Responding to a slow conversion to abuse-deterrent formulations of opioids among prescribers, the Food and Drug Administration (FDA) this week indicated it will take several steps to bring additional safer versions of opioids to market and to encourage their use.
A guidance document issued on Nov. 21 offers drug makers new recommendations about the research they should conduct in order to demonstrate the relative safety of generic versions of abuse-deterrent formulations. A statement from Commissioner Scott Gottlieb, MD, reads that while provider unfamiliarity with abuse-deterrent drugs is partly responsible for their relatively low use, “we also know a significant barrier to use can be price.”
The FDA also indicated it will institute new review policies that will allow generic drug developers to discuss scientific and regulatory issues with the federal agency before submitting new drug applications. “These meetings will enable the FDA to clarify the agency's expectations early in the development process with the goal of reducing the time it takes to obtain approval,” the commissioner's statement reads.
In addition, the agency is conducting a study to determine whether use of the term “abuse-deterrent” properly conveys the benefits and limitations of these opioid formulations. “While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can't be abused, it's important that prescribers and patients understand that these drugs are not 'abuse-proof,' and they do not prevent addiction, overdose, or death,” the statement reads.
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