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FDA Report Says Nation's Health at Risk
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Page: << Prev | 1 | 2 | 3 The report also calls for better-trained FDA scientists and improvements in the agency's computer technology. The full report will be presented at a meeting of the FDA's Science Board on Monday.
In recent years, numerous food recalls and the withdrawal from the market of popular medications -- the removal of the painkiller Vioxx in 2004 was one of the most high-profile examples -- have eroded public confidence in the FDA. A recent survey found that 47 percent of Americans rated its performance as fair or poor.
And a study published in September found the number of serious adverse drug events more than doubled between 1998 and 2005 in the United States, as did the number of related deaths. From 1998 to 2005, the number of reported serious adverse drug events increased from 34,966 to 89,842. The number of fatal adverse drug events almost tripled during the same time period, from 5,519 in 1998 to 15,107 in 2005.
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The number of adverse events increased four times faster than the total number of outpatient prescriptions, which rose from 2.7 billion to 3.8 billion during that time frame, according to the study, which was published in the Archives of Internal Medicine.
Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, called the new FDA report a "partial and simplistic view of what is wrong with the FDA."
"There seems to be more importance placed on satisfying industry [at the FDA]. It's not an atmosphere where people are free to express their differing opinions," he said.
Wolfe thinks the agency needs to be changed substantially, including new legislation that would strengthen its ability to regulate food additives, drugs and dietary supplements. He also thinks user fees should be abolished, because the fees make the relationship between the agency and drug companies too close.
More information
For more on what the FDA is doing about drug safety, visit the Food and Drug Administration.
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 12/1/2007
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SOURCES: Steven Grossman, spokesman, FDA Alliance; William Hubbard, former associate commissioner, U.S. Food and Drug Administration, and advisor, Coalition for a Stronger FDA; A. Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, and professor, health management and policy, University of Michigan School of Public Health, Ann Arbor; Sidney M. Wolfe, M.D., director, Health Research Group, Public Citizen, Washington, D.C.; November 2007, FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology
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