Congress Pressures FDA to Finalize Opioid Guidance

This is some general information for our pain providers.

Threatens to shift $20 million from agency if abuse-deterrent guidance isn’t settled by June.

The FDA will publish its long-awaited guidance on abuse-deterrent opioids by the end of June, in order to avoid a $20 million cut in funds to the commissioner’s office threatened by Congress.

An amendment by Hal Rogers (R-Ky.) to the “Cromnibus” appropriations bill passed last December requires that the guidance be finalized by June 30, otherwise $20 million will be moved from the salaries and expenses section of the FDA Commissioner’s office to its criminal investigations department to combat drug diversion.

“It’s a lot of money and the FDA is going to respond to that,” said Dan Mendelson, CEO of Avalere Health, a firm that tracks healthcare policy. “You always try to get rid of language like that because it does tie your hands.”

Indeed, an FDA spokesperson said that the organization “is aware of the provision and we are working to finalize the guidance before the June 30, 2015 deadline.”

Guidance for developing abuse-deterrent opioids has been a long time coming. It wasinitially released in January 2013, but the agency didn’t hold a workshop on the draft document a 2-day meeting last October.

While it’s unclear what the final language will be, the agency noted last fall that it plans to continue to evaluate approvals on a case-by-case basis — citing the fact that the science of abuse-deterrence is still unsettled.

In the meantime, four opioids have been approved with abuse-deterrent labeling:Targiniq, Hysingla, and reformulated Oxycontin from Purdue Pharma, and abuse-deterrent Embeda from Pfizer.

A reformulated version of Zohydro was approved but does not have abuse-deterrent labeling.
Zohydro, which is pure hydrocodone, was initially approved without any abuse-deterrence mechanism, setting off a firestorm of controversy.

Approvals of generic abuse-deterrent opioids have also been inconsistent; while FDA removed generics of OxyContin from the market once Purdue created an abuse-deterrent formulation, it did not do the same for Opana generics. The FDA did not give Endo Pharmaceuticals a label indication for abuse-deterrence for Opana.