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Memo to FDA Commissioner Mark McClellan: first do no harm.

Judging by its quiet effort to enlist scientists of academic fame to advance its political agenda on everything from global warming to stem cell research, the Bush administration apparently believes such practice is acceptable. Thankfully, Mark McClellan, M.D., Ph.D., the new commissioner of the U.S. Food and Drug Administration, seems refreshingly uncommitted (see “Prescription for the FDA,” page 80 of the Journal, Issue 2). But is he untouchable?

Like any government bureaucracy, the FDA has its problems. The agency can�t seem to figure out how to regulate alternative medicine and nutritional supplements, and it�s oddly confused about its purview over drug marketing. There are other potential problem areas, too, including devising testing protocols for bioterrorism products and biologic generics. Dr. McClellan has taken on these and other matters with a zeal not seen at the FDA in years. But zeal can be mixed blessing.

This is the sum of our fears: it is fashionable among Washington�s conservative think tanks and industry lobbying firms to conflate the rising cost of health care with the FDA�s problems. Critics of the FDA point to the fact that prescription drug prices are rising at an unsustainable rate of 10% per annum. In an attempt to shift the blame from pharmaceutical companies, lobbyists and free marketeers argue that the FDA and its product review systems are the real problem, and Dr. McClellan, who came to the FDA from the President�s Council of Economic Advisors, where he had been working on Medicare reform, seems to want to accommodate industry.

The FDA can, at once, modernize and protect the public�s health. In the first six months of his tenure, Dr. McClellan has tried to do just this, by insisting, for example, that medicines henceforth include a bar code to ensure that key label and dosing information is not misinterpreted. This could save 100,000 lives every year.

But we wonder if the good doctor, whose political fortunes are intertwined with those of the Bush White House and who has served as a fellow at the conservative American Enterprise Institute, will resist those forces that want to reform the FDA out of existence. We hope so.



Chronic diseases and the reinvention of health care.

Bioethics: more rational, less political.

» Mark McClellan brings new leadership to the FDA.

Toward a plan to make safe generic versions of biologics.

By Invitation

Larry Brilliant