Keeping Track: Approval Elusive For Biosimilar Neulasta; Valeant Gets A Nod And A No From FDA; Submissions From Amgen, Puma, Bristol

FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting the agency in unprecedented ways about three weeks into his tenure.

Manufacturers have supported the proposed shift in oversight authority, which could create a more pharma-friendly environment in the drug discount program, but uncertainty remains.

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.