US FDA's Gottlieb Touts 'Seamless' Clinical Trials, Worries About Second-To-Market Products

Commissioner tells House hearing that agency study found troubling drop in innovative competition; clinical trial reform, including encouraging surrogate markers, could speed development of products that may create pricing pressure on brands.

As the US FDA continues its implementation of the 21st Century Cures Act, the agency will be releasing guidance "very soon" on how sponsors can conduct "seamless" trials as part of the law's broader effort to modernize clinical studies, Commissioner Scott Gottlieb announced.

Testifying July 25 before the House Energy and Commerce Subcommittee on Health on the implementation of the Cures Act, Gottlieb explained that the one of the things the guidance will do is explain how drugmakers

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