Statement from FDA Commissioner Scott Gottlieb, M.D., on agency's efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

SILVER SPRING, Md., July 20, 2018 /PRNewswire/ -- One of the ways that the U.S. Food and Drug Administration is working to address the opioid epidemic is by encouraging the development of opioid analgesic products that are harder to manipulate and abuse. Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding.

These innovative formulations are designed to make it harder for people to manipulate the opioid product so they can't be as easily abused to deliver an immediate "high." But it's important that prescribers and patients understand that these drugs are not "abuse-proof," and they do not prevent addiction, overdose or death.

We recognize that the science of abuse deterrence is relatively new, and we need to continue to study, and confirm, the potential role of ADFs in reducing the rate of misuse and abuse via different routes when used in a population. Both the formulation technologies and the methods for evaluating those technologies are rapidly evolving. We believe that transitioning from the current market, dominated by conventional opioid analgesics, to one where most opioids have abuse-deterrent properties may have the potential to further reduce misuse and abuse. While there are several of these products approved, their uptake has been slow among doctors who are treating patients in pain. One of the reasons for their more limited use is because these new formulations are currently only available as brand-name products, which are inherently more expensive than the numerous non-abuse-deterrent opioids that are also available in generic formulations. Many payers do not cover these ADF formulations.

Today, the FDA is posting a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations. In addition to the product-specific guidances issuing today, the FDA issued a final guidance last fall to assist industry in their development of generic versions of approved ADF opioids and support advancements in this area.

These product-specific guidances for ADF opioids are part of our continued work to encourage drug developers to bring safe, effective and high-quality generic products to market, including hard-to-copy complex generics and products that don't yet have generic competition. These product-specific guidances, when finalized, will describe the FDA's current expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs. The agency will continue to routinely post and revise product-specific guidances, including those for ADF opioids, as our goal is to decrease the rate of new addiction and to make the misuse and abuse of these drugs more difficult.

For more information:

Product-specific guidances for generic drug development

FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents; including hard-to-copy complex generics and abuse-deterrent formulations of opioids

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration