ARTICLE | Regulation

Europe speeds away

EC's fast track plan, FDA hurdles, could drive antibiotics developers to Europe

December 19, 2011 8:00 AM UTC

The European Commission's new action plan to combat antimicrobial resistance could further widen the regulatory gap between the U.S. and Europe, which is already at the point where some physicians worry companies will no longer seek FDA approval of their antibiotics.

Indeed, the U.S. agency's insistence on what companies and clinicians say are clinically irrelevant endpoints has already resulted in one drug being approved in Europe this year but not in the U.S. And FDA's requirements for what companies and doctors say are unfeasible clinical trial designs have already lead some companies to wait for the agency to change its tune before performing Phase III studies for U.S. approval...