DRUG APPROVAL: FDA Streamlining Process, Study Finds
Legislative reforms and "a change in attitude among regulators" have enabled the FDA to speed up its drug approval process, according to a new report by the Boston-based Tufts Center for the Study of Drug Development. The study notes that 108 drugs have been approved by the FDA in the past three years, "more than in any similar period since 1962." Experts say the 1992 "Prescription Drug User Fee Act" contributed to the FDA's increased efficiency because it "required companies to pay hefty fees ... to have their products reviewed." The fees "have allowed the agency to add staff that it needed for more timely product reviews," said Janice Bourque, executive director of the Massachusetts Biotechnology Council. Congress' 1997 "FDA Modernization Act" further streamlined the approval process by requiring the FDA to work closely with companies during human testing stages, a process that typically takes six years. Mark Skaletsky of Waltham, MA-based GelTex Pharmaceuticals said the FDA approved the marketing of Renagel, a "treatment for patients with kidney disease," within one year. "In the past, issues could arise between the agency and the applicant," Skaletsky stated, "In our case, though, the process was very smooth." It takes an average of 15 years and "hundreds of millions of dollars" to bring a new drug to market, the Tufts study noted (Griffith, Boston Business Journal, 8/2).
Newsletter Reports Record Low FDA Approvals
Despite the streamlining, according to the Biomedical Market Newsletter, the number of new medical products being cleared for marketing by the FDA "is apparently headed for a record low this year." The newsletter's June 30 "Annual New Product Special Issue" reports that during the most recent 10-month period, an average of 303.33 new products were approved, the first time in the last 12 years that the average per month has fallen below 400 and the average per year below 4,000. The "massive 84-page issue" lists the medical "devices, instruments, equipment, supplies, diagnostics, assays and tests" approved by the FDA in the past ten months. It can be ordered by calling 1-800-875-8181 or through the Web site www.biomedical-market-news.com (release, 8/3).