AAM, PhRMA Renew Rivalry In Hatch-Waxman Public Comments

22 Nov 2017

• By Michael Cipriano

Generic association advocates enforcement action against companies that use REMS to block generics while PhRMA disputes claims of REMS abuse and citizen petition delay tactics.

In what has been a busy year of innovators and generic companies sparring over how to foster a more competitive marketplace, the Association for Accessible Medicines (AAM) and the Pharmaceutical Research and Manufacturers of America (PhRMA) renewed their rivalry on the issue in comments to the US FDA.

The groups submitted recommendations to an FDA docket opened in connection with the agency's July public meeting on administering the...