FDA Approving Medicines at ‘Regular’ Speed
Despite charges from some pharmaceutical manufacturers that the FDA has been slow in approving new medications, and accusations from consumer groups that the agency has endangered the public with speedy drug approvals, "the latest government records" show that the FDA approval rate is normal, the AP/Contra Costa Times reports. Government figures indicate that "breakthrough" medications are "still speeding through" the FDA. For example, the leukemia treatment Gleevec was approved in less than three months, a record time for the FDA. While total approval time for drugs did increase four months last year, the AP/Times reports that the statistics were "skew[ed]" by "long languishing products" such as RU-486, which was not approved for four years. Also, approval times increased because manufacturers are submitting fewer "novel medicines" and more "me-too" drugs -- which make only slight changes on an existing drug -- for approval. Under federal law, the FDA has longer to review drugs that have an equivalent already on the market. Approval time for biotechnology drugs, which are more "complex products," have also taken more time to be approved than "regular pharmaceuticals." Median times for biotech approval increased from 11.5 months in 1998 to 16.5 months in 1999, the AP/Times reports. Robert Yetter, chief of biotech review at the FDA said the "jump" in 1999 was caused by companies submitting applications for approval for drugs that were not "properly studi[ed]." According to a study by the investment research company UBS Warburg, the FDA is taking a "tougher stance" on safety issues. However, the study also said that "it could be argued that companies had been adopting a more laissez-faire attitude with the FDA," as it is "easier to blame the FDA" for slow approvals "than admit that the clinical information submitted was not adequate" (Neergaard, AP/Contra Costa Times, 8/20).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.