Maine Law Attempts to Curb REMS Restrictions for Biosimilar Applicants

We have previously reported on the Risk Evaluation and Mitigation Strategy (REMS) program, its effect on generic development, and the FDA’s guidance on how to prevent brands from using the REMS program to block generic entry.  For an overview of REMS click here.

On July 4, 2018, the Maine legislature enacted 2017 ME S 432, titled “An Act To Require Drug Manufacturers To Comply with Federal Law.”  This law attempts to curb REMS restrictions for biosimilar applicants by requiring drug manufacturers or wholesalers licensed in Maine to make a drug distributed in the State available for sale to “an eligible product developer,” defined as “a person that seeks to develop an application for the approval of a drug under the Federal Food, Drug, and Cosmetic Act [FDC Act], Section 505(b) or 505(j) or the licensing of a biological product under the federal Public Health Service Act, Section 351.”  The law mandates that the drug be supplied “at a price no greater than the wholesale acquisition cost and without any restrictions that would block or delay the eligible product developer’s application in a manner inconsistent with Section 505-1(f)(8) of the Federal Food, Drug, and Cosmetic Act, 21 United States Code, Section 355-1(f)(8) (2016) [i.e., the provision prohibiting the use of REMS to block competition].”  The law also permits the State of Maine to seek injunctive relief against any person who violates these provisions.

Maine is the first state to pass a law that seeks to curb REMS abuse.

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