FDA Science Board Addresses US Opioid Epidemic

Posted 01 March 2016 By Zachary Brennan

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The US Food and Drug Administration’s (FDA) Science Board met Tuesday to discuss pain management and opioid abuse, offering a number of ways to address a topic that’s caught the attention of Congress as overdose deaths mount.

At the outset of the meeting, newly confirmed FDA Commissioner Rober Califf told the panel -- which is advising FDA on the role of pharmaceuticals in pain management, development of alternative medications and postmarketing surveillance activities – that the agency will look to back more opioids that have abuse-deterrent properties.

The meeting comes as part of a full push from the agency to reevaluate how it regulates opioids and other pain medications as Congress has taken issue with the agency for approving the use of opioids for younger patients and not listening to the advice of its expert committees in approving some opioids.

Three top FDA officials –Califf, former acting commissioner Stephen Ostroff and CDER Director Janet Woodcock – wrote in a New England Journal of Medicine special report recently that FDA continues “to be deeply concerned about the growing epidemic of opioid abuse, addiction, and overdose — an epidemic directly related to the increasingly widespread misuse of powerful opioid pain medications.”

And regardless of whether these issues with opioids are viewed from the perspective of patients, physicians, or regulators, “the status quo is clearly not acceptable,” the officials said.

More than 30 active investigational new drugs (INDs) with abuse-deterrent properties or new technologies are under review at FDA, including ones that use pH technology that requires the acidic environment of the stomach to release the opioid. But a number of experts noted that abuse deterrent technology is not a panacea, especially as there was a spike in the number of heroin overdoses as abuse-deterrent opioids first hit the market in the US.

Science Board

At the meeting Tuesday, Woodcock noted that one of the issues is a “lack of understanding of chronic pain,” meaning that traditional drug discovery methods often don’t yield good new candidates for treating chronic pain.

“Our armamentarium for chronic pain is limited, that’s why we’re seeing all this opioid usage,” Woodcock said.

Dr. Daniel Alford of Boston University School of Medicine, one of the outside experts presenting at the meeting, told FDA: “Treating chronic pain like acute pain is a road to failure.”

Chronic pain has been treated with an “opio-centric” mindset, despite its long-term effectiveness not being studied, Alford said, noting that data on chronic pain in the US shows that somewhere between 11% and 31% have chronic pain annually.

Dr. Douglas Throckmorton, deputy director for regulatory programs at CDER, said FDA is working to pool opioid monitoring statistics together and to enroll hospitals to collect health data, though national estimates for 2015 will likely come out in 2017. FDA is also working with CDC to develop the capability to identify specific drug names from death certificates to more accurately track opioid misuse.

He also said FDA is reassessing how it thinks about the risks and benefits of new opioids up for approval.

Dr. Daniel Clauw of the University of Michigan School of Medicine raised concerns about patients who are started on opioids in the emergency department or after a surgery but then stay on these medications for months after their initial use for “emotional pain or other pains.”

But as far as what FDA can do specifically, no clear answers were at hand. Califf said near the end of the meeting: “One thing that’s difficult for us is the limited arsenal that we have – I’m completely in favor of mandatory training around opioids, but we can’t deliver mandatory training for 200,000-300,000 providers, that’s a decision the ecosystem will have to make.”

Comprehensive Addiction and Recovery Act

The Science Board’s meeting comes as the Senate this week moved forward a bill that would strengthen prescription monitoring programs and provide more education and treatment options for those with addiction concerns.

Sen. Jeanne Shaheen (D-N.H.) has said she will call for $600 million in emergency funding for the bill, though there seems to be disagreement over how the bill would proceed if funding is not included.

The Congressional Budget Office estimates that authorizing the grants under the bill would require appropriations of $413 million between 2017 and 2021.

Sen. Joe Manchin (D-WV), who spoke in the public hearing of the Science Board meeting, on Tuesday also introduced five amendments to the bill, including one that specifies that if FDA approves a drug against the advice of an advisory committee, the agency would be required to submit a report to Congress justifying the decision.

Another Manchin amendment would establish a 1 cent fee on each milligram of active opioid ingredient in a prescription pain pill to be paid by the manufacturer or importer. The funds raised would be used to pay for efforts to provide and/or expand access to substance abuse treatment and would be distributed as part of the Substance Abuse Prevention and Treatment Block Grant. 

Science Board Meeting Background Materials

 

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Categories: Drugs, Crisis management, Due Diligence, Manufacturing, Postmarket surveillance, Project management, News, US, FDA

Tags: opioid, heroin, opioid overdose, FDA and opioid, Zohydro, Manchin

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