The Food and Drug Administration has been without a commissioner since David Kessler's departure in February 1997. Even in the best of times, it is a difficult job to fill. The press of issues ranging from drug approvals and recalls to food safety makes it grueling; the pay is far less than top candidates can command in the private sector; and former commissioners have not typically advanced to better jobs.
Jane Henney, vice president of the University of New Mexico's Health Sciences Center and a former FDA deputy commissioner, was nominated for the top job Wednesday. Dr. Henney is a quintessential Clinton choice: a true believer in arrogant, intrusive, damn-the-expenses government regulation. While she was deputy commissioner (1992-94), the regulatory burden on drug companies grew. The drug-development system in the U.S. has become the slowest and most expensive in the world, with development times more than doubling to almost 15 years since 1964, and the average cost of developing a single drug rising to more than $500 million from $359 million just between 1990 and 1993.
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The agency's scope is so sweeping (encompassing, among other things, cardiac pacemakers, X-ray machines, condoms, home pregnancy-testing kits, drugs, vaccines, artificial sweeteners and fat substitutes) that a single person cannot be expected to master the body of science, medicine, pharmacology and engineering involved. Beyond those areas there is also "regulatory science" and law. The FDA's professional staff frames the issues and options, while the agency head sets the overall tenor, manages the far-flung empire and makes the final decisions on difficult policy questions.
The FDA commissioner's management and decision-making must meld law, science, medicine and regulatory precedents in a way that maximizes the public interest. The agency head needs to earn the respect of those who have a stake in the FDA's policies and decisions--patient groups, individual consumers, drug companies and Congress--through candor and consistency. But as deputy commissioner, Dr. Henney was considered unapproachable and intransigent by both industry and her colleagues.
What's more, her decisions often appeared to be motivated by politics. As co-chairman of the Public Health Service Task Force on Breast Implants in 1992, Dr. Henney collaborated prominently in the disastrous government decisions that needlessly left millions of women fearful and confused and that destroyed the silicone-implant industry. As an FDA official, Dr. Henney was willing to delay the approval of certain politically incorrect products (bovine somatotropin, a protein that enhances milk production, opposed by Vice President Al Gore and his staff) and to expedite others (a female condom with dubious efficacy, lauded as a "feminist" product by Health and Human Services Secretary Donna Shalala).
The next FDA commissioner must be committed to regulatory reform. The FDA needs to streamline its existing regulatory procedures and requirements in ways that will significantly cut the time and costs of drug development. The agency's managers must be made more accountable for their decisions, especially when they delay important new drugs, vaccines and medical devices. But during her tenure at the FDA, Dr. Henney, who supervised all of the agency's operating divisions (which oversee clinical testing, review and approve products, ensure compliance with regulations, monitor side effects and issue product recalls), showed no sign of perceiving the need for reform.
Indeed, a congressional effort at substantial reform was sabotaged last year by the very senator who is championing Dr. Henney's nomination, Edward M. Kennedy (D., Mass.). Dr. Henney's husband, Robert Graham, is a liberal health-care lobbyist and a former Kennedy aide.
The FDA commissioner should be insulated from politics and willing to take the heat for unpopular decisions. Dr. Henney was invariably willing to go along to get along. She capitulated to the White House not only on matters of policy (which may be appropriate), but also on decisions that concerned individual products and personnel. When the Clinton administration took over in 1993, Dr. Henney shuffled civil servants around on instructions from Mr. Gore's staff, a contravention of civil service regulations.
The FDA regulates products accounting for approximately 25 cents of every consumer dollar--worth more than $1 trillion annually. Milton Friedman has observed that some government agencies interfere in the free market because they mistrust freedom itself. Dr. Henney has helped make the FDA into such an agency. The Senate should reject her nomination lest she further politicize the powerful agency.
Dr. Miller is a senior research fellow at Stanford University's Hoover Institution and the author of "Policy Controversy in Biotechnology: An Insider's View" (R.G. Landes Co., 1997). From 1979 to 1994 he held various positions at the FDA.