The primary objective of REMS is to enhance drug safety by ensuring that the benefits of a drug outweigh its risksOn September 27, 2007, the Food and Drug Administration Act of 2007 (FDAAA) was signed into law. FDAAA 2007 included several key provisions, and gave the authority for FDA to require a Risk Evaluation Mitigation Strategy (REMS) from drug manufacturers. The primary objective of REMS is to enhance drug safety by ensuring that the benefits of a drug outweigh its risks. FDAAA 2007 became effective on March 25,2008. REMS differ from previous risk management approaches (e.g., Risk MAPS) in several significant regards: they are well defined and legally enforceable.REMS can range from a simple Medication Guide and Assessments of REMS implementation and effectiveness to plans that include Communication plans with healthcare providers and complex distribution restrictions Elements to Assure Safe Use (ETASU). Of the various components of REMS, ETASU represents the greatest challenge for all involved stakeholders. ETASU can include restrictions on various stakeholders (e.g., provider, physician, patient), and are ultimately distribution restrictions. Entereg was the first new product for which the FDA required this restrictive element (May 2008), although a number of drugs with RiskMAPS approved prior to 2008 were deemed to have met the requirements for REMS including ETASU (e.g., Accutane, Tysabri). Since then, the agency has required ETASU for >20 products: 4 in 2008, 5 in 2009 and 12 in 2010.Our latest REMS report reviews 157 REMS for NDAs and BLAs implemented from March 2008 –when the FDA approved 16 drugs with existing RiskMAPS as meeting the requirements for REMS– until the end of 2010. We analyze the yearly percentage of new molecular entity (NME), new drug application (NDA) and biologics license application (BLA) requiring REMS from 2008-2010.We forecast six future key trends in REMS requirements based on data in the last 3 years and interviews with industry experts. Finally, given that REMS are likely to impact a significant number of drugs, we review the key implications for Biopharma, including drug approval rates and timelines, cost of commercialization and drug utilization/uptake.

Authors: Stephane Budel, Partner at DeciBio, LLCConnect with Stephane Budel on Google+https://plus.google.com/+StephaneBudel