FDA Considers Plan to Require More Tests on Environmental Effects of Pharmaceuticals in Drug Approval Process
The FDA is considering requiring more tests on the effect of pharmaceuticals on the environment during the drug approval process, the New York Times reports. The FDA's environmental testing requirements were scaled back in 1997 as part of the Clinton administration's efforts to "streamline" government regulatory processes. But the FDA is considering re-implementing more environmental tests in the wake of a study released yesterday by the United States Geologic Society that found "minute amounts" of "dozens" of antibiotics, hormones, pain relievers, cough suppressants and disinfectants, among other products, downstream from water treatment plants. The study considered more than 100 waterways in 30 states. It is not known if the products make the water harmful to people. According to the Times, estrogen and "similar compounds" have become a central focus of research by the EPA and many scientists because of "hints" that such contaminants could alter sexual characteristics in fish and other water-bound species. Approximately 40% of the waterways studied by the USGS had traces of estrogen or other reproductive hormones. Dr. Steven Galson, deputy director of the FDA Center for Drug Evaluation and Research, said, "We're looking very carefully at [the USGS study] and aren't ruling out the fact that we may have to make changes" to the drug approval process. But some scientists for drug companies say that hormones are naturally produced by humans, wild animals and some plants. "It's hard to see what we'd be able to do about that," Dr. James Hagan, vice president of corporate health for GlaxoSmithKline PLC, said, adding, "It's one thing to regulate the things we add to the environment. But some of these things have been there as long as there have been various plants around" (Revkin, New York Times, 3/14).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.