Word: agouron
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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...
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...
...newly greased skids can improve not only the health of 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...
They got some incentive two weeks ago, when the FDA approved for the first time the use of two protease inhibitors for children--Agouron's nelfinavir and Abbott's ritonavir. But parents and pediatricians complain that they still don't have enough information about how to use them. Nelfinavir, in particular, "went through the approval process very rapidly," says Dr. Mark Kline, associate professor of pediatrics at Baylor College of Medicine in Houston. "There are some basic pieces of information about nelfinavir that we don't have--like how often to give the drug or in what dose...
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