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February 6, 2007
Moving Toward Greater Drug Safety
"The Food and Drug Administration is making encouraging moves to strengthen its regulation of drugs that are already on the market. But the changes fall far short of what's needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use.
The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients -- too few for many kinds of adverse effects to become apparent. Once the drug is being used by millions, the agency has limited powers to halt sales that begin to look risky.
Last September, the Institute of Medicine, part of the National Academy of Sciences, issued a report decrying the big imbalance between premarketing and postmarketing regulation. The report, which had been requested by the F.D.A., made some 25 recommendations for strengthening the agency.
The F.D.A had already been moving to strengthen its safety assessments but now has developed a more comprehensive approach. One notable venture is a pilot program to assess the safety of a few breakthrough drugs about 18 months after they are marketed. The F.D.A. will collaborate with the Department of Veterans Affairs, the Medicare and Medicaid programs, and other groups to track drugs in use. It will publish results on its Web site. Such steps should greatly improve the agency's ability to monitor the use of drugs in the real world.
Even so, Congress needs to give the agency more money and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Related from the Joint Center:
FDA New Drug Approval Times, Prescription Drug User Fees, and R & D Spending
John Vernon, Joseph H. Golec, Randall Lutter, Clark Nardinelli
Prescription Drug User Fee Acts Generate Significant Net Benefits
John A. Vernon
Posted by the Joint Center at February 6, 2007 11:06 AM
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