Essential Changes to Shared REMS

Comment to Proposed FDA Regulations, 2018

1 Pages Posted: 1 Aug 2018

Date Written: July 12, 2018


This short comment applauds the FDA's proposed Guidances on shared REMS (Risk Evaluation and Mitigation Strategies). The FDA requires REMS when a drug’s risks (such as death or injury) outweigh its rewards. Brands have used REMS, intended to bring drugs to the market, to block generic competition. While most of the attention has taken place on the “front end” when a brand denies a needed sample, there can also be abuse on the “back end” when brands slow-walk negotiations with generics to create shared REMS. Because there may not be a discrete refusal, the conduct presents nuanced issues. This comment applauds the FDA’s proposed changes to the “waiver” process, which allow the agency to more quickly approve generic REMS. It explains how the timing and substance of the changes make sense and restore the statutory objectives. In ensuring that the perfect (unattainable shared REMS) is not the enemy of the good (earlier generic entry), the Guidances benefit the health care system and consumers.

Keywords: REMS, Drugs, Pharmaceuticals, Brands, Generics, FDA

JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38

Suggested Citation

Carrier, Michael A., Essential Changes to Shared REMS (July 12, 2018). Comment to Proposed FDA Regulations, 2018. Available at SSRN:

Michael A. Carrier (Contact Author)

Rutgers Law School ( email )

217 North Fifth Street
Camden, NJ 08102-1203
United States
856-225-6380 (Phone)
856-225-6516 (Fax)

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