FDA To Examine Whether Abuse-Deterrent Formulas Curb Opioid Misuse
Next month, FDA Commissioner Scott Gottlieb will hold a two-day public meeting to address the issue.
The Food and Drug Administration (FDA) has called for a closer look into whether anti-abuse formulated opioid painkillers are actually preventing the misuse of prescription drugs.
FDA Commissioner Scott Gottlieb will convene a two-day public meeting for July 10 and 11, which will examine whether abuse-deterrent formulas—intended to reduce a drug's abuse potential—have contributed to a "real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse," according to a statement issued by the agency on June 13.
The meeting is the latest effort by Gottlieb to make good on his promise to make addressing the opioid epidemic the FDA's top priority, which he vowed during his Senate confirmation hearing in April 2017.
Gottlieb's decision adds to a mounting chorus of concern over whether anti-deterrent formulations are as effective as pharmaceutical manufacturers have claimed. The FDA itself is concerned over whether it has sufficient information to make such a determination; though it requires companies that market their drugs as abuse-deterrent to conduct post-approval studies—but compiling accurate data has proven difficult for an array of reasons.
Abuse-deterrent formulas are a relatively new innovation, and change on a fairly rapid and consistent basis, as does the means of evaluating how well they work. Much of the evidence for their efficacy can't be accurately measured, since abuse of such drugs happens in private and is not recorded or observed, rendering comprehensive data hard to come by.
More significantly, as the FDA has noted, there may not be any surefire way of preventing opioid drugs from being abused. "Abuse-deterrent" does not mean abuse-proof, and those that want to misuse medication cannot be entirely prevented from doing so. As an essay in the New England Journal of Medicine recently noted, there is an online community that provides instructions on how to tamper or alter medication with abuse-deterrent properties.
The FDA has made previous efforts to contend with abuse-deterrence problems, including the release of industry guidelines in 2015. Last week, the agency signaled that it was willing to take more direct steps to address the problem by issuing its first-ever request to a pharmaceutical manufacturer to remove one of its products from the marketplace over public health concerns.
The FDA determined that Endo Pharmaceuticals' painkiller, Opana ER, did not meet federal requirements for abuse-deterrent labeling due to reports that the drug was being injected by users, despite a reformulation that was supposed to prevent such abuse. Endo faces the possibility of losing the FDA's approval for the drug, which would then require the company to pull its product from shelves.