Drugs

Further FDA Opioid Crisis Strategies: Califf

David McFarland

— 1 min read
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FDA commissioner Robert Califf says that as the agency considers ways to implement recommendations in a report evaluating its efforts to address the nation’s opioid crisis, it is “already moving forward on multiple workstreams, while also adapting to the changing epidemiology of the ongoing public health emergency.” Califf’s online statement references a report from subject matter experts at the Ohio State University that examined FDA’s implementation of recommendations in a 2017 review by the National Academies for Sciences, Engineering, and Medicine (NASEM), along with key regulatory policies and decisions.

The Ohio State report says that in the last five and a half years, FDA “has made clear, important progress on implementing the NASEM committee’s recommendations across the board. Even with this progress, however, FDA has recognized that the drug overdose crisis is dynamic in nature and there is, and for the foreseeable future, there will continue to be, more work to be done.” The report recommends that FDA:

  • continue its efforts to comprehensively implement the recommendations in the NASEM report, including evaluating scientifically sound, inclusive study designs to inform a systems approach for regulatory decision-making that incorporates public health considerations;
  • consider seeking from Congress certain additional authorities regarding opioid analgesic approvals and the review of advertising and promotion for such products, as well as additional resources to implement such activities, to strengthen the agency’s oversight of prescription drug analgesics; and
  • be as transparent as possible about its decision-making for opioid analgesics, as increased transparency can encourage appropriate uses of prescription opioid analgesics, promote innovation in pain management and prevention of opioid use disorders, and enhance public trust.

Califf writes that steps already being taken include:

  • strengthening evidence generation within FDA and with multiple partner organizations to better inform the response to the opioid crisis;
  • deepening understanding of the long-term efficacy of opioid analgesics;
  • exploring the need for potential new legal authorities for opioid approval standards, including whether drug developers seeking approval for the marketing of new opioid analgesics should be required to demonstrate that their products offer material safety advantages over existing approved opioid analgesics;
  • exploring ways to use current authorities not only to regulate opioids more effectively but also to improve the pipeline of non-addictive pain treatments; and
  • continuously working to earn and retain the public’s trust by increasing transparency through improving advisory committee meetings.

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