REMS Update: Risk Evaluation and Mitigation Strategies - what do you need to do now?

Why Should You Attend:

Risk Evaluation and Mitigation Strategy (REMS) continues to be a critical part of the FDA’s focussed efforts to increase safety of marketed products (drug or biological). As such they are enforceable by civil monetary penalties of up to $250,000 per violation that can continue to double for subsequent 30-day periods, up to $1 million per period, $10 million per proceeding. Products in violation of REMS requirements may not (continue to) be introduced into interstate commerce.

Proper adherence to REMS regulations is critical. However, the implementation of a REMS can be challenging. It must be undertaken by a specified protocol, departure from which requires agreement with the FDA. This webinar will explain the above. Participants will understand when a REMS will be required, the elements that need to be included in the REMs needed for their product, as well as details of the two-part format required for submission: the proposed REMS and the more detailed REMS supporting documents. Also, the FDA requirements and procedures continue to evolve. We will adress the agency's current thinking in some instances and show how they reduce the REMS obligations for sponsors.

Learning Objectives:

• When are REMS required?
• What elements need to be included in the REMS?
• What format should be used for submissions?
• How far have some of these requirements been relaxed?

Areas Covered in the Seminar:

• What content must you provide in a proposed Risk Evaluation and Mitigation Strategy (REMS) and what is the format required for a submission?
• What should you include in proposed modifications of an approved REMS?
• What identifiers should you use on REMS documents?
• How should you communicate with FDA about a REMS?
• What do you need to do to update drug safety information?
• When do you need to distribute a Medication Guide?
• What are the key points that you need to know about The Medication Guide Regulations?
• When can you take advantage of Shared System REMS?
• What do you need to know about of the March 2012 Draft Guidance on Drug Safety Information?

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel in pharmaceutical manufacturing, drug, biologic and clinical research companies:

• Regulatory Affairs
• Compliance
• Clinical Research Administrators
• Study Sponsors
• Legal
• Senior Management (production, supply chain and operations)

Instructor Profile:

Orest Hurko, is a Senior Clinical Consultant for the Biologics Consulting Group, Inc. in Alexandria, Virginia, with previous experience in Pfizer, Wyeth, GlaxoSmithKline, and SmithKline Beecham. Before joining industry he was on the faculty of the Johns Hopkins University School of Medicine. Currently he is Honorary Professor of Medicine, Nursing and Dentistry at the University of Dundee and Faculty member of the Biologics Development and Registration Course for PERI (Pharmaceutical Education and Research Institute).

Topic Background:

The requirements for Risk Evaluation and Mitigation Strategy (REMS) filings continue to evolve. While failure to comply properly continues to have serious consequences, recent guidances have in some instances reduced the burden of compliance. The Food and Drug Administration Amendments Act of 2007 gave the agency the authority to require a REMS from manufacturers at the time of submission on an NDA, BLA, or ANDA, if it considers it necessary to ensure that the benefits of a drug or biological product outweigh its risks. In addition, new safety findings in a marketed product may trigger a request for a REMS that must be submitted within 120 days. This document must contain a mandatory Timetable for Submission of Assessment of the REMS and one or more over of several other elements: (1) Medication Guide or Patient Package Inset (PPI), (2) Communication Plan, (3) Elements to Assure Safe Use (ETASU), and/or (4) an Implementation Plan. Now, 4 years after the REMS provisions of FDAAA took effect on March 25, 2008, when, there are 114 active REMS, 67 of which consist only of a medication guide or a communication plan. Furthermore, 105 REMS have been released and are thus no longer active. Knowledge of these precedents is a useful guide to what is – or is not – necessary for compliance.

Failure to adhere to REMS policy can result in serious consequences for your company. REMS continue to be a critical part of the FDA’s increased efforts to increase safety of marketed products. As such they are enforceable by civil monetary penalties of up to $250,000 per violation that can continue to double for subsequent 30-day periods, up to $1 million per period, $10 million per proceeding. Products in violation of REMS requirements may not (continue to) be introduced into interstate commerce. Proper adherence to REMS regulations is critical. However, the implementation of a REMS can be challenging. It must be undertaken by a specified protocol, departure from which requires agreement with the FDA. For these reasons, it is important for sponsors to know when a REMS will be required, the elements that are likely to be elements of the REMs needed for their product, as well as details of the two-part format required for submission: the proposed REMS and the more detailed REMS supporting documents.

Recent modifications in REMS policies may reduce the burden of compliance. It is important to remember that the requirements and procedures continue to evolve. Concerns about REMS have been voiced by a number of constituents, most notably in a recent PDUFA Stakeholder Public Meeting. In response to these concerns, John Jenkins (CDER Director in the Office of New Drugs) committed the FDA in December 2011 to an exploration of strategies and initiation of projects to standardize REMS with the goal of reducing the burden on practitioners, patients, and others in the healthcare setting. Knowledge about the agency’s current thinking can in some instances reduce the REMS obligations for sponsors. The most recent of these changes involve the regulations for Medication Guides, which are elements of 96 of the 114 currently active REMS. The Guidance on Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) that was issued in November 2011 provides useful information on two major topics:

• When a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS), and
• The circumstances in which the FDA exercises enforcement discretion about the distribution of Medication Guides. In these defined settings, this can reduce the burden on sponsors, prescribers and dispensers.

This document and the more recent Draft Guidance entitled “Drug Safety Information – FDA’s Communication to the Public (Revision 1),” that was issued in March of 2012, also describes when sponsors may submit a prior approval supplement that proposes a modification to eliminate the REMS. As of March 2012, 105 REMS have been released by the FDA, further reducing the regulatory burden on some sponsors.

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