Today, in the Federal Register, FDA is announcing 2 upcoming meetings of the Pediatric Advisory Committee (PAC) that relate to the use of prescription opioid analgesics in pediatric patients The FDA is calling on a broad range of independent experts with real-world experience to provide recommendations on how to address the unique needs of children in pain. The joint meeting in September will include experts from the FDA’s Pediatric Advisory Committee, Anesthetic and Analgesic Drug Products Advisory Committee, and Drug Safety and Risk Management Advisory Committee. Topics to be discussed at the September meeting will include the development of high-quality evidence to guide treatment, pediatric labeling for opioids, and improving practice to reduce addiction, misuse, and abuse. The FDA encourages feedback and input and has opened a docket for public comment on this meeting.
The April Pediatric Advisory Committee meeting will provide an opportunity for the Committee and the public to hear the proposed framework for the September discussion. Both meetings will include an open public hearing and there will be an open public comment period to allow for patients, their families and health care providers to provide their input as well.
The FDA will carefully weigh the advice and recommendations of its independent Advisory Committees, as well as input from the public, as part of the Agency’s broad reassessment of current and future actions related to the review and approval of pain medications for use in children.
For more information:
- April 12, 2016 meeting FR notice https://www.federalregister.gov/a/2016-03469.pdf
- September 15 &16, 2016 meeting FR notice https://www.federalregister.gov/articles/2016/02/19/2016-03468/meetings-anesthetic-and-analgesic-drug-products-advisory-committee-the-drug-safety-and-risk