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Risk Evaluation and Mitigation Strategies (REMS)

Educating the Prescriber

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The US FDA Amendments Act of 2007 was signed into law on 27 September 2007. A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (REMS). REMS are deemed necessary when a question exists as to whether the benefits of a drug outweigh its risks. REMS constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients. This applies to existing drugs on the market, new drug applications (NDAs), abbreviated NDAs (generics) and biologics licence applications. REMS represent an ‘upgrade’ from previously required risk minimization action plans, based on the strengthening of FDA powers of authority and enforceability to incur monetary penalties against individuals representing the pharmaceutical industry who fail to comply.

For illustrative purposes, we chose the drug romiplostim (Nplate®) to present an REMS, as all components were utilized to help assuage risks associated with the drug. Romiplostim is an FDA-approved drug used to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura that has a significant adverse safety profile based on the risk of changes in bone marrow reticulin formation and bone marrow fibroses, and other associated risks.

This review of current REMS policy is intended to provide the prescriber with a better understanding of current modalities in FDA-mandated drug safety programmes, which will impact day-to-day healthcare provider practices.

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Acknowledgements

Susan C. Nicholson, MD, is an employee of Janssen Pharmaceuticals Scientific Affairs, LLC, Titusville, NJ, USA; Janet Peterson, PhD, and Behin Yektashenas, PharmD, are employees of Janssen Scientific Affairs, LLC, Raritan, NJ, USA.

The authors would like to acknowledge medical writing support for the preparation of this article provided by Ira Mills, PhD, and Craig Ornstein, PhD, both of Embryon, Somerville, NJ, USA. This assistance was funded by Janssen Pharmaceuticals Scientific Affairs, LLC, Titusville, NJ, USA, and Janssen Scientific Affairs, LLC, Raritan, NJ, USA.

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  1. Pharmacovigilance Strategy Leader, Janssen Pharmaceuticals Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Mailstop #33A, Titusville, NJ, 08560, USA

    Susan C. Nicholson

  2. Janssen Scientific Affairs, LLC, Raritan, NJ, USA

    Janet Peterson & Behin Yektashenas

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  1. Susan C. Nicholson
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Correspondence to Susan C. Nicholson.

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Nicholson, S.C., Peterson, J. & Yektashenas, B. Risk Evaluation and Mitigation Strategies (REMS). Drug Saf 35, 91–104 (2012). https://doi.org/10.2165/11597840-000000000-00000

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