US FDA issues draft guidance for abuse-deterrent generics
Regulator is encouraging industry efforts to develop pain medicines that are more difficult to abuse
The US Food and Drug Administration aims to clamp down on opioid abuse and has issued a draft guidance for abuse-deterrent formulations (ADF) of opioid generics, including a recommendation that studies should be conducted to demonstrate that generic opioids are no less abuse-deterrent than branded drugs.
The FDA said it was encouraging industry efforts to develop pain medicines that are more difficult to abuse.
Abuse-deterrent properties 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.
To better understand the impact of ADF therapies and continue to support innovation in this area, the FDA requires all manufacturers of branded products with approved abuse-deterrent labelling to conduct long-term epidemiological studies to assess their effectiveness in reducing abuse in practice.
While the FDA recognises that the ADFs are not failsafe and more data are needed, they do have properties that are expected to deter abuse compared with non-ADFs.
Given the lower cost, on average, of generic products, encouraging access to generic forms of ADF opioids is an important step toward balancing the need to reduce opioid abuse with helping to ensure access to appropriate treatment for patients in pain, the FDA said.
The draft guidance, 'General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products', includes recommendations about the studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product, with respect to all potential routes of abuse.
This advice follows the agency's final guidance for brand name opioids, 'Abuse-Deterrent Opioids – Evaluation and Labelling,' which was issued April 2015 as the first step to provide a framework for what studies were needed to test a product's ability to deter abuse.
The FDA is encouraging feedback from all stakeholders during the 60-day comment period on this draft guidance.
