Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities

The purpose of the public workshop is to host a scientific discussion with expert panel members and interested stakeholders about the challenges in using the currently available data and methods for assessing the impact of opioid formulations with abuse-deterrent properties on opioid misuse, abuse, addiction, overdose, and death in the postmarket setting. The goal of this meeting is to discuss ways to improve the analysis and interpretation of existing data, as well as to discuss opportunities and challenges for collecting and/or linking additional data to improve national surveillance and research capabilities in this area.

Date:

July 10, 2017 from 8:30 a.m. to 5:00 p.m.
July 11, 2017 from 8:30 a.m. to 5:00 p.m.

Location:

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

Meeting Materials

• Meeting Agenda (PDF - 39KB)
• Federal Register Notice
• Issues Paper (PDF - 210KB)
• List of FDA Participants (PDF - 13KB)
• List of Panelists (PDF - 20KB)
• Panelist Bios (PDF - 92KB)
• Disclosure Forms (PDF - 3.59MB)

Presentations

• Dr. Gottlieb's Remarks Delivered Before FDA’s Scientific Meeting on Opioids
• Overview of Public Meeting & Day 1 Roadmap (PDF - 448KB)
  Judy Staffa, Ph.D., R.Ph.
• Current Data Resources Used to Investigate Drug Products with Properties Intended to Deter Abuse (PDF - 239KB)
  Cynthia Kornegay, Ph.D.
• Sampling, Metrics, and Denominators (PDF - 345KB)
  Kunthel By, Ph.D.
• Causal Inference and Control for Confounding (PDF - 169KB)
  Jana McAninch, MD, MPH, MS
• Day 2 Roadmap (PDF - 214KB)
  Mark Levenson, Ph.D.
• National Surveys: Opportunities for Evaluation of ADFs (PDF - 295KB)
  Jana McAninch, MD, MPH, MS
• Designs That Assess Exposure and Outcome in the Same Individuals Over Time (PDF - 712KB)
  Tamra Meyer, PhD, MPH
• Leveraging other data: Linking and benchmarking (PDF - 207KB)
  Cynthia Kornegay, Ph.D.

Webcast of the Public Workshop:

The archived webcast of the public workshop is available on the link below.

Archived Webcast 

Transcripts:

The transcripts of the public workshop are now available below, and accessible online at https://www.regulations.gov/searchResults?rpp=25&po=0&s=FDA-2017-N-2903&fp=true&ns=true.

It may be viewed at the Division of Dockets Management.

• Transcript: Monday, July 10, 2017 (PDF - 1MB)
• Transcript: Tuesday, July 11, 2017 (PDF - 891KB)

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

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 September 11, 2017.

For further information contact:

Scientific Contact:
Cynthia Kornegay
Food and Drug Administration
10903 New Hampshire Avenue
Building 22, Room 2456, Silver Spring, MD, 20993-0002
Tel: 301-796-0187, Email: Cynthia.Kornegay@fda.hhs.gov

Logistics Contact:
Cherice Holloway
Food and Drug Administration
10903 New Hampshire Avenue
Building 22, Room 4466, Silver Spring, MD, 20993-0002
Tel: 301-796-4909, Email: Cherice.Holloway@fda.hhs.gov