Diagnostics & Imaging Week Washington Writer

WASHINGTON – Newly named acting FDA Commissioner Andrew von Eschenbach has temporarily dropped his post atop the National Cancer Institute (NCI; Bethesda, Maryland) as he takes over the reins at the federal regulatory agency. He also has said he would recuse himself from FDA work that could be a conflict of interest.

His decision to depart as NCI director came after criticism, editorially and at higher government levels, of his initial plan to manage both, including displeasure voiced by Sens. Edward Kennedy (D-Massachusetts) and Barbara Mik-ulski (D-Maryland). Both sit on the Senate Committee on Health, Education, Labor and Pensions (HELP), which oversees the FDA.

In a letter to the secretary of the Department of Health and Human Services, Michael Leavitt, Mikulski said she had “significant yellow flashing lights about the appointment of an acting commissioner who would only work part time at the FDA.”

While she and Kennedy have since said they are encouraged by von Eschenbach’s decision to work solely as the FDA’s head, they also expressed displeasure with his interim status in that position. Mikulski’s letter to Leavitt noted that it “is important to have a full-time, permanent FDA commissioner who is competent and has no conflict of interest.”

Similarly, Kennedy issued a statement saying that von Eschenbach’s decision “does not go far enough.” He added that by taking on the acting commissioner role while temporarily suspending management at the NCI “means that key health priorities important to the American people will lose out – either [an] drug safety or cancer research or both.”

Amid such criticism of von Eschenbach, there has been a continued flap over his FDA predecessor, Lester Crawford. Kennedy and Sen. Mike Enzi (R-Wyoming), who heads the HELP committee, have called for a formal government investigation of Crawford’s surprise departure of less than two weeks ago. The lawmakers also have questioned the thoroughness of the Bush administration’s vetting process.

There have been allegations that Crawford failed to disclose financial conflicts of interest. His tenure as the FDA’s top dog included various controversies such as safety oversight issues, the agency’s failure to act on an application for over-the-counter use of the prescription-only Plan B contraceptive product, last year’s flu vaccine shortage and unfounded accusations of an extramarital affair with a female staffer.

But the financial conflict charges are drawing the most attention, although Crawford has publicly denied any such wrongdoing. Still, a range of questions remain in the wake of his hasty departure, just two months after finally receiving Senate confirmation, prompting the inquiries.

MDUFMA stakeholder meeting set

The FDA reported that the third annual stakeholder meeting on the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) will take place Nov. 17 at the Gaithersburg Hilton, Gaithersburg, Maryland, from 9 a.m.-5 p.m.

Registration is required by Oct. 28, and individuals wishing to make a presentation or to speak on an issue should indicate their intent and the topic to be addressed and provide an abstract of the topic to be presented by that date.

Those interested in participating should contact Cindy Garris at cxg@cdrh.fda.gov, or 301-443-6597, extension 121.