FDA: Play Key Role In Success Of Drug Development Strategy
A special report in today's USA Today discusses the Food and Drug Administration's role in the development of a new generation of drugs designed to attack the root causes -- rather than the symptoms -- of disease. According to pharmaceutical firms, the shift from treatment-focus to prevention-focus means they are seeking FDA approval for "a growing number of new drug applications." Eve Slater, a vice president at Merck, said, "Everyone's trying for at least one (approval) a year. Scientifically speaking, that's hard to do." USA Today reports that since 1991, only the largest companies have averaged more than one approval per year, while others "go years between major drug approvals." Large companies such as Bristol- Myers Squibb and Johnson & Johnson are awaiting as many as four new approvals this year. Alan Holmer, president of the Pharmaceutical Research and Manufacturers Association, noted, "The process is working more efficiently now. [It] has gone down from about 30 months in 1992 to about 15 months in 1997." The increased efficiency is due in part to a proliferation of "user fees" paid by drug companies to the FDA. Some $327 million has been paid, enabling the FDA to hire 600 new employees in its drug approval sector. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said, "Our review times are going to be 10 months for standard drugs and six months for priority ones. That's a very short time." She added, "This is 20 to 30 years of investment in science by the nation starting to pay off. We will see the fruits of this" (Levy, 11/24).
Business Week On Generics
The current issue of Business Week discusses the efforts of the large pharmaceutical companies to delay approval of generic drugs. Schering-Plough, for one, developed a new tactic for Claritin, its blockbuster allergy drug. Four years after filing the patent for Claritin, "Schering applied for a second patent to cover a key biological spin-off of Claritin -- the molecule formed as the body is breaking down the drug, called a metabolite. ... That means competitors might have to come up with a generic compound that is metabolized in a completely different way -- an extremely difficult task." Even if the patent does not withstand legal scrutiny, Schering-Plough will have succeeded in delaying generic approval for about 30 months (Barrett, 11/30 issue).