Saturday, November 18, 2006

Another Republican blocks Bush pick to lead US FDA

Another Republican blocks Bush pick to lead US FDA
By Susan Heavey

WASHINGTON (Reuters) - Senate Finance Committee Chairman Charles Grassley has protested U.S. President George W. Bush's pick to head the Food and Drug Administration, according to a letter released on Friday, making him the third Republican lawmaker blocking the nomination.

Nominee Andrew von Eschenbach, who has served as acting FDA commissioner since September 2005, refused to cooperate with a Senate investigation into a controversial antibiotic that included requests for agency documents and staff interviews, Grassley said.

"I am extremely disturbed by the Acting Commissioner's continued failure to comply with the committee's subpoenas over the past six months," Grassley, an Iowa Republican, wrote in a November 16 letter to Senate Majority Leader Bill Frist.

A Grassley spokeswoman said the subpoenas in question were related to the FDA's 2004 approval of Sanofi-Aventis' antibiotic Ketek. The FDA said this week it would ask an outside panel of experts if Ketek should remain on the market after reports of liver failure in a dozen patients.

Ketek is used to treat chronic bronchitis and some forms of sinusitis and pneumonia. Grassley's committee has been investigating reports that some doctors studying the drug falsified data or failed to keep accurate records.

Grassley also complained that his other requests to the FDA and its umbrella agency -- the Department of Health and Human Services -- received responses an average of 101 days late.

The FDA, in a November 16 letter to Sen. Frist, said it had been "actively engaged" since Grassley made his initial request in April. According to the agency, the senator wrote the FDA 17 times, and the FDA has provided more than 100,000 pages of documents.

The FDA was continuing work on several requests but cited confidentiality concerns with others, according to the letter. It was inappropriate for Grassley to interview one staffer in question because of pending regulatory matters, it added.

"Senator Grassley's document request covered a vast number of documents from several components of FDA," David Boyer, the FDA assistant commissioner for legislation, wrote to Frist.

"Identifying, locating, gathering and reproducing the appropriate responsive documents was a time- and labor-intensive process, involving dozens of agency staff."

Von Eschenbach's nomination already faced protests from two other Republican senators.

Sen. Jim DeMint of South Carolina has opposed a confirmation vote because of concerns about the safety of the abortion pill known as RU-486, or Mifeprex, while Sen. David Vitter of Louisiana has said he will object until prescription drug imports are legalized.

The Senate Health, Education, Labor and Pensions Committee has approved Eschenbach's nomination, but individual senators can use a certain procedure to block the necessary full-Senate vote.

The FDA has not had a permanent leader for all but 18 months of Bush's nearly six years in office.

Bush tapped von Eschenbach for the permanent post in March. Two Democratic senators previously blocked his nomination but later withdrew their protests after the FDA approved access to emergency contraception without a doctor's prescription.