Packaging, Storage, and Disposal Options to Enhance Opioid Safety-Exploring the Path Forward

The purpose of the public workshop is to host a scientific discussion with expert panel members and interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems (e.g., a closed system such as the U.S. Department of Veterans Affairs); data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings; and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.

Date:

December 11, 2017 from 8:30 a.m. to 5:00 p.m.
December 12, 2017 from 8:30 a.m. to 5:00 p.m.

Location:

Sheraton Silver Spring Hotel
8777 Georgia Avenue
Silver Spring, MD 20910
Telephone: 301-589-0800

Meeting Materials:

• Federal Register Notice
• Meeting Agenda
• List of FDA Panelists
• List of External Panelists
• Disclosure Forms

Presentations:

• Session 1 Target Problems
  Irene Z. Chan, PharmD
• Session 2 Design Considerations
  Gary Slatko, MD
• Session 3 Regulatory Considerations
  Patrick Raulerson, JD
• Session 4 Integrating Options into Med Use System
  Kayla Cierniak, PharmD, MS
• Opening Session Day 2 Premarket Data and Labeling Considerations
  Irene Z. Chan, PharmD 
• Opening Session Day 2 Postmarket Data
  Tamra Meyer, PhD, MPH
• Session 5 Poison Prevention, Product Safety, and Development
  Laura Bix, PhD
• Session 5 Unsupervised Ingestion by Young Children
  Daniel Budnitz, MD, MPH
• Session 6 Improving Med Adherence through Innovative Packaging
  Walt Berghahn
• Session 7 Parallels with Human Abuse Liability Studies
  Dominic Chiapperino, PhD

Webcast of the Public Workshop:

The archived webcasts of the 8 sessions of the public workshop are available on the link below:

• http://jmp.sh/lRhfwQS

Transcripts

The transcripts of the public workshop are now available below, and accessible online at https://www.regulations.gov/document?D=FDA-2017-N-5897-0016

• Transcript: Monday, December 11, 2017 (PDF - 811KB)
• Transcript, Tuesday, December 12, 2017 (PDF - 941KB) 

Comments on the Public Workshop:

Please refer to the Federal Register Notice on instructions for submitting either electronic or written comments on this public workshop. The deadline for comments is March 16, 2018.

Commissioner's Speech:

Remarks by Dr. Gottlieb at the Workshop "Packaging, Storage, and Disposal Options to Enhance Opioid Safety - Exploring the Path Forward"

Commissioner’s Statement:

Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal

For Further Information Contact:

Scientific Contact:
Irene Z. Chan, PharmD
Food and Drug Administration
10903 New Hampshire Avenue
Building 22, Room 4420
Silver Spring, MD 20993-0002
Tel: 301-796-3962
Email: Irene.Chan2@fda.hhs.gov

Logistics Contact:
Michelle Eby, PharmD
Food and Drug Administration
10903 New Hampshire Avenue
Building 22, Room 4422
Silver Spring, MD 20993-0002
Tel: 301-796-4714
Email: Michelle.Eby@fda.hhs.gov

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