FDA Science Advisors Talk Strategy on Opioids – MedPage Today

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When it comes to opioid policy, the FDA has a risk communication problem on its hands, according to two members of its science board.

From their outsider perspective — one member is in veterinary medicine, the other in food safety — the agency isn’t telling patients and providers what they need to know, they stated.

“It’s clear there are big gaps in the research when it comes to pain and the use of opioids,” said Lisa Nolan, PhD, of Iowa State University in Ames. “If I were faced with the decision to take opioids, after today, I want someone who can lay out the risks and benefits for me. I want to make sure that my physician clearly understood the risks.”

Barbara Kowalcyk, PhD, of the Center for Foodborne Illness in Grove City, Pa., said that while it’s a complicated problem, it’s clear that “you don’t have patients and prescribers who understand the risks.”

“It strikes me that you have a serious risk communication problem on your hands,” she said. “You need informed patients and informed prescribers. Rather than a continuing education issue, you need to look at this as a risk communication issue.”

The agency has a mandatory Risk Evaluation and Mitigation Strategy (REMS) for long-acting extended-release (ER/LA) opioids, which it says has delivered continuing education to tens of thousands of healthcare providers on safe opioid prescribing. Experts involved in the meeting acknowledged the lack of evidence for long-term use of opioids in chronic, non-cancer pain.

The suggestion about risk communication was one of several posed to the FDA during a meeting of its Science Board, which the agency called to learn about additional strategies it can deploy to combat the opioid addiction epidemic. Last month, the agency said it was reassessing its policy regarding opioids — in what some say was a small concession during a political battle over the appointment of its new commissioner, Robert Califf, MD.

The discussion at the meeting was wide-ranging, from opioids and addiction science to chronic pain and the need for new pain therapies. Presentations were made by FDA officials and academics. During a nearly 2-hour open public comment period, Sen. Joe Manchin III (D-W.Va.), a vocal critic of Califf’s appointment, detailed opioid addiction problems in his home state and criticized the agency’s reliance on enriched enrollment procedures to get opioids approved.

During a scheduled talk, Sharon Hertz, MD, director of the FDA’s anesthesia, analgesia, and addiction products at its Center for Drug Evaluation and Research (CDER), described the two public-private partnership organizations that developed enriched enrollment — ACTTION and IMMPACT — as key components for improving development of pain drugs (the hydrocodone-only drug product Zohydro was approved via this mechanism).

Hertz and other speakers acknowledged that on the flip-side of the nation’s opioid addiction problem is the lack of understanding of pain and the need for better treatments. Hertz said there’s a dearth of good treatments for pain; doctors only have nonsteroidal anti-inflammatory drugs (NSAIDs), anticonvulsants, antidepressants, and opioids, as well as some other therapies less commonly used, including capsaicin and a topical lidocaine patch, in their armamentarium.

Janet Woodcock, MD, director of CDER, said the agency needs to balance the risk of harm with the need for pain relief. “We need new pain medications, and a better understanding of pain,” she said.

Califf highlighted some of the agency’s efforts thus far, including the approval of new formulations of the opioid overdose reversal agent naloxone, and forcing opioid drugmakers to conduct a total of 11 postmarketing studies that will look into abuse, addiction, and overdose.

“I think these 11 studies will answer a lot of our questions” regarding the lack of evidence base on long-term use of opioids in chronic non cancer pain, he said.

Califf also recapitulated the agency’s latest action on opioids, which included convening the current meeting, as well as changes to immediate-release opioid labeling; advisory committees for all opioids that don’t have abuse-deterrent formulations; and additional post-marketing study requirements.

Douglas Throckmorton, MD, deputy director for regulatory programs at CDER, provided additional details on his division’s opioid strategy, including improved regulatory, policy, and scientific goals as well as better communication.

Throckmorton also noted that an FDA advisory committee will meet in May to assess 3-year data on the quality of the agency’s REMS program for ER/LA opioids.

Science Board Chair Bruce Psaty, MD, PhD, MPH, of the University of Washington in Seattle, concluded the meeting by acknowledging that “opioid use and abuse is an incredibly difficult problem.” But he added that the FDA “doesn’t manage the practice of medicine so there are a limited number of things it can do.”

“There are no easy solutions,” Psaty said. “This meeting is part of a process, and I’m delighted to start the process here.”

FDA Science Advisors Talk Strategy on Opioids – MedPage Today