FDA issues draft guidance to support development of approved ADF opioids

Mar 25 2016

The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. Today's actions are among a number of steps the agency recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

"For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care," said FDA Commissioner Robert Califf, M.D. "We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy."

In today's guidance, the agency is 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. It does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose or death – notably, the FDA has not approved an opioid product with properties that are expected to deter abuse if the product is swallowed whole.

To better understand the real-world impact of ADF therapies and continue to support innovation in this space, the FDA has required all sponsors of brand name products with approved abuse-deterrent labeling to conduct long-term epidemiological studies to assess their effectiveness in reducing abuse in practice. While the FDA recognizes that the ADFs are not failsafe and more data are needed, ADF opioids do have properties expected to deter abuse compared to 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 draft guidance issued today (titled "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. Today's draft guidance for generic abuse-deterrent opioids follows the agency's final guidance for brand name opioids, "Abuse-Deterrent Opioids - Evaluation and Labeling," 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.

To encourage additional input from outside experts and the public, the agency will also hold a public meeting later this year to discuss the draft guidance on generic ADF products and a broad range of issues related to the use of abuse-deterrent technology as one tool to reduce prescription opioid abuse. The FDA will take this feedback into consideration when developing the final guidance on this topic.

"Collaboration is critical in fostering innovation in the field of abuse deterrence," said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "It is essential that a generic product is no less abuse-deterrent than the brand name product. We look forward to actively engaging in discussions to help inform our thinking about the evaluation of abuse-deterrent technologies."

The FDA encourages feedback from all stakeholders during the 60-day comment period on this draft guidance.