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Many Talents Needed for FDA Post
Many Talents Needed for FDA Post
Miller Op-Ed from Scripps Howard
April 06, 2004
The departure of FDA Commissioner Mark McClellan leaves a high-level opening in the Bush administration for the right candidate. It's a hard job, but a potentially rewarding one, offering the opportunity to influence policies and decisions that affect the profitability and viability of products worth more than $1 trillion annually. <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
Those with an independent streak or industrial experience need not apply. The Bush administration will require that the new commissioner toe the party line on reproductive issues, therapeutic cloning and re-importation of drugs to the <?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />United States from abroad, while Sen. Ted Kennedy, D-Mass., the ranking member of the Senate Health, Education, Labor and Pensions Committee, will reject any candidate with past ties of any kind to regulated industry.
Ideally, the nominee should be equal parts consummate manager, technocrat and Lord High Executioner. Realistically, he must have several attributes:
--Superior management skills and experience. The agency's scope is so sweeping— encompassing 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 (to say nothing of the law and "regulatory science") involved.
The FDA's own professional staff can frame the issues and options; the function of the agency head is chiefly to manage the far-flung empire, craft appropriate incentives for moving products through the pipeline more efficiently and make the final decision on difficult policy questions.
--Unassailable integrity and honesty. The commissioner's decision-making must meld law, science, medicine and regulatory precedents in a way that maximizes the public interest. The incumbent needs to earn the respect of those who have a stake in FDA policies and decisions— that is, patients' groups, individual consumers and drug companies _ with candor, consistency and rectitude.
--Commitment to regulatory reform. The FDA needs to streamline its existing regulatory procedures, eliminate unnecessary requirements and work with Congress on new approaches that offer non-governmental alternatives to some of the agency's functions. The latter could include enhanced reliance on extramural expert advisory committees, contracting out product reviews and the creation of a mechanism analogous to Underwriters Laboratories' (extra-governmental) certification of tens of thousands of classes of consumer products.
--In addition, the FDA's senior and mid-level managers must be made more accountable for their decisions—especially those that delay the availability of new drugs, vaccines and medical devices to patients in need of them. One way to achieve that would be to create an independent, strong ombudsman mechanism that could impose negative sanctions on civil servants who transgress. This is where the Lord High Executioner comes in. The agency head cannot make a tasty public policy omelet without breaking some bureaucratic eggs. Putting it another way, some of the FDA's senior managers are most assuredly past their "use by" dates, and need to be moved to positions where they can do less damage.
--Distanced from politics. The FDA commissioner's job should not be awarded as a political plum, as are Cabinet posts and many ambassadorships. Politics should be banished insofar as that is possible, with the commissioner doing what is in the public interest and then taking the heat from all quarters for unpopular decisions. (Under McClellan, not only broad policies but also some decisions on individual products—such as the decision not to approve the "Plan B" morning-after contraceptive for over-the-counter use—appeared to be dictated by political considerations.) A corollary is that the commissioner should probably not aspire to higher political positions in government: Doing the job right makes plenty of enemies.
Applications may be sent to 1600 Pennsylvania Avenue N.W., Washington, D.C. 20500.
(Henry Miller, a physician, is a fellow at the Hoover Institution and the Competitive Enterprise Institute and the author of "To America's Health: A Proposal to Reform the Food and Drug Administration." He was an FDA official from 1979-1994.)