Public meeting for patient-focused drug development on opioid use disorder (OUD)

On April 17, 2018, FDA is hosting a public meeting on Patient-Focused Drug Development for Opioid Use Disorder (OUD), in collaboration with National Institute of Drug Abuse (NIDA). In addition to NIDA, FDA is also working closely with patient advocacy and community organizations to encourage participation from persons with OUD. This meeting aligns with FDA’s ongoing work aimed at reducing the impact of opioid abuse and addiction.

FDA is interested in learning patients’ perspectives on OUD, including the effects on their health and well-being that have the greatest impact on daily life, their experience using prescription medical treatments and other treatments or therapies for OUD, and challenges or barriers to accessing or using medical treatments for OUD.

The questions that will be asked of individuals with OUD at the meeting are listed below, organized by topic. For each topic, a brief initial panel of individuals with OUD and/or persons’ representing individuals with OUD will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other participants in the audience. Webcast participants will also have an opportunity to provide input through webcast comments.

If you are attending the meeting in person and are interested in providing comments as part of the initial panel discussion on April 17th, indicate so during the registration process. Potential panelists must send a brief summary of responses to the discussion questions below by April 4th to PatientFocused@fda.hhs.gov . Panelists will be confirmed prior to the meeting.

Meeting participants may remain anonymous during registration, when submitting summary responses, and during the meeting. Contact information provided during registration will remain confidential and only used to send meeting updates and information to participants. You may enter anonymous in the first and last name field for contact information during registration.

There will also be an opportunity for individuals with OUD, representatives/advocates and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign-up for Open Public Comment will occur on-site during the day of the meeting.

For more information, please visit the FDA meeting website:

http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm591290.htm