Financier Worldwide published an editorial by FLH Partner Brian J. Malkin on shared REMS in its October 2013 edition entitled, "Will the FDA provide more guidance or manage the process to share risk evaluation and mitigation strategies (REMS)?". Prior to FDA's response to the Prometheus Citizen Petition reported in our blog here, Mr. Malkin discussed his opinion whether FDA would undertake a more proactive process to manage shared risk evaluation and mitigation strategies ("REMS"). Mr. Malkin's analysis includes an overview discussion of the issue, namely negotiating the process whereby innovator and generic companies can work together to implement a shared REMS program. In the past, such negotiations have been particularly problematic when elements of the REMS were protected by patents or the negotiating parties were involved in a Hatch-Waxman litigation scenario.
In various citizen petitions and at FDA's Public Meeting Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) on July 25-26, it has been suggested that FDA take a more proactive role to bring innovator and generic companies together to form a new shared REMS. The shared REMS would provide a platform for all parties to work toward a common goal for effective patient risk management. In addition, FDA could take a more proactive role as part of its REMS standardization process to provide more open information concerning REMS assessments for the industry to better understand what REMS elements work best. Presently, FDA has provided little guidance how the parties are expected to negotiate a shared REMS when there are outstanding issues of compensation, liability, and control under the backdrop of patents or proprietary information.
FDA Lawyers Blog and FLH would like to make sure that you have a chance to read Mr. Malkin's editorial, so we are providing a copy for download here. We hope that this helps to stimulate some additional thought and discussion about the topic.