FDA Takes Steps to Broaden Access to Generic Abuse-Deterrent Opioid DrugsBy
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has provided an update on the agency’s plans to increase access to abuse-deterrent opioid drugs by facilitating development of generic versions of these drugs.
“While there are several of these products approved, their uptake has been slow among doctors who are treating patients in pain,” Gottlieb said in a July 20, 2018 agency statement. “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 [abuse-deterrent formulation] formulations.”
On July 20, the FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products to identify appropriate science-based methodologies and evidence for developing generics. The batch contains 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe the FDA’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their respective reference-listed drugs. Ten of the new draft guidances and six of the revised guidances are for complex drug products, including multiple products that do not yet have generic competition. This batch of guidances also includes three revised product-specific guidances for ADFs of opioids.
These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations. In addition to the product-specific guidances issued, the FDA issued a final guidance last fall (2017) to assist industry in their development of generic versions of approved ADF opioids and support advancements in this area.
“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,” Gottlieb said in his statement.