FDA's Draft Guidance Promotes Generic Abuse-Deterrent Opioids

The FDA has issued a draft guidance that encourages the industry's production of generic versions of opioids with abuse-deterrent formulations, while making sure they are as safe as their brand-name counterparts.

The FDA has issued a draft guidance that encourages the industry's production of generic versions of opioids with abuse-deterrent formulations, while making sure they are as safe as their brand-name counterparts.

The FDA stated its goal was to ensure that the generic drugs are no less abuse-deterrent than the brand-name versions on the market.

“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 in the press release. “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 acknowledged that abuse-deterrent formulations may still lead to addiction, overdose, or death, but the abuse-deterrent properties can make it harder for an individual to crush, snort, or dissolve a product. Currently, there are not FDA-approved opioid products that are expected to deter abuse if the product is swallowed whole.

The FDA is requiring all sponsors of brand-name products with abuse-deterrent labeling to conduct long-term epidemiological studies to determine the impact of abuse-deterrent methodologies.

The draft guidance includes specific recommendations about the studies to evaluate whether a generic opioid is no less abuse-deterrent than the brand-name product.

The administration encouraged feedback from stakeholders during the 60-day comment period on this draft guidance.

A public meeting later this year will also help the FDA as it creates the final version of the guidance.