Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products

The FDA is holding a public meeting to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties. The meeting is intended to give FDA the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The meeting will also provide an opportunity to discuss FDA’s efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. FDA is seeking input from all stakeholders, including patients, health care providers, health care payers, the pharmaceutical industry, patient advocates, academics, researchers, and other government entities.

Advance registration for the meeting closed October 26, 2016. Space permitting, in-person registration is available at the meeting location on the days of the meeting, October 31 and November 1, 2016. Online registration for the webcast is also available on those dates, capacity permitting. Please use this link for webcast registration: http://www.cvent.com/d/wvq0sm/

In order to permit the widest possible opportunity for public comment, FDA has also opened a docket. Electronic or written comments regarding scientific and technical issues relating to formulation development and pre-market evaluation of abuse-deterrent properties of opioid drug products may be submitted to docket number FDA-2016-N-2896. The deadline for submitting comments is January 3, 2017.

Dates and Times:

• October 31, 2016 – 8:30 a.m. to 4:30 p.m.
• November 1, 2016 – 8:30 a.m. to 4:00 p.m.

Note: The meeting may be extended or end early depending on the level of public participation.

Location:

College Park Marriott Hotel and Conference Center
3501 University Blvd. East
Hyattsville, MD 20783

Webcast Information:

• Day 1, 10/31/2016
• Day 2, 11/1/2016

Transcripts

The transcripts of the public workshop are available below:

• Transcript: Monday, October 31, 2016 (PDF - 940 KB)
• Transcript: Tuesday, November 1, 2016 (PDF - 636 KB)

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Meeting Materials

• Federal Register Notice
• Agenda
• Open Session Speakers for Day 1 of 2016 Generic AD Opioids Public Meeting
• Open Session Speakers for Day 2 of 2016 Generic AD Opioids Public Meeting
• Transcript of August 19, 2016 Telecon with Brand Name Industry
• Transcript of August 19, 2016 Telecon with Generics Industry
• General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry

Presentations: Day 1

• Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products – Framing the Meeting
• Introduction to FDA’s draft guidance on the General Principles for Evaluation of Abuse Deterrence of Generic Solid Oral Opioid Drug Products
• Foundations of In Vitro Comparisons of Generic Opioids to Reference Listed Drugs (RLDs) with Labeling Describing Abuse-deterrent (AD) Properties: FDA’s Research Effort
• ADF Meeting Day 1
• Abuse Deterrent Opiod Formulations, Good, C.B.
• Branded Industry Perspective on the Generics ADF Guidance
• Foundations of Pharmacokinetic Comparisons of Generic Opioids to RLDs with Labeling Describing Abuse-Deterrent Properties, Zhao, Liang
• Recommendations from the Generic Industry Working Group for Comments on the Draft Guidance on General Principles for Development of Generic of Abuse-Deterrent Opioid Formulations, Levin, P
• Foundations of in vitro comparisons of generic opioids to reference listed drugs (RDLs) with labeling describing abuse-deterrent propertiesPublic Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products, Hoag, S.
• Abuse-Deterrent Formulations: A Private Payer View, FDA Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products
• The Importance of Measuring Real World Abuse Deterrence of Generic Opioids: In Vitro and HAL Data are not Enough

Presentations: Day 2

• Abuse Deterrent Formula_Buhse
• Vision for Standardizing In Vitro Testing to Evaluate Abuse Deterrence of Opioid Products
• ADF Meeting Day 2 Slides with Questions for Panel
• ADF has an Impact in Abuse_Kraus, A
• Standardizing In Vitro Testing, Fleming, Alison
• PMRxS, Thompson, Edwin
• Recommendations from the Generic Industry Working Group for Comments on the Draft Guidance on General Principles for Development of Generic of Abuse-Deterrent Opioid Formulations, Kovacs, Elisabeth
• Gatekeeper, Innovations, Inc. Medicine Safekeeping for Good Health Langley, Nathan