the wrong time to guide the agency through political and policy minefields. Research and development of drugs in the United States are in real trouble: The costs have skyrocketed, with direct and indirect expenses now exceeding $800 million to bring an average drug to market; and fewer than one in three drugs that are approved for marketing ever recoup their development costs. Even more ominous, the number of applications to FDA by industry for permission to market drugs has been steadily decreasing since 1995. But drug and biotech companies spend more than $30 billion a year on research, so how can that be? The reason is that regulators are continually raising the bar for approval, which in the absence of real reforms will only get worse. Rather than continuing to blame "lack of good communication with industry," Crawford should address fundamental and systematic flaws in the current system. For years, students of FDA regulation have called for redressing the asymmetry of outcomes from the two types of mistakes that regulators can make. A regulator can commit an error by permitting something bad to happen (approving a harmful product), or by preventing something good from becoming available (not approving 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 highly visible, causing the regulators to be attacked by the media and patient groups, and to be investigated by congress. But the second kind of error -- keeping a potentially important product out of consumers' hands—is usually a non-event, eliciting little attention, let alone outrage.Former FDA Commissioner Alexander Schmidt aptly summarized the regulator's 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." Former FDA General Counsel Peter Barton Hutt echoed Schmidt, asserting that "FDA employees have been praised only for refusing to approve a new drug, not for making a courageous judgment to approve a new drug that has in fact helped patients and advanced the public health."As a result, regulators make decisions defensively—in other words, to avoid approvals of harmful products at any cost—so they tend to delay or reject new products of all sorts, 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 policy-making and decisions on individual products from politics insofar as that is possible, make regulators' decisions more data-driven, and improve pharmacovigilance—the monitoring of the safety of already-marketed drugs. Finally, and most important, we need to redress the culture of excessive risk-aversion and defensive decision-making that pervades FDA.Sadly, President Bush's nominee is no reformer. A congenial good ol' boy, 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 that I remember that there was ever a spark of energy there." He cited specifically 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 carry out basic reforms, boost morale in the ranks, and resist pressure from Congress and the media. At a time when it needs a Don Rumsfeld, it's getting a Don Knotts. That means more tough times for the pharmaceutical industry -- and for patients who need new and innovative products. <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />