• Susan C Nicholson, Janet Peterson, and Behin Yektashenas.
• Janssen Pharmaceuticals Scientific Affairs, LLC, Titusville, NJ, USA.
• Drug Saf. 2012 Feb 1; 35 (2): 91-104.

AbstractThe 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.

21 keywords...

hide…