Congress Seeks to Balance Drug Safety, Quick Approval
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Three drugs -- Vioxx, Ketek and Avandia -- are casting long shadows over the congressional debate on how to update and revise the 15-year-old system that has dramatically sped up the process of bringing prescription medicines to American consumers.
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U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of a Sanofi-Aventis antibiotic and some other prescription drugs on Tuesday.
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The U.S. Food and Drug   Administration needs more staff, funding and power over the   drug industry to better police the safety of medicines after   they reach the market, an Institute of Medicine panel said on   Friday.
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Congressional pressure on drug makers and regulators mounted yesterday as the House Energy and Commerce Committee began investigating the approval and recall of Vioxx.
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Legislation meant to improve the government's drug safety oversight cleared a U.S. House of Representatives subcommittee on Tuesday without a controversial limit on television advertisements.
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The U.S. Congress on Saturday passed a bill to improve U.S. preparedness for bioterrorism or other health crises, in part by accelerating development of new vaccines and drugs.
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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of a  Sanofi-Aventis antibiotic and some other prescription drugs on  Tuesday.
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The federal Food and Drug Administration said Friday that it would strengthen its safety and review process for pharmaceuticals already on the market to learn more about their possible side effects.
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Congress has been investigating the FDA&#39;s decisions in both the Vioxx and antidepressant cases. The probes have focused on agency reviewers who warned about potential problems but claimed their research was ignored or suppressed by other officials.
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Democrats Hillary Rodham Clinton of  New York and Henry Waxman of California will introduce  legislation on Wednesday that would give the Food and Drug  Administration the legal authority to approve cheaper, generic  versions of biotech drugs known as biologics, the lawmakers  said.
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Congress ought to write a detailed prescription for change in US oversight of drug safety. The public deserves better protection from potentially dangerous new medicines.
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Three drugs -- Vioxx, Ketek and Avandia -- are casting long shadows over the congressional debate on how to update and revise the 15-year-old system that has dramatically  sped up the process of bringing  prescription medicines to American consumers.
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The report is likely to intensify a debate about the safety of the nationÂs drug supply and the adequacy of government oversight.
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WASHINGTON Nov 5, 2004 - Buffeted by criticism, the Food and Drug Administration said Friday that it would appoint a director of drug safety and take other actions to assure the safety of medications it approves.
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Federal regulators say they&#39;ve reached a balance in treating depressed kids with antidepressants that can also be dangerous. The Food and Drug Administration is now requiring all antidepressants to carry its strongest safety alert.
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With yet more already-marketed medicines raising the ire of consumer advocates and regulators alike, momentum is building for reform of the governmentâs drug approval and monitoring procedures.
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When a congressional committee holds a hearing next Wednesday, the subject will be the safety of the diabetes drug Avandia and whether federal drug regulators have paid close enough attention to its potential risks.