WASHINGTON — The FDA on Tuesday issued a final guidance document to help companies develop generic versions of approved abuse-deterrent opioids.
FDA Commissioner Scott Gottlieb said in a statement that the guidance was “one piece of the FDA’s ongoing work aimed at finding solutions to combat the opioid crisis.”
Although the agency would ultimately like to reduce the number of people addicted to opioids by decreasing exposure to them, “we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives,” said Gottlieb. “Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.”
The FDA has so far approved 10 opioids in abuse-deterrent formulations (ADFs), but uptake has been slow, he noted. “The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions.”
“But we also know a significant barrier to use can be price,” which is why encouraging generic versions of these drugs is so important, he continued. “Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations.”
The guidance issued on Tuesday “includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart,” Gottlieb said. “We’re also taking additional steps beyond the new guidance to help developers of generic ADFs navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable.”
Finally, “we are also focusing new efforts on the development and promotion of medication-assisted treatments for addiction,” he concluded. “As we balance the need to effectively treat pain with the public health emergency related to opioid addiction, we must find creative ways to prevent new cases of abuse and addiction.”