USA – FDA revises REMS MAPP for new comparable ETASU provisions

The US Food and Drug Administration (FDA) this week revised its manual of policies and procedures (MAPP) to reflect recent statutory changes that make it easier for drugmakers to develop separate risk evaluation and mitigation strategies (REMS) with comparable elements to assure safe use (ETASU).

The Further Consolidated Appropriations Act, 2020, which was enacted late last year, included two provisions aimed at increasing generic and biosimilar competition.

Specifically, the act provides generic and biosimilar developers with a path to file civil actions against reference drugmakers that do not provide access to sufficient quantities of samples needed to conduct testing and makes it easier for companies to establish separate REMS programs with comparable ETASU. The act also expanded FDA’s ability to require REMS modifications to accommodate different, comparable ETASUs…