No Job for an Insider

The $100-billion-a-year pharmaceutical industry, which contributed $4.4 million to George W. Bush and the Republican Party in last year’s election campaigns, is now pressing the administration to select one of three favored-son candidates to head the Food and Drug Administration. It is no surprise that all three--Searle Vice President Michael Friedman, Wyeth-Ayerst Pharmaceuticals executive Bruce Burlington and Merck Research Laboratories President Ed Scolnick--hold high positions in the industry they would oversee, and that is unacceptable.

None of the seven previous FDA commissioners have been recruited directly from the drug industry. Past presidents have recognized that the agency’s 1938 charter calls for independent oversight. That independence has already been seriously eroded, and an FDA chief direct from the industry could make food and drug safety even shakier.

Among other things, the FDA is supposed to ensure that drugs allowed in the marketplace are safe and effective, with a therapeutic benefit that outweighs any risks. But as Times staff writer David Willman documented in a two-year investigation completed last December, drug industry pressure has led FDA regulators to rush poorly tested, potentially dangerous drugs to market even when there is no evidence of their superiority to older, safer medications.

The next FDA head will be in charge of revising landmark legislation to speed drug approvals--legislation that is up for reauthorization in 2002--and of implementing the Dietary Supplement Health and Education Act, a sketchy set of guidelines aimed at encouraging the safe use of dietary supplements.

The FDA did successfully unravel bureaucratic knots that delayed the marketing of some lifesaving drugs, but the surveillance system that was supposed to monitor the long-term health effects of fast-tracked drugs after they were marketed was never fully implemented. The agency does not even require doctors and hospitals to notify it when a drug causes a serious, life-threatening “adverse event.”

At a House Government Reform Committee hearing Tuesday, legislators from both parties agreed that dietary supplements also need more oversight. Underscoring the need are recent reports that supplements like ephedra and St. John’s wort can have hazardous interactions with prescription drugs and the slim but real chance that dietary supplements containing glandular material (such as chondroitin, an arthritis remedy made from cattle trachea supplied partly from Western Europe) could transmit mad cow disease.

The agency clearly needs an independent leader to close gaping regulatory loopholes. President Bush should choose Dr. Raymond Woosley, an associate dean at Georgetown University Medical Center who has won wide respect from health experts for his balanced view that any rapid development of drugs should be tied to stronger safety review.

Woosley has a powerful champion in influential Republican Sen. Bill Frist of Tennessee, a heart surgeon. But choosing him would require some mettle from Bush, for Woosley’s frank statement that the United States needs a “better system for tracking safety problems of FDA-approved drugs” makes the industry nervous. The pharmaceutical companies’ FDA choices represent a stark quid pro quo that Bush, for his own credibility with the American people, should spurn.