Idea of Drug Safety Office Is Already Hitting Snags
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Despite calls from medical experts and a prominent Republican senator for an independent office to monitor drug safety, the idea, prompted by the Food and Drug
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Washington --- The Food and Drug Administration, accused in recent weeks of being cozy with the pharmaceutical industry, must open its practices to greater public scrutiny, says a top official of the agency&#39;s besieged Office of New Drugs.
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Bulging costs keep the drugmaker from showing a profit.
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Safety problems with Vioxx could have been detected in months rather than years if the Food and Drug Administration had been able to sift through health-care information already compiled privately on one in three Americans.
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The Food and Drug Administration lacks clear regulatory authority and is chronically underfunded, shortcomings hindering its ability to evaluate the safety of drugs used by millions of Americans, according to outside scientists the agency asked to critique its performance.
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Calls for changing the way the government monitors drug safety erupted Friday, as consumer advocates and worried patients zeroed in on testimony that five federally approved medicines posed significant health risks.
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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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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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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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In a sharp change of direction, many medical authorities are questioning the safety of American drugs. In a challenge unthinkable even two months ago, Dr.
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Just as the Enron scandal triggered an overhaul of corporate accounting practices, the nation's prescription drug crisis may prompt a sweeping revamp of the way the Food and Drug Administration ensures drug safety, some say.
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The drug maker's difficulties are evident, but its productivity may make it worth a second look.
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Government drug-buying agency Pharmac wants drug companies to act more swiftly when concerns are raised over potential side-effects of their drugs, and to be responsible in promoting their products.
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About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency&#39;s monitoring of the safety of prescription
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The pharmaceutical industry and Madison Avenue are increasingly concerned about their ability to continue to pitch prescription drugs at patients and doctors.
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Two years after the withdrawal of the painkiller Vioxx, federal health regulators still lack the resources necessary to track the safety of new drugs and respond quickly to any problems that might crop up, a panel of experts said Friday.
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Description: Faced with a series of major lapses in drug safety, the Food and Drug Administration announces new measures to rectify the situation.