October 13, 2017
Authored and Edited by Jon T. Self, Ph.D.; Basil "Bill" J. Lewris
FDA has shared its current thinking on the format and content of Risk Evaluation & Mitigation Strategies (REMS) documents. For all the details, check out FDA’s Draft Guidance for Industry, ‘‘Format and Content of a REMS Document.’’
FDA sometimes determines that a given prescription drug should have additional safeguards that go beyond professional labeling to ensure the drug’s benefits outweigh any risks, and to mitigate specific serious risks that may be listed in the labeling of the drug. This can occur pre- or post-approval; and when it does, the maker of the drug must develop a so-called REMS plan for FDA approval if it wants to keep the drug on the market.
For example, if a prescription drug is found to carry a risk of severe birth defects, FDA may require the drug maker to prepare a REMS plan for that drug, e.g., that instructs physicians to require negative pregnancy tests before refilling prescriptions. Currently, FDA requires REMS documents on fewer than 80 prescription drugs, a complete list of which can be found at REMS@FDA.
REMS may include several types of documents |
|
Medication Guide |
non-technical language; usually found with ETASU |
Communication Plan |
focused education, e.g., letters to physicians |
Elements to Assure Safe Use |
ETASU, e.g., special training/certification |
Implementation System |
e.g., drug maker’s plan to monitor ETASU adherence |
FDA’s 2017 REMS guidance lays out a new approach for REMS organization that draws on extensive feedback provided by stakeholders--such as pharmacists and prescribers--regarding the guidance of 2009. In particular, FDA has focused on making its 2017 REMS guidance clearer, more informative, and more standardized. FDA does not expect applicants of approved products subject to REMS to submit a proposed REMS modification solely to convert their REMS to the new format. Rather, changing to the new format should be part of other modifications to the REMS.
Organization sets 2017 REMS guidance apart from 2009 version |
|
2009 guidance organized by |
STATUTORY ELEMENTS |
2017 guidance organized |
WHO is tasked w/implementing requirement(s) |
WHEN requirement(s) to be implemented |
|
WHAT required action(s) is |
|
WHICH document type(s) required |
As noted in the 2017 guidance, FDA has made a template available for public use, which reflects the points raised in its nonbinding recommendations. The template is organized to identify the REMS Goals (describes the overall safety related outcomes that the REMS is designed to achieve); REMS Requirements (identifies the stakeholders, and their roles in implementing the REMS); REMS Assessment Timetable (a timetable for submission of assessments of the REMS); and REMS Materials (list of all materials that are required for the REMS). In a user-friendly manner, this handy template liberally uses tables and bulleted lists to more clearly present information, as well as employing the following color coding to enable all relevant information to be clearly presented in a single document:
KEY TAKEAWAYS
FDA welcomes public comment on its guidance documents, both during drafting and after release of final versions. For details on how to submit comments, see 82 FR 47529 (October 12, 2017); the comment period for this draft guidance ends December 11, 2017.
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