Risk Management Plan

Risk Management Plan

Developing, Implementing and Assessing a Risk Management Plan to Support Appropriate Use of a Schedule II Controlled Substance

Background

Risk management provides sponsors with a mechanism to support appropriate use of their products and ensure the benefits of the drug continue to outweigh the risks.  The most appropriate risk management strategy promotes use of the product consistent with the indication, while minimizing risk.  The Food and Drug Administration (FDA) has the authority to mandate risk management, including post-marketing surveillance.

Controlled substances pose unique risk management challenges because the nonmedical use (both misuse and abuse) may occur in patients and non-patients.  PinneyAssociates has more than 15 years experience developing, implementing and assessing risk management programs.

Situation

A medium-sized pharmaceutical company preparing a New Drug Application (NDA) for a Schedule II controlled substance in an existing drug class identified nonmedical use and diversion as potential risks for their product.  The client asked Pinney Associates to develop a risk management plan that would support appropriate use, satisfy regulatory expectations, and be adaptable to new products in the company pipeline.

Our Approach

PinneyAssociates developed a risk management plan that reflected the known benefits and risks of the product.  Our pharmacology and risk management experts assessed the product’s characteristics, including clinical benefits, tamperability and abuse potential, within the context of the epidemiology of nonmedical use of drugs.

Results

The FDA approved the final risk management plan submitted as a module of the NDA, including use of product packaging to reinforce appropriate use, patient and prescriber educational materials, and comprehensive surveillance based on both qualitative and quantitative data sources.

PinneyAssociates supports implementation of components of the plan, including data collection, analysis and interpretation.  Our reports have been submitted to FDA to satisfy reporting requirements. The risk management data have also been submitted to other regulatory agencies, used for internal decision making, and presented at scientific conferences on behalf of the sponsor.