FDA revises REMS MAPP for new comparable ETASU provisions

Regulatory NewsRegulatory News | 30 October 2020 |  By 

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.
According to the new MAPP, abbreviated new drug applications (ANDAs) “may use a [single, shared system] SSS with the listed drug or a different, comparable aspect of the ETASU.”
Previously, drugmakers were required to use an SSS with the reference listed drug (RLD) for any ETASU, unless FDA specifically waived the requirement. Such waivers were only permitted if FDA determined that creating the SSS was too burdensome or if an unexpired patent or trade secret protecting the ETASU prevented the ANDA applicant from joining a shared REMS.
However, while ANDA applicants no longer have to obtain a waiver to use a separate REMS, FDA may still require the use of a SSS with the RLD “if it determines that no separate REMS could satisfy the necessary requirements.”
FDA’s newly revised MAPP reflects those changes and removes reference to the waiver provisions that were included in the original document. The agency still says it will encourage ANDA applicant(s) and RLD new drug application (NDA) holder to form an industry working group to develop a SSS.
The MAPP also explains how the agency will handle notifications to RLD NDA holders concerning modifications to a REMS to accommodate a separate REMS.


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