Senate Bill Would Create Independent FDA Drug Safety Center

The FDA would have new authority to withdraw previously approved drugs, require postmarketing clinical trials and vet direct-to-consumer (DTC) advertising under a drug safety bill introduced by two influential senators.

The Food and Drug Administration Safety Act of 2005, drafted by Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Christopher Dodd (D-Conn.), would establish an independent Center for Postmarket Drug Evaluation and Research (CPDER) to carry out a series of proposed drug safety measures. The center, which would receive $500 million over five years, would report directly to the FDA commissioner.

"The new center is needed because the existing office of new drugs is hampered by real and perceived conflicts of interest," Grassley said during a recent press conference. "If you want accountability, it doesn't make sense to have the office that reviews the safety of drugs to be under the thumb that puts the drugs on the market to begin with."

Under the legislation, the FDA's existing Office of Drug Safety (ODS) would transfer to CPDER. "The center's independence would not exist solely on an organizational chart like it presumably does right now," Grassley said of the current drug safety office. The independent center would be in a better position to regulate drugs once they're on the market, he added.