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How to Heal the FDA
Staying one step ahead of new technologies, let alone balancing their risks and rewards, is no small challenge – especially for a large bureaucracy without a proper leader. Lester Crawford, the acting boss, is by all accounts a decent man, but he’s a caretaker. The FDA needs a leader strong enough to obtain the money and autonomy the FDA needs to do its job – a leader wise enough to reconcile the competing needs of the public and the hugely powerful industries that it regulates. The agency needs an inspiring manager with a public face that the American people recognize and trust, and a stalwart that industry respects – perhaps even fears just a bit. Now that Michael Leavitt, the former chief of the Environmental Protection Agency and an ideological soul mate of President Bush, has been hired to run the Department of Health and Human Services – whose jurisdiction includes the FDA – the White House and Congress must turn their attention to filling the void at the top of the FDA.

As Kennedy and others have noted over the past few years, the White House and the Republicans on Capitol Hill have wanted to put a politically reliable figure in charge of the FDA. The FDA would benefit more if it got somebody like Walter G. Campbell, who served two tours as chief between 1921 and 1944, for a total of 20 years. Interestingly, Campbell was neither an MD nor a PhD, but a Kentucky lawyer who was handpicked, Hilts tells us, by Harvey Wiley, the agency’s first head and a man who, like Theodore Roosevelt, began his professional life as a Republican only to leave to join the Progressive movement. In addition to giving the FDA stability – he remains the longest-serving chief – Campbell gave the agency armor-coated legitimacy.

The next FDA boss must sometimes turn a deaf ear to politics and find a way to prove to doubters that the agency will never put the business interests of the drug industry ahead of the safety of the public. The next FDA commissioner must continue the “de-layering” of the chain of command to improve communication between the labs and field staff, working to avoid future incidents where serious safety concerns get shouted down or overlooked. Most importantly, the new commissioner must do what is necessary to force Congress to give the agency the budget and authority that it needs to do its job properly. Congress should not be allowed to dither any further. The FDA was created in the first place precisely because Congress was viewed as an unreliable guardian of public health.

As the agency’s first boss, Wiley, a food chemist, persuaded Roosevelt that Congress could not and should not be trusted to police the safety of food and drug products. Hilts writes that “what bothered Wiley, who loved both research and commerce, and participated in both throughout his life, was that in research there was a strong sanction against deceit, while in commerce deceit seemed to be an accepted tactic to achieve profits. There was some disjoint there.” Wiley and Hilts demonize industry a bit much, but not entirely without cause.

The drug industry has competing interests; the FDA should not be put into a similar bind. As Hilts puts it, “The logic of ‘profit alone’ that dominated the companies in the nineteenth century still dominates them today. This is one reason the FDA’s job is difficult, and necessary.” The Vioxx fiasco could have been avoided. But it is also important to remember that Americans should not expect the FDA to squeeze out every last ounce of risk from food and drugs. Neither should politicians, drug industry critics, and reporters. New medical products bring new risks – that is their price. But with a few notorious exceptions, the FDA does everything in its power, given its overextended resources, to keep medicines that are unnecessarily risky off the market – and help the public understand the risks of those that are allowed past its gates.

Because of last year’s scandals, those who denounce the FDA have fresh cause. But there will always be debates about whether the agency’s quiet successes outweigh its misadventures. Yet 100 years after its establishment, this much is not in dispute: the FDA succeeds in its mission more often than not, despite needlessly long odds. It could do even better if it had the money, management, staff, and technology to do its job properly.

Stephan Herrera writes about the business, science, and politics of medicine and health care. He is a contributing editor at Nature Biotechnology and a frequent contributor to the Economist and Technology Review.

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