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Lawmaker Chides FDA Head on Drug Oversight

Apr 23, 2008 | Parker Waichman LLP Representative John D. Dingell, Democrat-Michigan and chairman of the House Energy and Commerce Committee, has long been unhappy with the U.S. Food and Drug Administration (FDA) and its commissioner, Andrew von Eschenbach.  Dingell recently accused von Eschenbach of not doing his job in regards to drug safety, and has repeatedly asked the FDA chief how much it would cost to do more inspections of foreign drug makers.  The commissioner still has not provided specifics.

Dingell and other lawmakers said the FDA must conduct more inspections of companies sending drugs to the U.S. to ensure they are safe, citing deaths and allergic reactions linked to contaminated versions of the blood-thinner heparin from China as well as a host of other tainted products, including toothpaste, that were shipped to the U.S. “You cannot do your job, you are not doing your job,'' Dingell told von Eschenbach, who was a witness at the hearing before the energy and commerce panel's investigations subcommittee.  “You simply are absolutely incapable of addressing your responsibilities.''

Earlier this year, Representative Bart Stupak said that 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—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 called for the resignation of von Eschenbach and other top officials.

Von Eschenbach, who was confirmed to lead the FDA in late 2006 argued that the FDA is doing more overseas inspections than ever before and acknowledge that more is needed and the U.S. must take other actions, adding that more frequent inspections wouldn't have detected the tainted heparin—in which 81 died and hundreds more were sickened—because even if an inspection had taken place, the contaminant wouldn't have been found because conventional tests couldn't have detected it. The FDA has since asked drug makers to use a test that can pick up the contaminant.  “In addition to addressing the need to increase our inspections we also need to overhaul the entire system,'' von Eschenbach said.  The FDA is trying to improve the safety of drug imports by increasing collaboration with regulators overseas and stationing agency employees in China and other countries, he said.

The FDA conducts annual inspections of about seven percent of overseas drug makers that ship to the U.S., which means, at this rate, it will take 13 years to visit them all, according to the Government Accountability Office (GAO)—the investigative arm of Congress.  Domestic firms are inspected about once every 2.7 years.  Meanwhile, no less that 80 percent of all active ingredients used by U.S. manufacturers to produce drugs are imported.  The entire U.S. budget for inspecting overseas drug makers is not large enough to check all of the plants in China—which has the largest number of plants registered to send drugs to the U.S.—every two years, according to an analysis released today by the GAO.

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