Gottlieb Sends Message About REMS and Market Competition

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FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.

On Nov. 8, 2017, Scott Gottlieb, MD, commissioner of FDA, announced that the agency will be streamlining the submission and review process for shared systems Risk Evaluation and Mitigation Strategy (REMS). A draft guidance outlines how applicants can submit collective files to represent all participating firms. This new process will help the agency address the problem of companies leveraging the REMS requirement to block or delay the development of generic drugs.

Currently, each manufacturer involved in a shared systems REMS has to submit identical REMS-related files to FDA individually. The new process will eliminate duplicate paperwork and decrease the amount of forms FDA must review. “The use of a single Drug Master File (DMF) for shared system REMS submissions will allow manufacturers with products in shared system REMS programs to submit one collective set of files to the agency. This is a first step toward additional actions FDA plans to take to making sharing a single REMS easier,” Gottlieb said in a statement.

A REMS uses tools to assess the risk versus benefit of drug products. The single, shared system REMS requirement necessitates the discussion between two potential competitors. In the past, brand companies have prolonged these discussions or refused to agree to a single, shared system REMS to potentially delay generic competitors from entering the market. These delays also impact FDA, Gottlieb said.

“This [practice] is not in the best interest of public health. Not only is the approval of a generic competitor delayed, but also the drug approval process is less efficient,” Gottlieb stated. “We plan to provide more information about how and when the FDA intends to consider waiving the requirement that an innovator and generic utilize a shared system REMS. These new policy steps will include information on how and when generic drug applicants can request a waiver and the factors that the FDA intends to consider. A waiver would free generic entrants from the requirement that they reach agreement with a branded firm for a shared system REMS. This can obviate the ability of branded sponsors to use these negotiations as a way to slow generic entry. We believe that addressing this problem will allow for the more efficient approval of generic drugs while maintaining the safety controls sought by the REMS.”


This isn’t the first step the agency has taken to enhance the REMS system, which, according to Theresa Toigo, MBA, RPh, associate director for Drug Safety Operations, FDA Center for Drug Evaluation and Research, have raised concerns that REMS requirements could delay treatments reaching patients. FDA recently developed a new, draft format for the REMS document with standardized language and section headers and restructured the REMS@FDA website. REMS has been integrated into a Structured Product Labeling (SPL) format to make REMS information available within healthcare systems, and FDA published a report detailing best practices for healthcare professionals. The agency plans on developing more reforms in the future to ensure efficient processes.

The agency recently completed its REMS Integration Initiative, to standardize REMS programs and better integrate them into the healthcare system. FDA met with think-tanks and standards development organizations and held three public meetings, five workshops, and 15 listening sessions. A pilot project was launched with nine companies whose products require REMS programs. “FDA will continue to make every effort to ease the burden of REMS requirements. Our goal is to maintain patient access while still ensuring safe use of a drug,” Toigo stated in an FDAVoice blog post.

Source: FDA