FDA Missteps Over Defective Drugs Draw Fire from CongressmanFeb 21, 2008 | Parker Waichman LLP
Recent scandals over tainted Baxter Heparin, Avandia, Ketek, Vytorin and other defective drugs have led many to conclude that the Food & Drug Administration (FDA) is broken. But Representative Bart Stupak (D-Mich) has argued for years that the FDA wasn't doing a thorough job protecting Americans from unsafe drugs. His concerns became personal when, in 2000, his 17-year-old son, who was using the acne medication Accutane, committed suicide. Stupak personally investigated whether the drug could be tied to psychiatric side effects.
If Americans "knew how little the FDA did to assure the food and drug supply, if the truth ever came out...people would be marching in the street," Stupak told The Wall Street Journal recently. "That's (Accutane) just one drug. There are many like that," Stupak says. Now, as the FDA is under fire for mistakes over international inspections and other issues, Stupak—an eight-term Democratic congressman and chairman of the Subcommittee on Oversight and Investigations of the House's powerful Energy and Commerce panel, which has jurisdiction over the FDA—is at the center of an aggressive effort by congressional Democrats to spotlight what they say are problems with the Bush administration's position on consumer-safety issues.
Stupak's subcommittee is probing the FDA's handling of Baxter International Inc.’s heparin, the blood-thinning drug that has been potentially linked to hundreds of patient reactions and four deaths. The subcommittee is also examining Pfizer Inc.'s Lipitor, Vytorin from Schering-Plough Corporation and Merck & Company, and anemia drugs sold by Amgen Inc. and Johnson & Johnson. Ketek, an antibiotic from Sanofi-Aventis SA, has been under review for over a year. Stupak is holding hearings on the safety of imported food, medicines, and medical devices and says he has a bigger agenda adding, that "It's a broken agency."
Stupak called for the resignation of FDA commissioner, Andrew von Eschenbach and other top officials and says that step has nothing to with partisan politics, adding that Republican Senator Tom Coburn of Oklahoma—a medical doctor—would be a good replacement. Coburn's opposition to abortion rights would make him unacceptable to many Democrats.
Democratic lawmakers are expected to pass only limited legislation this year, with the Senate divided and President Bush resisting some Democratic initiatives. Republicans complain that some of the Democrats' moves seem aimed at getting attention, such as Representative Michael Burgess, a Texas Republican and a member of Stupak's subcommittee. Burgess says he wants the FDA examined, but "sometimes it just seems like we want to call names and point fingers, not pursue solutions."
von Eschenbach, who was confirmed to lead the FDA in late 2006, says they introduced a new food-safety plan, hired a chief information officer to manage information technology issues, and are working to install inspectors in countries including China and India. The Bush administration's budget included a proposed increase for the FDA.
Stupak and Representative John Dingell, the Michigan Democrat who is chairman of the full Energy and Commerce panel, say the investigations are building a case for broader efforts to overhaul the FDA. Dingell says he plans far more ambitious FDA legislation, "The import bill is a good beginning, but it isn't far enough." Stupak says he'd like to look at granting the FDA subpoena power, regulating drug-industry consumer ads, and increasing the agency's funding.