Word: fda
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...succeed, go back to the laboratory. That is what Genentech (1986 revenues: $134 million) must do now that the Food and Drug Administration has at least temporarily rejected t-PA, the company's revolutionary new, genetically engineered drug that dissolves blood clots, which often lead to heart attacks. The FDA asked South San Francisco-based Genentech to come up with further test data in support of the company's claim that the drug can increase the survival rate of heart-attack victims...
...been going to Mexico to obtain drugs not approved by the Food and Drug Administration. The agency may have slowed the traffic last week by ruling that experimental drugs will be made more quickly available to patients with "immediately life-threatening diseases." AIDS sufferers could be affected, although an FDA source noted that as yet the agency knows of no drug qualifying under the ruling...
...Procter & Gamble dispatched a truck from its Cincinnati headquarters to the Food and Drug Administration in Washington. Its carefully guarded cargo: 30,000 pages of documents detailing tests of a new cholesterol- and calorie- free fat substitute that P&G calls olestra. The shipment included a petition asking the FDA to consider approving the substance's use in deep- fried foods, oils, shortenings and salty snacks...
...conduct its own tests and allow fake fat to reach menus and supermarket shelves. But Wall Street is already optimistic that the maker of Ivory soap, Crest toothpaste and Crisco oil has its hands on the greatest food-industry breakthrough since, well, sliced bread. Within two days of the FDA filing, P&G shares jumped 10%, to 93 5/8. P&G (1986 revenues: $15.4 billion) has "hit a grand-slam home run," says Hercules Segalas, an analyst for the Drexel Burnham Lambert investment firm. "This is going to be the single most important development in the history of the food...
...FDA officials defend their record, noting that all AIDS drugs have been placed on a special fast track. Retrovir went from initial clinical testing to final approval in less than 21 months, in contrast to the usual 8.8 years. Last month the agency proposed rules that would allow doctors to use experimental drugs in life-threatening situations. Says Young: "That is a breakthrough. It's a very propatient orientation...