Contempt threatened in FDA oversight

A Republican congressman yesterday threatened to cite the secretary of health and human services and President Bush for contempt of Congress for not responding to a subpoena related to FDA testimony last year.

Rep. Joe L. Barton of Texas told Secretary Michael O. Leavitt that he wants briefing materials relating to Food and Drug Administration Commissioner Andrew von Eschenbach’s March testimony on the drug Ketek by today.

“I don”t want to have to stand up on the floor and support a contempt citation for you or the president, but I will,” said Mr. Barton during a House Energy and Commerce hearing into the department’s 2009 budget.

The panel’s subcommittee on oversight and investigations has been looking into Dr. von Eschenbach’s testimony on Ketek for almost a year. A whistleblower told the group that the testimony contained errors and misleading statements.

The subcommittee says Mr. Leavitt and the FDA haven’t adequately responded to its requests for data. It issued a subpoena for Dr. von Eschenbach’s briefing papers Jan. 29.

The makers of the antibiotic Ketek, a company called Sanofi-Aventis, have been questioned about fraudulent clinical trials. The subcommittee has questioned whether the FDA should have detected problems before it approved the antibiotic, used to treat infections, in 2004. Ketek has caused liver damage in some patients.

Mr. Leavitt responded earlier this month that the briefing materials are “confidential and deliberative materials,” and that exposing them would disrupt the open dialogue in the agency.

That argument didn’t sit well with the subcommittee. Members told Mr. Leavitt he had two days to come up with the materials or agree to let the committee interview the FDA employees, according to a letter signed by Reps. John D. Dingell and Bart Stupak, Michigan Democrats; John Shimkus, Illinois Republican; and Mr. Barton.

Mr. Leavitt said yesterday he was “optimistic” the issue would be resolved.

Also at the hearing, Democratic lawmakers questioned the Bush administration”s funding for HHS, specifically Medicare and the FDA.

“It’s clear that Congress is going to have to adjust the president’s budget proposals,” said Rep. Henry A. Waxman, California Democrat.

“The most that any agency can hope for in this budget is to be flat funded.”

Democrats argued that considering inflation, the HHS budget barely increases, despite additional demands on the agency to fund Medicare and watch the nation’s food and drug supplies.

Mr. Waxman and others pointed to a recent report from the FDA Science Board, an advisory group, that said the FDA needs seven times the amount Mr. Bush has proposed if it is to adequately fulfill its duties, including high-profile ones such as protecting the nation’s food supply and drug imports.

Mr. Leavitt called the budget “an important step forward” to meeting funding demands and balancing the president’s budget.