Word: generic-drug
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Kessler is waging a crusade well suited to the 1990s: it involves no new money. In fact, during the past decade the FDA has been given a host of new and taxing responsibilities, including the oversight of the generic-drug industry, the evaluation of hundreds of AIDS treatments and now the redesigning of food labels. Yet the agency's budget has not increased proportionally. "We've had to divert people from laboratory work, and we've brought people in from the field," says Ed Scarbrough, the chief architect of the FDA's new labeling program. He believes that the task...
...almost certainly the most capable person ever put in charge of the Food and Drug Administration. It is not a post that most folks would relish. When Kessler was appointed last December, he faced an agency that for more than a decade had been bled of funds by the White House and burdened with new responsibilities by Congress. AIDS activists were picketing the front doors because of the FDA's sluggish pace in approving drugs. Five employees had been convicted of accepting bribes from the generic-drug industry. There were allegations that other staffers were selling insider information about drug...
...measure proved to be only a partial solution. Last July a bribery scandal rocked the U.S. industry when three FDA reviewers pleaded guilty to accepting bribes from generic-drug companies. The revelations threw doubt on the efficacy of some generics. Meantime, drug prices continued their upward spiral -- primarily because of the fundamental forces that drive the modern pharmaceutical industry...
...result, the agency has a bad case of bureaucratic burnout. Approval of new drugs requires mountains of corporate filings, and delays in processing applications now run well over two years. That has led to more scandal: this summer investigators discovered that a few generic-drug developers had bribed underpaid FDA employees to speed up the agency's responses to the paperwork for their products. Three FDA reviewers have already pleaded guilty, and more prosecutions are expected. "This past year has been one of the most difficult in FDA's history," said Commissioner Frank Young last week...
Nike, Reebok and L.A. Gear are creating space-age sneakers in their fight for a $9 billion market. -- Payoffs and fake lab results taint the generic-drug industry...