The following is excerpted from a forthcoming article by CMPI Board of Advisory member Henry Miller …
Ideally, the nominee for FDA commissioner 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. Also, the commissioner needs to be competent to perform reality checks for the senior staff. An excellent example is the agency’s oversight of food biotechnology: FDA regulators have in place a scientific and workable policy, but at UN-based negotiations on food standards, they have proposed and supported unscientific approaches to biotech foods that conflict with their own domestic policy.
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’s policies and decisions — that is, patient groups, individual consumers and drug companies — with candor, consistency and rectitude. 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. A corollary is that the commissioner should probably not aspire to higher political positions in government Doing the job right makes plenty of enemies.