FDA and Opioid Policy

FDA Unveils Sweeping Changes to Opioid Policies

In response to the ongoing opioid abuse epidemic, top officials at the US Food and Drug Administration (FDA) today announced plans to reassess the agency's approach to opioid medications.

"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Robert Califf, MD, the FDA's Deputy Commissioner for Medical Products and Tobacco, said in a news release. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."

The plan is further outlined in an article published online today in the New England Journal of Medicine.

"Nationally, the annual number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents," write Dr Califf and coauthors Janet Woodcock, MD, and Stephen Ostroff, MD, also from the FDA. "Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable. As the public health agency responsible for over-sight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions. We are committed to action, and we urge others to join us."

The multicomponent plan will focus on policies aimed at reversing the epidemic, while still providing pain patients access to effective medication. Specifically, the FDA plans to:

  • Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public-health effects;
  • Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;
  • Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;
  • Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to those of the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;
  • Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;
  • Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;
  • Improve access to naloxone and medication-assisted treatment options for patients with opioid-use disorders; and
  • Support better pain-management options, including alternative treatments.

The FDA says they will seek guidance from outside experts in the fields of pain management and drug abuse. The agency has already asked the National Academy of Medicine to assist in developing a framework for opioid review, approval, and monitoring that balances an individual's need for pain control with considerations of the broader public-health consequences of opioid misuse and abuse.

The FDA says it will convene independent advisory committees made up of physicians and other experts when considering approval of any new opioid drug that does not contain abuse-deterrent properties. The agency will also convene a meeting of its standing Pediatric Advisory Committee to provide advice on a framework for pediatric opioid labeling and use of opioid pain medications in children.

The FDA also plans to tighten requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids, an action, they say, that will generate the "most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose and death."

Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States.

"Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence," Dr Califf said in the FDA statement. "It's time we all took a step back to look at what is working and what we need to change to impact this crisis."

"Agencies from across the Department of Health and Human Services and throughout the federal government are united in aggressively addressing this public health crisis," US Health and Human Services (HHS) Secretary Sylvia M. Burwell, said in the news release. "The FDA is a vital component to combating this epidemic, and the innovation and modernization they have committed to undertaking is an important part of the overall efforts at HHS."

Last spring, HHS announced a major initiative to address the opioid abuse epidemic in the US. The initiative focuses on informing opioid prescribing practices, increasing the use of naloxone, and using medication-assisted treatment to move people out of opioid addiction.

The FDA says it will provide updates on progress with the goal of sharing timely, transparent information on a regular basis.

NEJM. Published online February 4, 2016. Abstract

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