FDA Calls for Sweeping Review of Opioids Policies

FDA Calls for Sweeping Review of Opioids Policies

Top officials for the organization have called for an action plan to reassess the agency's approach to opioid medications. FDA also will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.

Dr. Robert Califf, deputy commissioner for Medical Products and Tobacco for the FDA, and other top agency officials have called for an action plan to reassess the agency's approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic while still providing patients access to effective relief.

FDA will also seek outside guidance from experts in pain management and drug abuse.

"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," said Califf. "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 agency also is making the requirements for drug companies to generate postmarket data stronger, resulting in more comprehensive data with regards to pain medicine and treatments for opioid use disorder.

"Agencies from across the Department of Health and Human Services and throughout the federal government are united in aggressively addressing this public health crisis," said U.S. Health and Human Services Secretary Sylvia M. Burwell. "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."

FDA indicated it will re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects and also will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.

FDA reported it already has asked the National Academies of Sciences, Engineering, and Medicine to help develop a framework for opioid review, approval, and monitoring, a framework that balances individuals' need for pain control with considerations of the broader public health consequences of opioid misuse and abuse.

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