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FDA Seeks Input on Opioid Analgesic Dosing

FDA Seeks Input on Opioid Analgesic Dosing

Thursday, June 20, 2019

The US Food and Drug Administration (FDA) is seeking public input on the clinical utility of and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. The FDA’s stated purpose is to better understand current clinical use and situations that may warrant use of higher doses of opioid analgesics. Additionally, they are interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients.

On June 11th and 12th, the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee convened a joint meeting to discuss this issue and receive in-person comments. The FDA also created a docket (FDA-2019-N-1646) for public comment which is open through June 30, 2019. To date, more than 1,000 comments have been registered.

“In particular, FDA seeks to discuss: (1) The current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose.”

If you are interested in providing input, submit your electronic comments via the electronic filing system or written comments at: 

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.

All submissions received must include the Docket No. FDA-2019-N-1646 for “Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments filed in a timely manner will be placed in the docket and publicly viewable. There is also a process by which comments can be submitted as “Confidential Submissions.” 

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