3 Early ‘Cures Act’ Priorities for Gottlieb
Attorneys Bradley Davidsen and Elena Quattrone (Epstein Becker Green) say that now that Scott Gottlieb has been confirmed by the Senate as FDA commissioner, he faces three immediate priorities on mandates stemming from approval of the 21st Century Cures Act. Writing in an online blog post, the attorneys say that the act contains over 200 sections that create new obligations for FDA. Most pressing for Gottlieb, they say, are three requirements that must be fulfilled within 180 days of the act’s 6/11 passage:
- submission of a work plan to House and Senate committees for any projects that will use funding from the FDA Innovation Account created by the legislation;
- development of a plan to issue draft and final versions of one or more guidance documents over five years on the collection of patient experience data and the use of such data and related information in drug development; and
- publication of a list of reusable device types.
The writers note that Gottlieb has extensive experience with the drug industry and as an FDA deputy commissioner and so “will likely meet these deadlines based on his prior knowledge and experience.”