Word: fda
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Dates: during 1980-1989
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...readily available by speeding up the Government-approval process, competition has skyrocketed -- and so has the opportunity for abuse. Now a yearlong investigation by the Justice Department and the Food and Drug Administration is uncovering evidence that some makers of generic pharmaceuticals falsified laboratory test results and paid off FDA chemists to gain quick Government approval for their products. While no drugs have been found so far to be harmful or ineffective, the fraud is shaking the reputation of the $7 billion generic-drug industry...
Hastening to restore confidence in its imprimatur, the FDA last week launched a crash program to re-evaluate 30 of the most commonly prescribed generic medications, including such prevalent antibiotics as ampicillin and oral penicillin. Over the next six weeks, the agency will test more than 1,000 samples to make sure they are biologically equivalent to their brand-name counterparts. In addition, the FDA, which had cut back its commercial inspections because of budget restraints, announced that it will hire more field inspectors and seek tougher punishments for unscrupulous manufacturers...
...cereal General Mills introduced in May. Psyllium is also found in Metamucil, one of P&G's fiber laxatives. But while General Mills is allowed to advertise that Benefit helps to reduce cholesterol, P&G is forbidden to make the same claim for its laxative unless it can get FDA approval, which P&G has tried but failed...
...urged the FDA to order the cereal off the market. But General Mills, which has limited Benefit's sales mostly to the Midwest, intends to fight back. Says a spokesman: "There's no question that it's a food and not a drug. It's packaged like a cereal, it looks like a cereal, and it's sold like a cereal...
...wealthy or the well insured to receive the drug. Some state Medicaid programs pay for AIDS treatment only when the disease is far advanced. People who take AZT to stall the onset of AIDS may not be covered. Burroughs Wellcome Co., which manufactures AZT, is now seeking FDA clearance to use the medication in pre-AIDS patients. If the Federal Government permits the number of consumers to go up, presumably the price will come down...