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FDA commissioner search should not be limited to MDs, PhDs, ex-FDAer Peck writes.

This article was originally published in The Tan Sheet

Executive Summary

FDA COMMISSIONER SEARCH SHOULD NOT BE LIMITED TO MDs AND PhDs, CARL PECK, MD, a former director of FDA's Center for Drug Evaluation & Research, suggests in a recent letter to HHS Secretary Donna Shalala."I expect that a dominant issue in your mind is whether a medical degree or a PhD degree is a necessary educational prerequisite for the commissioner of FDA," Peck writes. "From my experience at FDA and my awareness of its present and future challenges, I believe that the next commissioner should first and foremost be a highly effective manager and leader to be able to guide significant changes that will enhance the agency's dual mission of protection and facilitation of the public health."

FDA COMMISSIONER SEARCH SHOULD NOT BE LIMITED TO MDs AND PhDs, CARL PECK, MD, a former director of FDA's Center for Drug Evaluation & Research, suggests in a recent letter to HHS Secretary Donna Shalala."I expect that a dominant issue in your mind is whether a medical degree or a PhD degree is a necessary educational prerequisite for the commissioner of FDA," Peck writes. "From my experience at FDA and my awareness of its present and future challenges, I believe that the next commissioner should first and foremost be a highly effective manager and leader to be able to guide significant changes that will enhance the agency's dual mission of protection and facilitation of the public health."

"This will necessitate a broad understanding and experience in all aspects of FDA activities," Peck continues, "ranging from foods and nutrition, biotechnology, human and animal drugs and medical devices. Neither the MD degree nor the PhD degree per se guarantee such a background."

"I urge you to carefully assess the full education and experience of qualifications of all candidates to insure that their knowledge is sufficiently broad to take in stride the wide variety of technical, social and political issues inherent in guiding the agency's regulation of this range of food and medical products," Peck concludes. CDER director from 1987 to 1993, Peck wrote the letter in support of the candidacy of D.C. food and drug counsel Frank Sasinowski ("The Tan Sheet" Jan. 6, p. 19).

Former HHS Assistant Secretary for Health Philip Lee, MD, one of the participants in the process of defining appropriate qualifications for the FDA commissioner search, is understood to have advised that a medical degree not be considered a prerequisite. Lee also is understood to not be directly involved in the process of interviewing and winnowing a list of candidates.

White House Deputy Assistant for Health Policy Development Chris Jennings indicated May 19 that the Clinton Administration has not settled upon a specific profile for the new commissioner.

"FDA is now in search of a new commissioner, and I, for good or for bad, am a part of that process," Jennings told the annual legislative conference of the National Community Pharmacists Association (formerly NARD). The FDA leadership position, Jennings suggested, is "probably one of the most important political slots in the whole government. Because that person is critically important, we are spending a lot of time trying to evaluate the type of person that we want."

"I can tell you, having had hours and hours of discussion, that there is no person who is the perfect person, because we all have in our minds who that should be," Jennings added. He asked rhetorically: "Should it be a doctor, should it be a lawyer, should it be a great manager, should it be a great visionary, should it be a man, should it be a woman, should it be a pharmacist, should it be whatever."

Jennings declined to suggest a timeline for the commissioner search: "I think the Administration continues to believe that that vacancy is one of our highest priorities to fill in the relatively near future, but we need to balance that against the need to make sure that we have the best person for the job. We still have a little ways to go." When asked whether the Administration has developed a short list of candidates, the senior White House aide responded that "there are a lot of people who are under consideration, and there have been lots of lists, but there is not a list."

One possible commissioner candidate, heart surgeon and device researcher Steven Phillips, MD, Iowa Heart Center, offered some thoughts on the dissemination of medical information at a May 13 meeting of the National Library of Medicine Board of Regents ("The Tan Sheet" March 31, p. 21). Phillips voiced his support for changing NLM's Medline database from a fee-based service to a free-access system, a move scheduled to occur over the next 12 to 18 months.

Phillips called the move toward free access "timely," especially given the spread of unregulated alternative medicine. Consumers will have easy access to "real information," he said, "instead of all this hype." The Board of Regents voted unanimously to endorse the switch to a free service in what was Phillips' last meeting as chair.

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