Congress Pressures FDA to Finalize Opioid Guidance
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.
Rogers is chair of the House Appropriations Committee.
“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 told MedPage Today 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 was initially 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.
Filed under: General Problems
I have a friend who is unable to swallow pills and is already severely limited on medications, as she is unable to access any ER meds. Now, with the issue with pharmacies, I don’t know what people in her condition, are suppose to do. Although, I sure don’t want the monies being transferred from the FDA; we all know that will only end with more harassment of legitimate healthcare providers! Seems to me, it is always the law abiding citizen who suffers from the government trying to solve social problems!
Seriously I know I’m an idiot for even thinking the FDA has any brains, but IF they do, I hope they consider those patients who are unable to take abuse deterrent formulations and not totally lock them out of choices for pain management. Patients such as those with malabsorptions issues like Crohns, gastric bypass, ostomies, patients who need crushed meds now and then such as LTC, elderly, and hospice. It really sounds like what they want is 100% abuse deterrent in everything that comes out on the market which if we are lucky, we MIGHT get liquids and injectibles….yeah rah….not alot of choice…morphine and oxycodone for liquid and morphine, dilaudid (bad for the elderly) and fentanyl for injection and fentanyl patches. My nurses will be doing nothing but running up and down halls dosing narcotics every 2,3,4 hrs in alot of cases to keep residents comfortable in the forseeable future. Not much of a future. Besides everytime they try and build a better mousetrap, the mice always find a better way around the trap to get the cheese. ALWAYS