FDA acting commissioner Ostroff plans to hold course

Acting FDA Commissioner Stephen Ostroff told BioCentury he plans to keep FDA on the course set by his predecessor, Margaret Hamburg. Ostroff, who is starting his third week as acting commissioner, presented a detailed agenda for the agency to reporters Monday, focusing on food safety and regulation of tobacco products. He said it is "hard to imagine substantial new priorities, at least in the short-term" beyond those Hamburg set over the last six years.

Ostroff reiterated concerns Hamburg had expressed publicly that a discussion draft of the 21st Century Cures Act could divert FDA resources from medical product reviews and approvals, and that provisions in the draft could lower safety and efficacy standards. He reported that FDA staff have been advising the House Energy & Commerce Committee about provisions that would be better deferred for consideration in PDUFA reauthorization negotiations rather than legislated in the 21st Century Cures Act. ...