FDA to Create Drug Safety Director
Posted on: Monday, 8 November 2004, 15:00 CST
WASHINGTON - Buffeted by criticism, the Food and Drug Administration said Friday it would appoint a director of drug safety and take other actions to assure the safety of medications it approves.
As sick and elderly Americans competed in lotteries for scarce flu vaccine, members of Congress chided the FDA for relying on the word of Chiron Corp., the vaccine's manufacturer, rather than investigating as aggressively as British regulators.
Critics also have charged the FDA ignored risks associated with antidepressants and the blockbuster drug Vioxx, then intimidated its own reviewers when they pointed to safety problems in both cases.
The Senate Finance Committee, one of three Congressional panels investigating the FDA, sought from the agency Friday a year's worth of correspondence between the agency and Merck & Co. Inc., Vioxx's manufacturer. Investigators suspect the agency crumbled under intense lobbying and placed cardiovascular risks less prominently on Vioxx's label in 2002.
"The warning is in there. It's a matter of whether it's effective or effectively buried," a committee aide said. FDA spokeswoman Kathleen K. Quinn, who provided by e-mail a copy of the letter from Sen. Chuck Grassley, R-Iowa, the committee chairman, declined comment.
Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, told reporters the highly publicized disagreements on Vioxx and antidepressants were uncommon. The episodes don't merit tweaking the agency's culture to ensure dissenting views are heard.
"It's a rarity. It doesn't represent the culture, so we don't really think there is a need for an overwhelming cultural change," Galson said.
However, Dr. Eric Topol, the Cleveland Clinic cardiologist who pointed to increased cardiovascular risks with Vioxx in 2001, said he's spoken to at least three other FDA researchers who complained the agency minimized their concerns about the drug.
"There has been a climate there ... of suppression of ideas and concerns," Topol said.
Lester M. Crawford, acting FDA commissioner, said the agency's stamp of approval means American drugs are the world's safest. "The measures we are taking are designed to strengthen this quality as well as our consumers' confidence that FDA's processes ensure the highest protection of the public health," he said.
Galson said the FDA will name a director of the Office of Drug Safety, vacant since October 2003, to oversee the safety of drugs after their approval. In addition, the agency is asking the Institute of Medicine to study whether improvements are needed to tease out more about a drug's side effects as it comes into more widespread use.
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U.S. Food and Drug Administration
Source: Advocate; Baton Rouge, La.
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