Drug Safety Panel Is Criticized
Efforts to Protect Consumers at Risk, Say Senator, FDA Official
By Marc Kaufman
Washington Post Staff Writer
Wednesday, June 8, 2005; Page A05
The new drug safety board established by the Food and Drug Administration to restore confidence in the nation's drug supply will actually set back efforts to improve the safety of the medications Americans take and will not make it any easier to take dangerous drugs off the market, an FDA whistle-blower and a key senator said.
FDA safety officer David Graham said that after reviewing the makeup and structure of the Drug Safety Oversight Board, he concluded that the panel is "severely biased in favor of industry" and that "the FDA cannot be trusted to protect the public or reform itself."
"Ironically, drug safety in the U.S. is worse off today than it was in November," Graham added in an interview. That was when Graham, a longtime FDA safety reviewer, sharply criticized his agency's record during a Senate Finance Committee hearing into the abrupt withdrawal of the arthritis painkiller Vioxx after a study found it had harmful heart effects.
Today, committee Chairman Charles E. Grassley (R-Iowa) plans to issue his own critique of the board. In a letter to acting Commissioner Lester M. Crawford, Grassley said that the makeup of the safety oversight panel led him to conclude that "what we have here is nothing more than the status quo."
Grassley's and Graham's criticisms indicate that Congress may not be satisfied with the FDA's steps and may press for action on pending legislation to create a more independent drug safety office....
http://www.washingtonpost.com/wp-dyn/content/article/2005/06/07/AR2005060701739.html