Word: new
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Dates: during 1980-1989
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...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...
Congress, industry and consumer groups agree that something needs to be done to resuscitate the ailing agency. Young is a victim of the urge for change: last month Health and Human Services Secretary Louis Sullivan said he was transferring Young to a new post -- Deputy Assistant Secretary of Health for Health Science and Environment -- effective this week. The position was created especially for Young, and is widely regarded as a demotion...
...public health bills during the '80s, many of them efforts to shore up the FDA's powers. The action significantly expanded the FDA's workload. Yet Congress never moved to restore a single lost staff position or add employees to meet the increased responsibilities. The advent of an entirely new industry, biotechnology, demanded an FDA response to more than 950 genetically engineered products during the 1980s...
Decaying labs and desperately low salaries have made hiring another FDA travail. Some important drug-review posts have an annual turnover rate of 20%. At least one former FDA official believes many new employees use their stint at the agency to bolster resumes that are then quickly circulated to industry...
...been especially inept. Sullivan has no replacement waiting, and in fact has been unable to fill many important health jobs because White House conservatives filter out nominees with proabortion views. Pro-lifers are sure to scrutinize Young's successor closely since the agency is likely to decide on approving new abortion-inducing drugs like RU 486, the pill manufactured by a French subsidiary of Hoechst...