Animal Rule Studies Should Be As Well-Designed As Human Clinical Trials, Panel Says
FDA's Anti-Infective Drugs Advisory Committee unanimously said ciprofloxacin and Ortho-McNeil-Janssen Pharmaceuticals Inc.’s Levaquin (levofloxacin) had proven their efficacy for pneumonic plague in studies in African Green Monkeys, but the panel may be less willing to overlook study design flaws in less life-threatening conditions.
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FDA’s Anti-Infective Drugs Advisory Committee will have new pharmacokinetic data to review when it meets Nov. 2 to discuss the monoclonal antibody, which targets the anthrax toxin rather than the pathogen.
Sidney Wolfe’s stint as permanent member of the Drug Safety and Risk Management Advisory Committee ended May 31; his final meeting was the May 23 review of Xarelto for ACS. That gave him a second chance to vote against the product. A look back at Wolfe’s tenure shows he was a sure “no” vote when he sat on a panel—but that his service can hardly be construed as having damaged the industry.
Study requirement for J&J’s antibiotic is less onerous than the studies that were imposed for the two other products approved under the Animal Rule.