New Panel Rules FDA Should Have Approved Gel
In a "big upset" for the FDA, a new panel of "independent scientific advisers" yesterday ruled that the agency should have approved a gel that helps reduce internal scarring from pelvic surgery, the AP/Richmond Times-Dispatch reports. The panel, meeting for the first time, said that Intragel, produced by Lifecore Biomedical, Inc., "does offer a benefit" in reducing adhesions caused during certain types of gynecologic surgery, and recommended that the FDA approve the product. The agency last year rejected Intragel, which is sold in Europe, on the advice of its medical device advisers, who said that it did not "properly prove effectiveness" and cited a study finding that the gel put its users at twice the risk of infection as other patients. The "novel" panel was convened by Dr. David Feigal, head of the FDA's Center for Devices and Radiological Health, in response to an "orde[r]" by Congress "to come up with [new] ways to resolve disputes" between drug and device makers and the FDA. The panel's ruling "could be precedent-setting," the AP/Times-Dispatch reports. Feigal now must decide whether to accept the panel's recommendation that Intragel be approved for sale. He declined comment on the subject yesterday (AP/Richmond Times-Dispatch, 9/7).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.