April 4, 2019
“Risk management is a critical function of the work that we do at the FDA to ensure the benefits of FDA-approved drugs and products outweigh the risks. One of the tools that we use in making sure that drugs have an appropriate benefit-risk balance is a Risk Evaluation and Mitigation Strategy (REMS). This is a drug safety program that the FDA can require for certain medications with serious safety concerns. If we determine a REMS is needed, most will include a requirement to foster communication between a doctor and patient, for example, about the specific safety risk or risks that the REMS is intended to mitigate. We may also require elements to assure safe use (ETASU) as part of a REMS, if the drug has been shown to be effective but is associated with a specific serious risk and can be approved only if, or would be withdrawn unless, certain elements are required as part of a strategy to mitigate a specific risk. These elements may, for example, help ensure providers have, or provide to patients, all the appropriate information to appropriately prescribe or dispense the medication. Today, we issued final guidance to clarify how the FDA applies six factors that impact the agency’s decision-making process regarding whether a REMS is required for a particular drug and what type of REMS might be necessary,” said FDA Commissioner Scott Gottlieb, M.D. “While REMS are a critical tool designed to reinforce medication use behaviors and actions that support the safe use of that medication, some companies also try to game the system and use REMS to delay the entry of generics. When a generic drug applicant wants to market a generic version of a drug that has a REMS with ETASU – the brand and generic drug makers are required to develop a single, shared REMS program unless the FDA waives that requirement and permits the generic drug to use a different, comparable aspect of the ETASU. We recently posted a manual of policies and procedures (MAPP) regarding the development of a single, shared system REMS for a brand product and its generic equivalents to clarify how this process unfolds here at the FDA. In some cases, branded sponsors have refused to sell samples of brand products with REMS with ETASU impacting distribution of the drug to potential generic competitors. Generic drug developers need the samples of the brand drug to develop their generic product and to conduct testing to show that their product is bioequivalent to the brand drug for FDA approval. The FDA cannot stand idly by and allow companies to abuse the system, frustrating generic drug manufacturers and ultimately keeping patients from accessing lower cost generic drugs. In May 2018, we first made available a list of companies that have potentially been blocking access to the samples of their branded products. Since then, we’ve updated this list once and will continue to do so to help deter companies from using REMS as an excuse.”
Today, the U.S. Food and Drug Administration issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary. This guidance clarifies how FDA determines whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks. It finalizes the draft guidance, issued on September 21, 2016.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.