Practice Areas

Sponsors are increasingly required to develop comprehensive risk management programs, including risk assessment and minimization, also known as Risk Evaluation Mitigation Strategies (REMS). Implementation of pharmaceutical risk management can impact labeling, regulatory decisions, legal protection, intellectual property, enforcement, marketing, and company reputation. The ultimate goal of risk management should be to maintain the benefits of the product while mitigating the risks.

Pinney Associates teams have the knowledge and resources to help clients find the most appropriate path to enhance product safety and marketability by assessing the scientific and policy environment, and evaluating individual compounds and formulations within the risk management context.  We work with clients to assess benefits and risks associated with both appropriate and inappropriate use. This forms the basis for a comprehensive risk management strategy that will address regulatory concerns, facilitate commercial goals, and protect the franchise long into the future.

Our risk management experience spans pre-launch, launch and post-launch activities for a broad spectrum of products with restrictions on distribution, providers, dispensers, controlled substances, over-the-counter products, and hospital-based products. Our experts are recognized leaders in pharmaceutical risk management who regularly interact with numerous 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, the Food and Drug Law Institute, the College on Problems of Drug Dependence, American Pain Society and the World Health Organization.

Our team:

• Develops comprehensive benefit-risk analyses
• Analyzes pharmacology within preclinical and clinical studies, misuse and/or off-label use, and relative risk for nonmedical use, misuse and abuse among specific population
• Designs and implements REMS (Risk Evaluation and Mitigation Strategies) and (RMP) risk management plan development, implementation and assessment
• Develops and assesses risk management tools
• Prepares documents and advises on regulatory submissions
• Supports preparations and attends meetings at regulatory agencies with sponsors
• Manages external expert advisory boards on a range of topics, including abuse liability, product safety, and appropriate use