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FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access

For Immediate Release:
Statement From:

To manage the risks associated with drugs, the FDA employs a range of tools. For drugs that are associated with serious risks, the FDA can require drug makers to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. REMS can contain a variety of tools – such as a Medication Guide or patient package insert with information specifically written for patients, a communication plan, and various “Elements to Ensure Safe Use” (ETASU). These elements may include requirements for prescriber training or patient counseling. These safety strategies are critical tools for the FDA to protect patient safety, which is why we want to help manufacturers apply these programs correctly, consistently, and efficiently.

But as I announced earlier this year as part of our Drug Competition Action Plan, we also need to make sure that REMS programs maintain their role in serving public health and don’t become a tool companies can use to delay or block competition from generic products entering the market. Today, we’re announcing that we are exploring a two-pronged approach to addressing shared REMS issues. First, we will continue to work to find ways to encourage the use of shared system REMS between all innovator and generic companies producing a drug. Second, we will explore new steps that the FDA can take to reduce the likelihood that branded drug companies can use the existence of REMS as a way to slow the entry of generic competition.

Current law requires that branded and generic companies try to reach agreement on the implementation of a single, shared system REMS rather than maintaining separate REMS for the branded drug and its generic competitor. Any generic drug application referencing a branded drug with a REMS with ETASU must use a single, shared system REMS with the innovator, unless the FDA waives that requirement and permits the generic drug to use a separate, comparable REMS program. But we know that negotiations to reach agreement on shared system REMS can take extended periods of time. This can block the timely entry of a generic competitor. I believe branded firms sometimes use these negotiations strategically, as a way to slow generic competitors.

To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA that represent all participating firms. Currently, under a shared system REMS, multiple applicants need to coordinate the submission of identical REMS-related documents for their respective applications. This draft guidance explains the FDA’s current thinking that 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.

The new process announced today will eliminate the need for each involved manufacturer to submit files individually. It eliminates duplicative paperwork for sponsors, and will decrease the volume of forms the FDA’s reviewers must assess. While submitting shared system REMS files this way is not a requirement, given the efficiency gains to both sponsors and the agency, we strongly encourage applicants to use the DMF for shared system REMS submissions.

As we work to make it easier to engage in a shared system REMS, we’ll be looking more specifically at how we can address situations where innovator firms may be leveraging the single, shared system REMS requirement to block or delay generic competition. As discussed, the requirement that the brand and generic sponsor use a single shared system to implement REMS with ETASU necessitates discussion and negotiation between two potential competitors. Because of the impact of generic entry on a brand company’s market share, brand companies often have an incentive to prolong these negotiations or refuse to agree to a single, shared system REMS. In addition to delaying generic drug approval, these negotiations are time- and resource- intensive for both industry and the FDA. This 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.

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.

Finding ways to facilitate more efficient agreement around shared systems REMS is an important public health goal. REMS are a vital tool for ensuring the safe use of certain drugs that have unique risks associated with their prescribing. Implementing REMS programs requires a coordinated effort and oversight across the health care system. Over the years, we’ve heard from stakeholders – including health care professionals, drug companies and other experts in health system management – urging the FDA to explore ways to improve efficiency and reduce the burden from REMS requirements. We’ve been steadily working to standardize these programs and better integrate them into the existing health care system. For example, through the REMS Integration Initiative, we recently developed a new, draft format for the REMS document that uses standardized language and section headers. This new format is expected to make the design, review, and implementation of REMS programs more straightforward and efficient.

My hope is that the use of a standardized process for collecting information in the new REMS document template will help streamline the drafting and review of shared system REMS making it easier for companies to engage in a shared REMS. It will also make it easier for us to implement additional reforms going forward that will result in more efficient resolution of negotiations over shared system REMS. Today’s action is a foundational step toward reforms we may implement in the near future. We’re continuing to make sure that our processes associated with REMS are clear and efficient and welcome comments to the docket on today’s draft guidance.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

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Sandy Walsh

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