Word: fda
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Dates: during 1990-1999
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Still, a little de-reg can go a long way, as it has for Peter Johnson, president and CEO of Agouron Pharmaceuticals in La Jolla, Calif. Earlier this year the FDA, using a streamlined process specifically developed for life-threatening diseases like AIDS, gave a green light to Viracept, the firm's new anti-HIV drug...
...often felt like swimming through Jell-O--is both a worthy and a popular cause. The appetite for free-market trial and error is limited, however, in a business where error has sometimes meant disfigurement or death. "There's a great push to try to cut down the FDA," says Fred Dorey of the Bay Area Bioscience Center in Oakland, Calif., a trade organization for biotechnology firms. "But that's from people who don't realize there is a role for government regulation, and it's not going to go away...
Essentially, the new FDA-process fast track offers conditional approval for appropriate drugs based on clinical trials that are smaller and faster than normal. The agency also allows "rolling submissions," meaning it will accept and release initial reviews of drug components that are prepared earlier than the rest. For Agouron the difference was startling: the FDA's review of the Viracept application took a total of only 83 days; in 1992 the average length of time for FDA drug approval was 19 months...
...waiting patients but also the firm's bottom line. Agouron spent the past 12 years pumping all its income--$56 million last year--into research on the technology and procedures later used to bring Viracept to market. Agouron's net loss last year was $19.5 million, and under normal FDA review, Viracept would still not have been able to earn money for several more years. Under the new rules, however, Agouron can profit immediately from sales of Viracept, which, as one of only four protease inhibitors currently revolutionizing AIDS treatments, is sure to sell well. Viracept could earn $500 million...
Though he may make a fortune earlier than originally expected, thanks to the FDA's fast action, Johnson maintains that new drugs emerging from the biotech industry should be regulated. "I think the only legitimate discussion with regard to regulatory process is whether there is a correct and socially acceptable balance between the urgency of bringing forward a product that can help with life-threatening diseases, vs. protecting public safety," he says. "Striking that balance is a matter of public policy, and it's not a simple debate...