Gottlieb's FDA

FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition.

Neither the brand nor the generic drug lobby appear keen on FDA Commissioner Scott Gottlieb’s idea to publish the letters it sends to brand companies explaining that a potential generic competitor has adequate safety protections in place to be sold brand drug samples for the bioequivalence testing required as a prerequisite of generic approval.

FDA on Thursday (Dec. 7) took steps to fulfill the digital health provisions in the 21st Century Cures Act by issuing a suite of guidances that reveal which clinical decision support (CDS) tools won't be considered devices.

FDA published final guidance Monday (Dec. 4) aimed at helping CMS determine which investigational devices to cover by streamlining the categorization of investigational device exemption (IDE) products -- completing a process launched in 2015 through a Memorandum of Understanding (MOU) between FDA's device center and CMS' Coverage and Analysis group (CAG).

FDA's biologics center will encourage flexible clinical trial designs for regenerative medicine by considering trials that incorporate adaptive designs, enrichment strategies or novel endpoints.

FDA on Thursday (Nov. 30) approved the first once-monthly buprenorphine injection -- a drug-device combination product -- to be used to treat moderate-to-severe opioid use disorder (OUD).

FDA is forming a Nicotine Steering Committee composed of agency leaders tasked with revamping FDA's policies surrounding nicotine replacement therapy (NRT) products, FDA Commissioner Scott Gottlieb, drug center chief Janet Woodcock and Center for Tobacco Products Director Mitch Zeller wrote in a Wednesday (Nov. 29) FDA Voice blog.

FDA is developing a policy by which the agency can approve subsequent indications of cancer drugs with less rigorous follow-up trials, FDA Commissioner Scott Gottlieb announced Thursday (Nov. 30).