FDA makes sweeping changes for opioids

February 8, 2016

After receiving pressure from Congress, FDA announced several measures aimed at curbing opioid abuse. The new plan calls for increasing abuse-deterrent formulations of opioid medications and upping access to naloxone and alternative pain treatments.

After receiving pressure from Congress, FDA announced several measures aimed at curbing opioid abuse. The new plan calls for increasing abuse-deterrent formulations of opioid medications and upping access to naloxone and alternative pain treatments.

The Obama administration also asked Congress to spend $1.1 billion next year to curb opioid abuse and increase treatment facilities.

Related: [BLOG]: Use and abuse of opioids: FDA responds

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” said Dr. Robert Califf, acting FDA commissioner. “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.”

However, Senator Edward Markey (D-Mass.) and other U.S. legislators are still blocking Califf’s nomination to FDA commissioner, over what Markey called the agency’s limp response to the drug problem.

Related: FDA: Final guidance on evaluation, labeling of abuse-deterrent opioids

Meanwhile, the new plan will focus on policies aimed at reversing the epidemic, while still providing patients who are in pain access to effective relief, according to FDA. As part of the new opioid plan, the agency will:

  • 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.

  • Support better pain management options, including alternative treatments

  • Develop 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.

  • 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.

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

  • Strengthen the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. “The agency expects this to result in 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,” according to the FDA statement.

 “We are determined to help defeat this epidemic through a science-based and continuously-evolving approach,” Califf said. “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.”

Read more: Drop in opioid Rx, overdoses linked to pharmacy changes