NEW LEADERSHIP, SAME PROBLEMS FOR DODD-ENZI DRUG SAFETY BILL, SOURCES SAY
While the climate for drug safety reforms was thought to have improved with Democrats' takeover of both chambers of Congress, the obstacles remain the same for drug safety legislation recently introduced by Sens. Chris Dodd (D-Conn.) and Chuck Grassley (R-Iowa), sources say.
The senators introduced the "Food and Drug Administration Safety Act of 2007" Jan. 31. The legislation would establish an independent Center for Postmarket Drug Evaluation and Research 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 bill "will bring a new level of priority and independence to the postmarket surveillance of drugs," Dodd said. "A crisis of confidence in the FDA currently exists. If we are to restore public confidence in the words 'FDA approved,' we must ensure that the men and women who diligently monitor drugs on the market have the resources, the independence and the authority to do their jobs effectively."
The bill mirrors language introduced by the senators last session. But that legislation languished in the Republican-controlled Senate, with former Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) opposing the creation of a new drug safety office. Enzi's position was that the FDA is already structured to handle drug safety issues.
Several sources have said that Democratic leadership is more amenable to drug safety reforms. But Sen. Edward Kennedy's (D-Mass.) new role as chairman of the HELP committee means that previous opposition to the Dodd-Grassley bill is unlikely to change, Mark Cohen, director of the Government Accountability Project's Food & Drug Safety office, said.