The Office of Orphan Products Development (OOPD) issued a draft guidance on policies and procedures for meetings with stakeholders. The primary intent of the guidance is to provide structure around formal meetings that occur with this group. While the vast majority of questions from stakeholders can be handled through informal ad hoc teleconferences or e-mails, OOPD has found that discussions of critical issues such as designation request deficiency letters and denials, orphan exclusivity, and some other topics require a larger group of participants and more complex issues than can be readily dealt with on an ad hoc basis.
The new guidance takes many cues from the guidance on formal PDUFA meetings but with a lower degree of formality. For example for formal OOPD meetings:
|Meeting Requests||Submitted via e-mail either to the general OOPD inbox or to the identified point
of contact for a specific designation request
|Response to Meeting
|Within 5 business days|
|Briefing Package||Due at least 2 weeks before the meeting. Includes meeting basics (date, time,
subject, purpose, attendees), a detailed list of questions for OOPD, and sufficient
background information to help OOPD answer the questions
|Meeting Procedures||-Chaired by OOPD
-Opened with introductions and statement of the meeting purpose
-Presentations allowed; brevity is encouraged to allow for discussion
-Presentation of new information (i.e., not in briefing package) discouraged
-Meeting ends with closing summary comments and recap of action items
|Meeting Minutes||Draft prepared by stakeholder and submitted via e-mail to OOPD within
3 weeks of the meeting. Draft is reviewed and edited by OOPD and returned
to stakeholder via e-mail within an additional 3 weeks. The stakeholder
either accepts this draft, or submits revisions for another round of review
These meetings also differ from PDUFA meetings in that they are not intended to serve as pre-submission meetings. OOPD does not intend to grant meetings to discuss the sufficiency of the intended content of future designation or grant requests or to provide input on development plans or protocols.
Carrie Rabe is a Senior Consultant at The Weinberg Group, the world’s leading food and drug consulting firm. Learn more about The Weinberg Group’s expertise and consulting services for orphan drug products. If you have any questions or thoughts on this blog post or others, please reach out to us by email.