While the FDA key positions like all other agencies are filled by appointees - I find many of the people to be career employees - MD's PhD's.
However policies seems to be coming down from the parent agency the DHHS. Well currently former EPA, Leavitt is Secretary.
Interesting, however is his deputy:
Biography of Eric D. Hargan
Acting Deputy Secretary
U.S. Department of Health and Human Services
As Acting Deputy Secretary of Health and Human Services, Eric D. Hargan is the chief operating officer of the largest civilian department in the federal government, with a budget of $640 billion and more than 67,000 employees. Working closely with Secretary Mike Leavitt, Hargan oversees all operations, including Medicare, Medicaid, public health, medical research, the regulation of food and drugs, welfare, child and family services, disease prevention, Indian health, mental health services, and many other activities. He also serves as the Regulatory Policy Officer for HHS, overseeing the development and approval of all HHS regulations and significant guidances. In addition, he leads a number of initiatives at the Department, including implementing the President’s Management Agenda, ....
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Prior to joining HHS, Hargan was a partner in the Chicago headquarters of the law firm of Winston & Strawn, where he specialized in corporate law, particularly mergers and acquisitions, securities, and venture capital transactions.
http://www.hhs.gov/about/bios/deputysecretary.htmlany thoughts?