By Ray Tobey, Chief Medical Officer on Dec 13, 2017 9:00:00 AM
Each biotech company has a different culture, communication style, set of preferences, and documentation needs, so there is essentially no single best communication method between the FDA and your IND sponsor. However, there are best practices to optimize interactions between the two entities during the drug development process to help minimize wasteful expenditures of time and resources.
Your sponsor’s primary point of contact for communication with the FDA is the Regulatory Project Manager (RPM) who will not be on the review committee for your IND submission. Reviewers are strongly discouraged from having direct communications with sponsors as it is not considered a best practice and could lead to a conflict of interest. Therefore, the role of the RPM is to facilitate timely resolutions of technical, scientific and regulatory questions, conflict or communication challenges.
To help facilitate ease of interaction between the RPM and IND sponsor, here are some common understandings that both should have. For a more comprehensive version, please click here.
IND sponsor best practices:
- Review information available online before requesting a meeting.
- Request milestone meetings including; Pre-IND, End-of-Phase 1, End-of-Phase 2, and Pre-NDA/BL.
- Do not ask questions during the meeting that were not included in the meeting package.
- Do not present new data or information during the meeting.
- Limit questions to what can be reasonably discussed within the duration of allotted meeting time.
RPM best practices:
- Sponsor inquiries should be acknowledged within 3 business days of receipt by the RPM.
- Ensure Pre-IND and Pre-NDA/BL meetings include a discussion of what constitutes a complete application.
- The communication should be based on processes, not providing review information that may not accurately or comprehensively capture the FDA’s thinking.
A communication problem we see a lot of is discreet yet can lead to varying interpretations of next steps and have a big impact. Specifically, changing one word can shift a conversation from, ‘you must do this’ vs. ‘it may be a good idea’. Here are some terms and phrases that both parties should understand and use appropriately and consistently:
- Use words such as shall, must and required to convey a regulatory requirement.
- Use the following to communicate advice (i.e. on trial design) comments, or critical thinking: advisable, discourage, recommend, critical, encourage, may be appropriate, important, prefer, should, suggest, consider and urge.
For a secondary point of contact for sponsors who are encountering problems with their RPA, you can contact the FDAs Enhanced Communication Team at ONDEnhancedComm@fda.hhs.gov or call 301-796-0319.
Did we miss any tips that you find helpful? We’d love to hear about them, please comment below.