Maine Passes Law to Address Misuse of REMS Programs

This month, the Maine legislature authorized a bill titled “An Act to Require Drug Manufacturers to Comply with Federal Law,” or 2017 ME S 432, which seeks to combat the misuse of Risk Evaluation and Mitigation Strategy (REMS) programs within the state.

The bill requires drug manufacturers licensed in Maine to make a drug distributed within the state available for sale to an “eligible product developer for purposes of conducting testing required to support an application for approval of a drug.”

It goes on to mandate that the drug be made available for sale at an appropriate price, “no greater than the wholesale acquisition cost and without any restriction that would block or delay the eligible product developer’s application.”

Maine is the first state to pass a law that addresses the misuse or misapplication of REMS programs within its jurisdiction.

Branded drug manufacturers have used REMS programs as a way to block or delay generic or biosimilar entry in the marketplace by impeding a developer’s ability to access samples of innovator products that are required for testing by those seeking to develop competitive products. Recently, FDA Commissioner Scott Gottlieb, MD, has spoken out about the abuse of the programs, and has issued new policies to try to address the issue.

“The REMS shouldn’t become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market…our aim is to help generic drug makers get their products through the development and approval processes efficiently while maintaining the safety controls sought by the REMS,” said Gottlieb in a recent statement.

In May, Gottlieb introduced 2 new draft guidance documents to address the misuse of REMS programs. The first guidance document, titled “Development of a Shared System REMS,” outlines the process and recommendations for developing a shared system REMS program, under which applicants share in the implementation and maintenance of any database and infrastructure for the program and share in carrying out assessments. The second document, “Waivers of the Single, Shared System REMS Requirement,” provides an overview of how the FDA will consider granting a waiver on a case-by-case basis of a shared system REMS program for reference products that include Elements to Assure Safe Use (ETASU).