Groups Want a Tougher FDA
Panel Considers Calls for More Agency Power
Calls for Reform continued...
Other experts told the panel during hearings that drug companies often don't publish scientific results that question a product's safety or effectiveness, skewing the doctors' and the public's perception of the drugs.
Visco backed efforts to force drug companies to register all clinical trials and to report all findings to the public. "That is not happening now," she said.
James Kotsanos, MD, head of endocrine and cardiovascular drug development for drugmaker Eli Lilly and Co., told the panel that most companies now have voluntary web sites displaying trial information and that those sites are improving. "We even have an independent auditor checking the information," he said.
The agency also does not have the right to order companies to perform safety studies on drugs already on the U.S. market. Panelists pointed to data showing companies often don't complete promised safety studies for drugs already on the market.
Committee member Bruce M. Psaty, MD, cited research showing that 827 studies made by drug companies still remain unfulfilled. He called the figure "a large percentage" of the total commitments made by companies.
Companies: We're Improving
Drug company executives said their firms are working with the FDA to improve safety monitoring but warned that giving the agency more power would slow the progress of getting new drugs to market.
"It's not at all clear that the FDA is using the tools it already has in an adequate and effective way," said Geoffrey Levitt, an attorney representing Wyeth Pharmaceuticals. Granting regulators more authority "will undermine public health by depriving patients access to new medicines."
Sidney M. Wolfe, MD, director of the health research group for the FDA watchdog group Public Citizen, told experts that more authority for the FDA was essential. Wolfe listed 13 medications that later showed severe safety problems after being approved by the agency. The drugs including the drugs Rezulin, Baycol, and Propulsid; all had to be from the market because of safety concerns.
"This is certain to continue unless some fundamental changes take place," he said.
The committee is set to conclude its investigation this summer.