Some Biotech Industry Executives Raise Concerns About FDA Reorganization
A decision by the FDA to transfer oversight of biotechnology treatments to the same division that oversees traditional medications could "lead to an exodus of top regulators from the agency," raising concerns among some biotech industry executives, the New York Times reports. Under the reorganization, the FDA will transfer oversight of protein and antibody treatments from the Center for Biologics Evaluation and Research to the Center for Drug Evaluation and Research. The biotech industry "initially welcomed" the reorganization, which may reduce review times for new biotech treatments, but some executives have raised concerns that the reorganization could prompt a number of FDA officials with expertise in biologic treatments to leave the agency. Kathryn Zoon, director of the Center for Biologics Evaluation and Research, on Friday announced plans to leave the FDA for the National Cancer Institute, in part because of the reorganization. Jay Siegel, director of the Office of Therapeutics Research and Review, which oversees protein treatments, also said that the reorganization contributed to his decision to retire. William Rastetter, CEO of biotech company Idec Pharmaceuticals, said, "My concern is that they not lose the people with biologics expertise." Ira Loss of Washington Analysis, a research company that specializes in regulatory affairs, added that the reorganization "could eventually hurt the industry by undermining the argument that biologic drugs are so complex that generic versions should not be allowed," the Times reports (Pollack, New York Times, 12/16).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.