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March 24, 2016

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for supporting pharmaceutical industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF). At the same time, FDA wants to ensure that generic ADF opioids are no less abuse-deterrent than the brand-name drugs. The plan is focused on policies toward reversing the epidemic, and at the same time providing patients access to effective relief who are tremendously suffering from pain.

At present, the agency is inspiring the efforts of the industry for developing pain medicines that are tougher to abuse. For instance, efforts like crushing a tablet so as to snort the contents or dissolving a capsule for injecting its contents will be less rewarding or more difficult. However, it does not mean that the product will be impossible to abuse or will certainly prevent addiction, overdose, or death.

As argued by Robert Califf, M.D., the FDA Commissioner: “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. 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.”

The FDA has required all sponsors of brand name products with approved abuse-deterrent labeling to conduct long-term epidemiological studies for assessing their efficacy in reducing abuse in practice in order to better understand the real-world impact of ADF therapies and continue to support innovation in this space. Although FDA understands that the ADFs are not failsafe and more data are needed in this regard, ADF opioids are capable of deterring abuse more than the non-ADFs. Encouraging access to generic forms of ADF opioids is a vital step toward balancing the need to reduce opioid abuse with ensuring access to appropriate treatment for patients in pain, given the lower cost of the generic products on average.

The draft guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products” contains recommendations for the pharmaceutical companies about the studies that they should conduct to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product, with respect to all potential routes of abuse. FDA will also hold a public meeting later this year for discussing about this draft guidance and also a broad range of issues regarding the use of abuse-deterring technology for reducing prescription opioid abuse.

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