Qualities we'll need in the next FDA commissioner

Qualities we'll need in the next FDA commissioner

Miller Op-Ed in San Jose Mercury News
September 26, 2005

The sudden departure of FDA Commissioner Lester Crawford 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 a trillion dollars annually.<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />

 

Those with an independent streak or drug industry experience need not apply. The Bush administration will require that the new commissioner toe the party line on reproductive issues, therapeutic cloning and reimportation of drugs to the United States from abroad, while Sen. Edward Kennedy, D-Mass., the ranking member of the Senate Health, Education, Labor and Pensions Committee (which must confirm the nominee), will reject any candidate with past ties of any kind to regulated industry.

 

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.

 

•  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.

 

•  Commitment to regulatory reform. The FDA needs to streamline its 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, FDA's senior and midlevel 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 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 previous Commissioners McClellan and Crawford, 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.