FDA releases steps to ensure safety of abuse-deterrent generic opioids

On March 24, 2016 the Food and Drug Administration (FDA) announced draft guidance for generic versions of approved abuse deterrent formulations (ADF).  The guidance, which is focused on creating policies to address the opioid epidemic, comes out of the action plan that the FDA created in April, 2015 to begin reevaluating the approach to prescription opioids.

The new guidance provides recommendations for demonstration that a generic opioid medication is at least as abuse deterrent as its referenced brand name product and is a major step towards increased accountability regarding generic versions of solid oral opioid products with the potential for abuse.  While this guidance is a recommendation for industry, and not legally enforceable, we believe it is the precursor to greater awareness of the need for management of generics that claim to have abuse deterrent properties.

This awareness is critical in order to combat widespread opioid abuse. Federal guidelines for branded abuse deterrent formulation opioids are stringent, and becoming more so each day; as providers, healthcare organizations, local, state, and federal governments seek to minimize the growing impact of prescription and street opioid drug abuse.  However, companies producing generic opioids have not yet been required to receive ADF labeling.  Many feel that as long as generics are not formulated as ADFs, it’s almost impossible to affect the abuse epidemic. Abusers can simply choose a non-abuse deterrent generic over a branded ADF.

As branded ADFs currently have only an approximate 5% of the market, this draft guidance, and future FDA guidance on this topic, should be a positive step toward controlling opioid abuse and misuse in the future.

For more information on this guidance, please see: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products) which outlines recommended guidelines to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product.

The agency’s final guidance for brand name opioids, Abuse-Deterrent Opioids – Evaluation and Labeling, provides guidelines to test a product’s ability to deter abuse.