FDA chief is urged to resign

A key House Democrat said Thursday that the head of the Food and Drug Administration should resign in light of a probe over an antibiotic and news of a blood thinner linked to allergic reactions and four deaths.

Rep. Bart Stupak (D-Mich.), who heads an investigative panel overseeing the agency, said FDA Commissioner Andrew C. von Eschenbach should step down because “it’s just a total lack of leadership.”

Stupak, a member of the House Energy and Commerce Committee and head of its oversight panel, said he had lost confidence in the commissioner and other top FDA officials over the handling of inspections and oversight by the agency.

FDA spokeswoman Heidi Rebello said that “there isn’t really anything to say beyond we’ve been responsive to the congressman as much as possible.”

Stupak’s panel has investigated a Sanofi Aventis antibiotic called Ketek that was linked to death and liver failure in 2006.

Stupak has alleged that the FDA approved the antibiotic despite knowledge that a key safety study of the drug was plagued by faulty data.

Earlier this week, Stupak and Rep. John D. Dingell (D-Mich.), chairman of the energy and commerce committee, threatened to hold Health and Human Services Secretary Mike Leavitt in contempt for refusing to turn over FDA briefing documents subpoenaed by the committee. Leavitt oversees the FDA and other health agencies.

The documents were used to prepare Von Eschenbach for his appearance before House lawmakers last year. The commissioner testified that the FDA did not use the flawed safety study to approve Ketek. But Stupak has called that statement untrue and subpoenaed Von Eschenbach’s notes to determine whether he lied under oath.

The agency has said there was no intention to deceive.

Sanofi Aventis has said one of its predecessors, Aventis, was not aware of fraud connected with a key Ketek study until after the study was submitted to the FDA.

Stupak also said he was dismayed to learn this week that U.S. health officials had not inspected a Chinese factory that may be the source of problems with a Baxter International blood thinner tied to hundreds of reports of allergic reactions and the four deaths.

The FDA wants to inspect the facility as soon as possible and has requested its inspection data and other reports.

Baxter has said it buys the active ingredient for heparin from a supplier that manufactures it at the Chinese factory and at a U.S. facility.