A House subcommittee voted to subpoena former FDA officials to answer questions about fraudulent clinical data used to approve Ketek, an antibiotic with life-threatening complications including liver failure.

The subpoena came at the end of a day when witness after witness testified that the FDA has fallen short of its oversight responsibilities to regulate and monitor food, drugs and medical devices. An outdated system of information technology, and budgetary constraints were among the factors enumerated by witnesses before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.

FDA Commissioner Dr. Andrew von Eschenbach disagreed with the critical assessments, calling the FDA the “gold standard as [a] regulatory agency.”

Several witnesses noted the agency's decline over 25 years has become more consequential now that 80 percent of pharmaceutical ingredients come from off-shore plants. At the current rate of inspecting China’s 714 factories exporting medicine to the United States, it would take roughly 40-50 years to visit them all, estimated Rep. Bart Stupek (D-MI), in one of several moments when he evidenced frustration. The agency recently announced it would open offices in China and India.

Stupak and von Eschenbach sparred verbally over the agency’s budget request for the next fiscal year, with Von Eschenbach refusing to say what he asked for. He maintained the budget amount would be in the president’s budget, which has not yet been released, for which reason he could divulge the amount. Rep. Gene Green (D-Texas) reminded von Eschenbach that he may have been named to his position by the president, but he works for the American people.

The hearings coincided with a release of a report from the GAO report discussing the FDA's inspections of medical devices.

The committee meets next on February 12.