Word: fda
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Late last week, however, the FDA bucked its own bureaucratic tradition when one of its advisory committees recommended that a similar drug made by Bristol-Myers Squibb, called DDI, or dideoxyinosine, be put on the market even though it has not undergone the agency's standard testing. While the decision heartened many AIDS organizations, some desperate patients have resorted to an immediate alternative: black-market DDC. Underground AIDS groups are buying the drug in bulk directly from chemical companies, which manufacture it for use in laboratory experiments. The clandestine suppliers then weigh out and package the counterfeit pills and sell...
...access to the experimental drug is strictly limited, and for years desperate families have been pressing the Food and Drug Administration to make it widely available. Last week an FDA advisory panel issued a strong rebuff. After reviewing all the clinical studies, the panel agreed 8-0 that tacrine "did not show a clinically meaningful benefit." Moreover, the danger of its causing liver damage is significant, the group said...
...tacrine controversy underscores one of the most vexing of medical issues: should the regulatory process be eased for drugs aimed at deadly diseases that do not respond to any other treatment? Vigorous lobbying by AIDS activists has led the FDA to expedite release of two drugs that appear to alleviate symptoms of that fatal infection. Inspired by that example, families of Alzheimer's patients have been demanding similar treatment...
While both the White House and Congress are pleased by his performance so far, FDA watchers outside government are skeptical that he will succeed in reversing the fortunes of his agency. "You can deal with orange juice easily, but pretty soon you've got to get down and deal with the real inadequacies," says Charles Edwards, a former FDA commissioner who chaired the government panel that examined the agency's shortcomings. The food industry believes Kessler is pushing too far, too quickly. Consumer activists are waiting to see what he will do about a range of food-safety issues, such...
...FDA wants you to know exactly what's for dinner...