title: Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.
abstract: OBJECTIVE
  1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products.
  
  
  METHODS
  FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs.
  
  
  RESULTS
  We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%).
  
  
  CONCLUSIONS
  Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively.
authors.affiliation: PAREXEL International, Uxbridge, UK.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Lis
authors.forename: Melissa H
authors.initials: MH
authors.lastname: Roberts
authors.forename: Shital
authors.initials: S
authors.lastname: Kamble
authors.forename: Jeff
authors.initials: J
authors.lastname: J Guo
authors.forename: Dennis W
authors.initials: DW
authors.lastname: Raisch
mesh_terms: D017277:Drug Approval / Q000458:organization & administration* / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced*; D017850:Economics, Pharmaceutical; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018570:Risk Assessment; D012308:Risk Management / Q000458:organization & administration* / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration* / Q000706:statistics & numerical data