Pharmaceutical risk management


  • A comprehensive risk assessment of a centrally acting prescription product based on standard of care and real-world use
  • A risk management plan or Risk Evaluation and Mitigation Strategy (REMS)
  • Incorporation of relevant patient experience data into a structured benefit-risk assessment as required by the 21st Century Cures Act
  • An evaluation of the key elements that factor into the FDA’s Benefit-Risk Integrated Assessment for your prescription product.


  • Assess potential for misuse and/or off-label use, and relative risk for nonmedical use, misuse and abuse for CNS active drugs with abuse liability
  • Provide guidance on appropriate risk management steps for prescription and over-the-counter products
  • Provide guidance on the design of pre-approval studies to determine if a REMS is needed, and if so, to support a proposed REMS
  • Design surveys to assess behaviors/health indicators in the general population and target populations
  • Provide guidance on appropriate assessment strategies for REMS with Elements to Assure Safe Use (ETASU)
  • Advise and assist in discussions with FDA during development of a REMS
  • Develop comprehensive benefit-risk analyses for new chemical entities
  • Identification of critical benefit-risk elements that factor into a regulatory decision or recommendation for a prescription or over-the-counter product
  • Develop and assess risk management tools
  • Manage expert advisory boards on a range of topics, including abuse liability, product safety, and appropriate use
  • Support effective meetings with regulatory agencies—from preparation to direct participation by world-leading experts
  • Design and implementation of REMS and other post-marketing studies


  • Population Health Surveillance
  • Regulatory and Health Policy
  • Clinical and Behavioral Research
  • Data Management and Statistical Analysis
  • Integrated Strategic Communications

PinneyAssociates is a recognized leader and innovator in the design and implementation of pharmaceutical risk management programs. Our risk management experience spans the preclinical and clinical development program through post-marketing activities across a broad spectrum of CNS-active drugs and other products with abuse potential including those with restricted distribution, limitations on prescribers and dispensers, as well as all levels of controlled substances and all types of over-the-counter products, and hospital-based products.

Our experts regularly interact with and advise U.S. and international regulatory and independent organizations including: The Food and Drug Administration, Drug Enforcement Administration, National Institute on Drug Abuse, Substance Abuse and Mental Health Services Administration, Congress, World Health Organization, Food and Drug Law Institute.