Safety first

Pharmaceuticals

Feb 17th 2005
From The Economist print edition

Pain relief for America's drug regulator

THE past few months have not been easy for America's Food and Drug Administration (FDA).The worldwide withdrawal of Vioxx, a blockbuster anti-inflammatory drug, by Merck, its manufacturer, has left the FDA open to attack for doing too little, too late given mounting evidence that the product raises the risk of heart attacks. David Graham, one of its own officials, publicly accused the agency of being more interested in getting new drugs to market than scrutinising their safety after the fact. “The FDA has let the American people down and, sadly, betrayed a public trust,” he told Congress in November. The FDA—which this week has been holding a marathon advisory committee meeting on the risks and benefits of Vioxx and other COX-2 inhibitors—faces further scrutiny as various congressional committees take up the issue of drug safety.

Slowly, the Bush administration is responding to the criticism. On February 15th, Michael Leavitt, the new secretary of health and human services, announced the establishment of an “independent” Drug Safety Oversight Board within the FDA. This will routinely review emerging evidence about the safety of drugs that are already on the market, and make recommendations based on this information. It will also introduce new ways of communicating information about drug safety to the public. The board will bring together officials from the FDA's existing divisions in charge of new drug approvals and drug safety, plus some outside experts.

This is less than some politicians and public-health activists want: an entirely separate, and thus (they argue) truly independent, office of drug safety, well-funded and beyond the reach of the FDA's drug-approval branch (which they regard as too eager, and potentially tempted to downplay any evidence that its own approval decisions were mistaken). Others disagree. Pushing the FDA to weigh safety more heavily than benefit may already be a move too far, says Henry Miller, a former FDA official now at the Hoover Institution, a think-tank. Any slowdown in the approval of more innovative, but riskier, new medicines could, on balance, do Americans more harm than good, he claims.

The FDA this week also got (probably) a new head, albeit a familiar one: Lester Crawford, a former deputy commissioner and acting head of the agency since last year, has been nominated as the next permanent commissioner. He is likely to get the green light in Senate confirmation hearings. And he should be good news for the drug industry, says Rami Armon of Lehman Brothers, an investment bank. The industry wants a safe pair of hands to implement gradual reform of the FDA, not radical remodelling. But some observers fear that Mr Crawford, a veterinary expert, lacks the right experience or personality to handle negotiations with the big drug firms. “The FDA needs a firebrand, not a smouldering hulk,” says Mr Miller.

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