Congressman suggests need for new top people at FDA

WASHINGTON Due to what he called “a total lack of leadership” at the Food and Drug Administration, Rep. Bart Stupak, D-Mich., called for the resignation of commissioner Andrew von Eschenbach.

Citing what the congressman saw as oversight issues—including the approval of antibiotic Ketek, which has been shown to cause liver failure and death, and a recent report that U.S. health officials failed to inspect a Chinese factory that might have been responsible for hundreds of allergic reactions and four deaths from blood thinner heparin—Stupak spoke of his lack of confidence in the FDA during an interview with the Associated Press.

Stupak heads up a panel charged with oversight of the FDA. In a press conference Thursday, he told reporters that the panel had asked for briefings on heparin, but were informed that the agency was simply too busy. “They can’t brief us on what’s going on. Maybe it’s time that we replace the leadership there at the FDA,” he said, according to AP reports.

Earlier this week, Stupak and Rep. John Dingell, D-Mich., the chairman of the House Energy and Commerce Committee, threatened to hold Health and Human Services secretary Michael Leavitt, who oversees U.S. health agencies, in contempt for refusing to turn over FDA briefing documents subpoenaed by the committee during the Ketek probe.

The briefings in question related to a 2007 hearing to determine if the FDA had relied on a flawed Ketek study before granting its approval. Von Eschenbach had testified that his agency had not taken the study into account, but lawmakers have subpoenaed his notes in order to determine if he was lying, as Stupak has claimed.

For its part, the FDA denies any wrongdoing or deliberate deception. “There isn’t really anything to say beyond we’ve been responsive to the congressman as much as possible,” said FDA spokeswoman Heidi Rebello, according to the AP. She added that the FDA planned to brief Stupak’s staff Friday.