FDA Officials Propose Strategy for Tackling Prescription Opioid Epidemic

As the public health agency responsible for oversight of pharmaceutical safety and effectiveness, the Food and Drug Administration (FDA) recognizes the role it will need to play in creating solutions to the current prescription opioid abuse epidemic, the agency’s top officials wrote in a special report published February 4 in the New England Journal of Medicine.

While the officials noted a comprehensive solution to the opioid crisis will require partnerships between multiple government agencies, clinicians, the medical products industry, and more, they called for a far-reaching action plan to reassess the agency’s approach to opioid medications.

“As FDA leaders and as physicians, we believe that these efforts must be founded on two complementary principles: that the United States must deal aggressively with opioid misuse and addiction, and at the same time, that it must protect the well-being of people experiencing the devastating effects of acute or chronic pain,” Robert Califf, M.D., then the FDA’s deputy commissioner for medical products and tobacco, and other top officials wrote. (On February 24, Califf was named commissioner of food and drugs.)

According to the FDA, over the course of a given year, approximately 100 million people in the United States suffer from pain, with some 9 million to 12 million of them having chronic or persistent pain. The Centers for Disease Control and Prevention estimates that about 19,000 people died from overdoses associated with prescription opioid pain medications in 2014.

“We must care for our most vulnerable patients, but we must also do everything possible to avoid both the inappropriate prescribing of powerful opioid medications and the misuse of these prescriptions,” agency leaders wrote.

In a press release, the agency committed to the following measures aimed at stopping the opioid epidemic:

• Reexamining the risk-benefit paradigm for opioids and ensuring that the agency considers the drugs’ wider public health effects.

• Convening an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.

• Assembling and consulting with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved.

• Developing changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required.

• Updating Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements.

• Expanding access to, and encouraging the development of, abuse-deterrent formulations of opioid products.

• Improving access to naloxone and medication-assisted treatment options for patients with opioid use disorders.

• Supporting better pain management options, including alternative treatments.

To help achieve these goals, the FDA said it will seek guidance from outside experts in the fields of pain management and drug abuse. The agency recently requested that the National Academies of Sciences, Engineering, and Medicine help develop a framework for opioid review, approval, and monitoring.

In addition, the FDA is strengthening the requirements for drug companies to provide postmarketing data on the long-term impact of using ER/LA opioids, which the agency stated it hopes will “result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder … [and] further the understanding of the known serious risks of opioid misuse, abuse, overdose, and death.”

Erin Zerbo, M.D., an assistant professor of psychiatry at Rutgers New Jersey Medical School, told Psychiatric News that while the FDA’s proposed label changes and advisory committees are a good start, she would also like to see some initiatives addressing nationwide—as well as statewide—prescription monitoring programs since prescribing practices are a crucial factor monitoring for opioid misuse.

“We need to make sure we’re targeting the on-the-ground, day-to-day issues that physicians face when prescribing these medications—such as screening for opioid use disorders and preventing ‘doctor shopping,’” she said. “It’s crucial to target this epidemic from both ends: to help prevent and address the onset of an opioid use disorder and to provide appropriate treatment once an opioid use disorder has developed.”

“These steps by the FDA are long overdue and are all in the right direction,” John Renner, M.D., an associate professor of psychiatry at Boston University School of Medicine and vice chair of the APA Council on Addiction Psychiatry, told Psychiatric News. He noted that while the proposed changes are unlikely to directly impact most psychiatrists, they may bolster the development of nonpharmacologic options for managing pain and improve access to naloxone and medication-assisted treatments for patients with opioid use disorders. ■