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סנטורית רבופליקנית בכירה קראה אמש (ב', 24.4.06) לקונגרס להעניק סמכות גדולה יותר לארגון המזון והתרופות לצורך סקירה של תרופות לאחר שאושרו לשימוש הציבור, כשהיא מצטטת דוח ממשלתי שגילה דאגה משתמכת לבטיחות בארגון

A top Republican senator on Monday called for Congress to give the U.S. Food and Drug Administration more power to review drugs after they are approved for the public, citing a government report that found lingering safety concerns at the agency.

The report, conducted by the Government Accountability Office, said there is no clear process for the FDA to monitor products once they are sold and that the agency should have the authority to require additional, post-approval studies from drug manufacturers.

"This report identifies the kinds of problems I've been tracking and investigating for the last two years," said Senate Finance Committee Chairman Charles Grassley, who released the report. "The FDA needs to make big changes."

The Iowa Republican requested the GAO review in late 2004 after Merck & Co. Inc. (MRK.N: Quote, Profile, Research) recalled its arthritis pill Vioxx because of links to heart problems.

The FDA has also been criticized for its handling of other safety issues, including antidepressant use among children and teenagers amid evidence it may cause suicidal behavior.

"FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues," the GAO report said. "We observed that there is a lack of criteria for determining what safety actions to take and when to take them."

The FDA sometimes approves products under the condition that companies later provide more data, but it lacks the authority to require such studies in most cases. The GAO said longer trials after approval could "answer safety questions about risks associated with the longer-term use of drugs."

SENATE LEGISLATION

Grassley's committee oversees the federal Medicare and Medicaid insurance programs that pay for FDA-approved medications and devices. He urged the Senate to consider his legislation to bolster the agency's review power.

Grassley has also investigated several agency decisions, including approval of Cyberonics Inc.'s (CYBX.O: Quote, Profile, Research) VNS Therapy device for depression and a controversial trial of Northfield Laboratories Inc.'s (NFLD.O: Quote, Profile, Research) experimental blood product.

Wyoming Republican Sen. Mike Enzi, head of the Health, Education, Labor and Pensions Committee that has jurisdiction over Grassley's bill, said he and Massachusetts Democratic Sen. Edward Kennedy were planning to introduce their own "comprehensive drug safety legislation soon."

FDA spokeswoman Susan Bro said the FDA was already addressing some of the report's findings.

"The FDA welcomes the GAO report and is currently leading a comprehensive and urgent effort to transform the methods our medical and scientific staff use to manage safety issues associated with prescription medicine use in the U.S.," she said.

The agency has taken some steps to address drug safety, including setting up a drug safety board. Still, the GAO found those measures "will not address all the gaps we identified."

The GAO reviewed agency documents and interviewed current and former FDA officials as well as outside experts. It also examined case studies of several approved drugs.

FDA's drug safety review process has been a concern for decades, the report said, but it came under renewed debate in 1992 when Congress began requiring drug companies to pay a fee for each new drug submitted for review.

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