FDA APPROVALS: Green Light Has Yellow Cast, Henney Warns
Americans should understand that the FDA's seal of approval does not imply the product is risk-free, FDA Commissioner Jane Henney told an assembly of biotech executives at the University of California-Berkeley's Haas School of Business yesterday. Even products that pass rigorous safety tests have "an element of risk," she said, noting that some could have unanticipated side effects or could be improperly used or prescribed. "When we say we do safety tests, we understand safety is a risk-benefit equation," she said. But when people hear "safety test," they have "translated that into 'safe,' meaning no risk, and that's not the concept we want to get across," she added. Addressing another area of concern, Henney assured the 200 industry representatives that her agency is working to speed the approval process for drug candidates in part "by beefing up its in-house scientific research." For example, she said, FDA researchers are making strides in studying the risks associated with xenotransplantation, the San Francisco Chronicle reports (Abate, 6/29).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.