Understanding Regulatory and Market Access Considerations With Drug Abuse Potential

Each assessment for abuse liability is as unique as the molecule in question, reiterating the importance of early awareness, understanding the current regulatory landscape, and being able to plan your development and post-marketing accordingly.

In our previous blog post, we focused on the value of early drug abuse potential testing. In this blog, we’ll delve into important regulatory and market access considerations for abuse liability testing that can help drug developers maximize the potential of their molecule.

Adapt to the latest regulatory changes
Despite all the current regulatory guidelines, acts and plans, there is no single strategy for success. The ongoing opioid epidemic and abuse of prescription drugs has triggered a more conservative regulatory environment on the evaluation of abuse liability overall.

In the United States, the FDA currently has three guidelines regarding drug abuse: the 2010 draft guidance on the assessment of abuse potential of drugs, the 2015 guidance on the evaluation and labeling of abuse-deterrent opioids, and the 2016 draft guidance on abuse-deterrent formulations of generic opioids.

Globally, the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (CHMP) has also adopted guidelines, as has Health Canada. The International Conference on Harmonization (ICH) also provides guidance supporting the design of both nonclinical and clinical evaluation of abuse potential.

Sponsors developing a new molecular entity that affects the central nervous system should understand the regulatory shifts, challenges and opportunities for accurately assessing the abuse liability potential of their drug.

Open a dialogue with regulatory agencies
The evolving guidances and requirements around abuse liability testing can be difficult to navigate, but help is available. This is especially important given the increased scrutiny and potential human cost: In 2014, almost 2 million Americans were dependent or abused prescription opioids¹.

The FDA has shown that it is willing to work closely with sponsors with the goal of developing more reliable nonclinical models and clinical study designs that facilitate the development of novel analgesics with lower potential of abuse. In addition, contract research organizations often help sponsors prepare for and guide these critical conversations with various regulatory agencies.

Incorporate market access perspectives
Beyond clinical efficacy and safety, stakeholders and payers need evidence that a product offers compelling value. While running a set of comprehensive abuse liability studies, it’s also wise to think about a market access / reimbursement strategy.

Depending on the results of the abuse liability testing, a product may require scheduling under the Controlled Substance Act of 1970, which will determine specific labeling, record keeping/dispensing limits and face distribution restrictions – all factors that may impact market access. The earlier a sponsor begins crafting its market value story and identifying the best connection between their product and the market, the better the chance for commercial success.

Our team of experts is known for creating comprehensive regulatory strategies for clients and contributing to policy discussion in the field. We actively participate in the Cross Company Abuse Liability Council and in the College on Problems of Drug Dependency (CPDD). Learn more about how our drug abuse liability expertise and solutions will help advance your molecule.

¹ Substance Abuse and Mental Health Services Administration, National Survey on Drug Use and Health, 2014.