REMS: BIO Comments on Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document
December 11th, 2017
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA-2009-D-0461: Format and Content of a Risk Evaluation and Mitigation Strategy Document
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
BIO commends FDA on this Draft Guidance which provides recommendations to applicants on drafting proposed Risk Evaluation and Mitigation Strategy (REMS) documents and converting an already-approved REMS document to a new standardized format.
- The Draft Guidance should include additional REMS Requirements for REMS programs run or administered through specialty pharmacy healthcare settings. Requirements should include enhanced/expanded communication with prescribers and/or patients, which is within the workflow for specialty pharmacies.
- The Draft Guidance should specify the following:
- Who is responsible for storage and retention of certain REMS participant documents (e.g., completed forms)
- Who is responsible for monitoring of patients (see lines 67 and 70) subject to REMS (see also lines 197 and 480, as well as parts of HCP and dispensing sections). On this issue, it is not clear from the guidance whether it is the HCP and/or pharmacy. Also, it is not clear whether line 197 refers to HCP/dispensing participants, and not patient participants. Clarification is requested.
- The duration of retention of these participant materials
BIO appreciates this opportunity to submit comments on the Draft Guidance on Format and Content of a REMS Document. We provide additional specific, detailed comments to improve the clarity of the Draft Guidance in the following chart. We would be pleased to provide further input or clarification of our comments, as needed.