The pharmaceutical industry has an unusual new ally in its effort to achieve some of its goals during the presidential transition: Rep. Bart Stupak, D-Mich.

Stupak, chairman of the House Energy and Commerce Oversight and Investigations Subcommittee, is not traditionally a friend of drug firms, but they seem to agree on the need for a quick nomination of someone to be FDA commissioner.

In a Dec. 3 letter to President-elect Barack Obama, Stupak suggests that no current senior FDA employee should be put in the corner office at the agency, even on an interim basis.

If Obama heeds Stupak's advice to forego an insider as a temporary fill-in when Commissioner Andrew von Eschenbach departs, there is more urgency to the nomination process since finding an outsider to serve on an interim basis is highly unlikely.

Stupak's letter seems directed at CDER Director Janet Woodcock, who is often mentioned as a dark horse commissioner candidate, and Chief Scientific Officer Frank Torti, who seems positioned to head the agency on an interim basis.

The pharmaceutical industry has also been pressing the transition team to pick a leader for FDA - but it is not ruling out any internal candidates and approaches the argument differently than Stupak.

While industry says the agency needs strengthened leadership, Stupak is pushing for "a complete change in the FDA's leadership."

Current senior management is too close with the industries they regulate to effect meaningful reform of the agency, according to Stupak's letter.

Other House members share Stupak's views on FDA management, but no one was asked to add his or her name to the letter, according to an aide to the congressman.

Stupak's stance seems "indicative of where probably a number of members are," noted William Hubbard, a former associate commissioner for policy at FDA and now a senior advisor to the Alliance for a Stronger FDA.

Stupak's skepticism about current FDA leadership stems from 16 hearings held by his panel during the past two years. These found that senior managers "blocked clinical trials, drove dedicated medical professionals out of the agency, and lined their pockets with outrageous bonuses," Stupak said.

To increase the agency's independence and stability, Steven Nissen of the Cleveland Clinic, who is himself often mentioned as a possible head of the agency, suggested that the commissioner post be reconstituted as a fixed-term position. Appointing a commissioner for a five- to six-year period that crosses over presidential terms could "insulate the FDA from politics more than it has been in the past," he said at the FDC-Windhover FDA/CMS Summit in Washington, D.C., on Dec. 4.

- Cathy Dombrowski (c.dombrowski@elsevier.com) & Dan Schiff (d.schiff@elsevier.com)

No FDAer For Commissioner, Interim or Otherwise, Rep. Stupak Urges Obama

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