FDA NEGOTIATION STRATEGIES

The FDA can require a Risk Evaluation and Mitigation Strategy (REMS) for prescription drugs and biologics if the agency determines it is necessary to ensure that the benefits of the medication outweigh the risks. REMS are designed to reduce or eliminate the risks associated with these medications by implementing a variety of risk minimization strategies.

When the FDA requires a REMS for a drug, the sponsor of the drug product must negotiate with the FDA to develop the requirements for the REMS. This process can be complex and time-consuming, and it is important for sponsors to have a strong understanding of the REMS requirements and the FDA’s negotiating process.

The REMS Negotiation Process

The REMS negotiation process typically begins with the FDA providing the sponsor with access to the REMS guidance document. This document outlines the FDA’s requirements for the REMS, including the specific risk mitigation strategies that must be implemented.

The sponsor then has the opportunity to review the draft guidance document and provide feedback to the FDA. Once the FDA has considered the sponsor’s feedback, the two parties will begin negotiations to finalize the REMS.

The REMS negotiation process can be complex and time-consuming. It is important for sponsors to be prepared to provide detailed information about the drug and its risks, as well as the risk mitigation strategies that they propose to implement.

Understanding the landscape for designing and negotiating a REMS is the first step to any successful outcome, be prepared with expert support. ADROIT has more than a decade of experience negotiating successful REMS with FDA.

If you need help navigating REMS negotiations, let your first choice be your best, chose ADROIT Risk Management as your partner.