FDA Commissioner Search On Hold Due To Political Agenda Shift
This article was originally published in The Tan Sheet
Executive Summary
The search for a new FDA commissioner appears to be on hold indefinitely in light of the national focus on counterterrorism.
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The search for a new FDA commissioner appears to be on hold indefinitely in light of the national focus on counterterrorism. HHS Secretary Tommy Thompson is understood to have told representatives from various Washington, D.C. trade associations the week of Sept. 17 that the Bush Administration will not be offering a nomination before the end of the 2001 congressional session. Thompson spoke with the heads of the Pharmaceutical Research & Manufacturers of America (Alan Holmer), the Biotechnology Industry Organization (Carl Feldbaum) and AdvaMed (Pam Bailey) in a recent closed-door session. The meeting was held to discuss issues that could affect medical products manufacturers in the wake of the Sept. 11 terrorist attacks. Domestic political agenda items have taken a back seat to national security topics following the attacks in New York and Washington, D.C. One practical difficulty in moving ahead with an FDA commissioner nomination is that the Federal Bureau of Investigation, which has to conduct background checks on all potential nominees, is devoting all available resources to its investigation into the attacks. One idea that has been floated following the meeting is the possibility of a recess appointment. The Administration appeared close to nominating Transkaryotic Therapies Senior VP-Administration & General Counsel Michael Astrue this summer, until Sen. Edward Kennedy (D-Mass.) objected to the selection of someone closely tied to the regulated industry. The current transition period is the longest for FDA under a new president since 1969. However, only two FDA commissioners (David Kessler and Jane Henney) have been appointed since the position was made subject to Senate confirmation. Both were appointed outside of the post-election presidential transition timeline. In the last two cases where an incoming Administration sought to replace the incumbent commissioner, the process was complete by the end of April (Arthur Hull Hayes in 1981 and Donald Kennedy in 1977). The only comparable timeline for a transition at FDA at the outset of a new Administration was in 1969, when the Nixon White House replaced Herbert Ley with Charles Edwards in December after a long period of uncertainty. The selection essentially marked the first time the commissioner slot was treated as a political appointment (see box, below). |