Lackadaisical FDA Needs a Dose of Vitality From a New Chief

Henry I. Miller, a fellow at the Hoover Institution, is the author of "To America's Health: A Proposal to Reform the FDA" (2000, Hoover Institution Press). From 1979 to 1994, he was an official at the FDA.

FDA Commissioner Mark McClellan is leaving his position after only 16 months in office, far less time than it took for the search committee to find him. Although few would question that McClellan is engaging and smart, he leaves with mediocre accomplishments and with the agency little better off than he found it.

McClellan did little to reform the culture of risk-aversion and the fear of innovation that pervades the FDA. The subtext of regulatory agencies -- not just the FDA -- is that career bureaucrats generally care more about staying out of trouble than about public health. That biases them against timely approvals of innovative products. Yet McClellan removed not a single senior career bureaucrat.

Despite increasingly more powerful and precise technologies for drug discovery, purification and production, development costs have soared. One reason is that the highly risk-averse FDA keeps raising the bar for approval, especially for innovative, high-tech products. Human gene therapy and other treatments tailored to individual patients have been hit especially hard. Americans are literally dying for reform.

On McClellan’s watch, the FDA continued to throw rigid, one-size-fits-all solutions at non-problems. An example is the agency’s decision to deny any drug company the ability to obtain multiple trademarks for the same drug -- for example, Sarafem/Prozac and Propecia/Proscar -- even if they are different formulations for different ailments.


McClellan also failed to modernize the FDA’s bureaucratic approach to regulating old drugs that have been on the market for decades without significant concerns about safety or efficacy but still lack FDA approval.

The FDA has said that if the manufacturer of one of these drugs expends the effort and expense to obtain an approval, all of its competitors will be forced off the market until they also obtain approvals. This recently occurred with extended-release guaifenesin, a well-known cough suppressant. The FDA justified forcing competitors off the market as necessary to “protect the integrity of the drug approval process,” but the outcome has been exactly the opposite: With no incremental protection of public health, the approved product now sells for 700% of the price of comparable products prior to the FDA’s action.

There were other failures of policy and decision-making during McClellan’s tenure. One is the FDA’s record on the regulation of biotech foods. At the same time that U.S. Trade Representative Robert Zoellick and other senior officials in the Bush administration were working for more science-based treatment of biotech foods (that is, those produced from gene-spliced organisms) internationally, they were outflanked by European and American bureaucrats at the deliberations of the food standards agencies of the United Nations. The U.S. delegation to these negotiations was led by a senior FDA food regulator, Robert Lake, whom McClellan repeatedly refused to rein in.

Another abject failure was the FDA’s unexpected decision -- contrary to the advice of an advisory committee -- to leave in place severe restrictions on silicone breast implants imposed more than a decade ago because of safety concerns. Those concerns were unfounded, virtually destroyed an industry and needlessly terrified tens of thousands of American women.

Still another was the agency’s unwillingness to permit the Plan B morning-after contraceptive to be sold over the counter, a decision that reeks of politics.

These are not the actions of an FDA head who believes in science-driven public policy, data as the basis for regulatory decisions, the right of patients and physicians to assume a modicum of responsibility for the risk of medical interventions, and banning politics from regulation. But that is what we need in McClellan’s successor.