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.

Download Center

  • OSHA Recordkeeping Guide

    In case you missed it, OSHA recently initiated an enforcement program to identify employers who fail to electronically submit Form 300A recordkeeping data to the agency. When it comes to OSHA recordkeeping, there are always questions regarding the requirements and ins and outs. This guide is here to help! We’ll explain reporting, recording, and online reporting requirements in detail.

  • Incident Investigations Guide

    If your organization has experienced an incident resulting in a fatality, injury, illness, environmental exposure, property damage, or even a quality issue, it’s important to perform an incident investigation to determine how this happened and learn what you can do to prevent similar incidents from happening in the future. In this guide, we’ll walk you through the steps of performing an incident investigation.

  • Lone Worker Guide

    Lone workers exist in every industry and include individuals such as contractors, self-employed people, and those who work off-site or outside normal hours. These employees are at increased risk for unaddressed workplace accidents or emergencies, inadequate rest and breaks, physical violence, and more. To learn more about lone worker risks and solutions, download this informative guide.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Download the guide to learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • The Basics of Incident Investigations Webinar

    Without a proper incident investigation, it becomes difficult to take preventative measures and implement corrective actions. Watch this on-demand webinar for a step-by-step process of a basic incident investigation, how to document your incident investigation findings and analyze incident data, and more. 

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - November December 2022

    November December 2022

    Featuring:

    • IH: GAS DETECTION
      The Evolution of Gas Detection
    • OSHA TOP 10
      OSHA's Top 10 Most Frequently Cited Standards for FY 2022
    • FALL PROTECTION
      Enhance Your Fall Protection Program with Technology
    • 90TH ANNIVERSARY
      The Future: How Safety WIll Continue to Evolve
    View This Issue