November 8, 2017
Authored and Edited by Christina Ji-Hye Yang; Susan Y. Tull
On November 8, 2017, FDA released nonbinding draft guidance on “Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy (REMS) Submissions.” FDA intends to improve the efficiency of shared system REMS (SSR) submissions to FDA. The guidance is one of FDA’s two-pronged approaches to address SSR issues, specifically to reduce branded drug companies’ use of REMS programs as a tool to delay or block competition from generic products entering the market. FDA intends to achieve this goal by allowing manufacturers with products in SSR programs to submit one collective set of files to FDA.
The guidance notes several circumstances in which SSR may be used. For example, FDA may require REMS to include one or more elements to assure safe use for an innovator drug, in which case any ANDA referencing that innovator drug must use an SSR with the innovator unless it has been waived. Also, multiple applicants may form an SSR to minimize the burden on the health care delivery system, such as for a class of similar products. In these cases, FDA recommends multiple applicants use a Type V Drug Master File (DMF) for their SSR submissions to improve the efficiency of the submission and review processes.
In the next section, the guidance provides recommended steps for preparing the SSR DMF. The guidance notes that the owner of the SSR DMF is the DMF holder—one company jointly designated by the SSR applicants. FDA will contact the DMF holder regarding technical issues and questions about the administrative content of the DMF. When the DMF holder submits to the SSR DMF, it is binding on all participating SSR applicants. The DMF holder is required to submit letters of authorization to the DMF, which permit FDA to review information in the DMF in support of the SSR applicants’ applications. In doing so, the DMF holder must submit a separate letter of authorization to the DMF for each SSR applicant, even if the SSR applicant is also the DMF holder. A new letter of authorization is not required for each new submission, unless there is a change in the DMF holder name or the authorized party name.
The guidance lists recommended contents of the SSR DMF, which include only the information related to the SSR. Application-specific information should be submitted by an applicant to its own individual application. Examples of the recommended items include the REMS document, the REMS materials, the REMS supporting document, REMS assessment methodologies and REMS assessments, REMS correspondence, REMS history, any interim versions of documents that need FDA’s review, any responses to FDA requests for information concerning the SSR, documents that are submitted to all DMFs, such as the DMF amendments and letters of authorization. In addition, the guidance lists items that should not be submitted to the SSR DMF, but should be submitted to each applicant’s individual application, such as labeling including Medication guides, product-specific information including REMS assessment adverse event summaries, REMS changes that apply to only one application in the SSR.
The guidance also provides a list of cross-reference submissions that an SSR applicant should include in its individual application, to incorporate by reference information that the DMF holder has submitted to the SSR DMF. These submissions include REMS original, minor REMS modification, major REMS modification, REMS modification due to safety label changes, REMS revision, and REMS assessment. On the other hand, the guidance notes that a cross-reference submission is not required for REMS assessment methodology, REMS correspondence, interim versions of REMS documents, REMS materials, or REMS supporting documents, and responses to FDA requests for information.
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