A meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will take place on June 11 and June 12.
The focus of the meeting will be safety concerns with the increase in opioid analgesic dosing in outpatient treatment. The Food and Drug Administration (FDA) wants to explore the situations where higher doses are needed, and the side effects outweigh the benefits. The FDA worries about the use of higher doses of opioids both for the patient and anyone else who may have access to the drug.
The three points the FDA wants to discuss at the June meeting are: 1) clinical situations where pain management requires higher doses of opioid medications and specific patient populations where opioids are more often prescribed; 2) the magnitude and frequency of harmful consequences compared to lower strengths; and 3) the impact of possible FDA interventions.
Meeting materials will be available from the FDA two business days before the start of the meeting on its website and onsite.
The docket number for public comment is FDA-2019-N-146 and will be open until June 30 through written or electronic comments. Those comments received by May 28 will be given to the Committee and the comments received between May 28 and June 30 will be made available to the FDA.
Electronic submissions may be submitted either at the Federal eRulemaking Portal (regulations.gov). Paper submissions should be sent to Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Maryland. Confidential comments must be written and contain the note “This document contains confidential information”.
The meeting will take place at the FDA White Oak Campus 10903 New Hampshire Avenue, Building 31 Conference Center, The Great Room (Rm. 1503), Silver Spring, Maryland.
