FDA Guidance on Generic Abuse-Deterrent Opioid Medications

The U.S. Food and Drug Administration (FDA) recently released draft guidance that “recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug.” This guidance is part of the objective to “expand access to abuse-deterrent formulations (ADFs) to discourage abuse” within the FDA Opioids Action Plan “to take concrete steps toward reducing the impact of opioid abuse on American families and communities.” While ADFs do not make a drug product impossible to abuse or prevent addiction, overdose or death, ADFs “make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject its contents, more difficult or less rewarding.” Comments on the draft guidance are encouraged to be submitted by 24 May 2016, and the FDA will hold a public meeting later in 2016 to “discuss further the evaluation of the abuse deterrence of generic opioid drug products and related issues.” For additional information, see the 3/24/16 FDA news release, and the notice of availability published at 81 Fed. Reg. 16186, 3/25/16.