Rep. Stupak Calls For FDA Commissioner To Resign Amid Recent Prescription Drug Safety Issues

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharmacy / Pharmacist
Article Date: 18 Feb 2008 - 6:00 PDT

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House Energy and Commerce Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) on Thursday called on FDA Commissioner Andrew von Eschenbach to resign, saying that he had lost confidence in officials over the handling of investigations and oversight by the agency, the AP/Los Angeles Times reports (Thomas, AP/Los Angeles Times, 2/15). Stupak said his call for von Eschenbach to resign was spurred in part by the recall of the blood thinner heparin, manufactured by Baxter International, which has been linked to 350 reports of adverse events since the end of last year. According to Stupak, Baxter announced the recall on Jan. 25, 2007, but FDA did not send out its own notice until Monday (Edney, CongressDaily, 2/15).

In addition, Stupak and House Energy and Commerce Committee Chair John Dingell (D-Mich.) this week threatened to hold HHS Secretary Mike Leavitt in contempt because he refused to turn over subpoenaed documents that were used to prepare von Eschenbach for a hearing last year. Stupak alleged that FDA knew that a key safety study of the Sanofi-Aventis antibiotic Ketek contained faulty data but approved the drug anyway. At the hearing, von Eschenbach testified that FDA did not use the flawed safety study to approve the drug.

Stupak said von Eschenbach should step down because "it's just a total lack of leadership" (AP/Los Angeles Times, 2/15). He said, "The drug companies know that this administration ... will do nothing to them," adding, "There is no fear of the FDA." Stupak said, "With this culture with laissez faire oversight and regulation, I think they should be gone," adding, "If we get rid of them, it will put the drug companies on notice." Stupak also called for the resignations of FDA Medical Officer Janet Woodcock; Deputy Director of FDA's drug center Sandra Kweder; and FDA Associate Commissioner for Regulatory Affairs Margaret Glavin. Glavin had attempted to close 13 of FDA's food testing labs and accepted thousands of dollars in bonuses (CongressDaily, 2/15).

FDA spokesperson Heidi Rebello said that "there isn't really anything to say beyond we've been responsive to the congressman as much as possible." FDA says there was no intention to deceive anyone of the results of the Ketek study (AP/Los Angeles Times, 2/15).

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