13 Tips for Successful FDA Meetings

There are many reasons for meeting with the FDA during development of a regenerative medicine product. Some regenerative medicine products are more novel than others, meaning they are so unique they have never been studied in human clinical trials. Others may not be first of its kind, but may be used in novel clinical applications or be manufactured in new ways in comparison to competitor products. The nuts and bolts of preparing to meet with the FDA will be covered in a separate posting.

There are a number of opportunities for informal and formal communications with the FDA. For the purpose of this post, I am assuming you have requested a formal meeting with the FDA, perhaps to discuss the filing of an investigational new drug (IND) application to initiate human clinical studies.

Usually, to reach this point you will have expended a significant amounts of time and money. Therefore you don’t want to blow it by not being prepared to meet effectively with the FDA. Below is my list of tips to help the process go more smoothly:

  1. Remember, The FDA Wants You to Succeed
  2. Leave the “Dog & Pony” Show at Home
  3. Safety is the FDA’s Primary Focus
  4. Provide Clarification for FDA Identified Issues
  5. The FDA Will Have Questions, Lots of Them
  6. Designate a Spokesperson to Lead the Discussion
  7. Unity is a Virtue
  8. Take Time to Summarize
  9. Call in Early
  10. Call a “Time Out” if Needed
  11. Identify yourself
  12. You May Get the FDA’s Comments Early
  13. Overall, Remain Calm, Be Factual and Enjoy the Experience.

Read on, for my thoughts on how each of these tips can be used to ensure a smooth meeting with the FDA.

Remember, The FDA Wants You to Succeed

Keep foremost in your mind that the FDA is trying to be helpful and is interested in seeing therapies reach the clinic. They have a mandate to both protect and promote the Public Health. There are specific standards that must be met to address regulatory concerns, but they are willing to discuss with you how to successfully address those concerns in order for your regenerative medicine product to be tested in the clinic.

Many regenerative medicine products are unique and are targeted toward meeting unmet medical needs. Consequently, seeing those unmet medical needs addressed by a new medical intervention is a mutually shared interest between you and the FDA.

Leave the “Dog & Pony” Show at Home

The FDA will have read the briefing document and will have discussed issues internally before the meeting or call. Consequently, unless they specifically request you provide an introductory slide presentation, don’t do it. It is literally a waste of your time, since the FDA will have a hard stop at the end of the allotted meeting time.

The FDA staff usually have back to back meetings, so they will be dashing off as soon as your time is up. A corporate “dog and pony” show extolling the wondrous virtues of your product just annoys the FDA. Save it for your investors.

Safety is the FDA’s Primary Focus

  • Do not debate issues of safety (real or imagined) with the FDA.

o Listen carefully

o Ask for clarification if need be

o Agree when possible

  • It is essential that the you demonstrate that the clinical development program is safety oriented and that due care and thought had gone into preparing your clinical, non-clinical and manufacturing plans

Provide Clarification for FDA Identified Issues

If is OK to provide clarification when needed, but if it is clear the FDA is not budging on an issue that you disagree with, simply request to revisit the issue with the FDA sometime after the phone call, so the appropriate facts can be brought together.

The FDA Will Have Questions, Lots of Them

  • Let the FDA Reviewer finish and listen carefully before responding, ask for clarification if you do not fully understand the question.
  • If you don’t have an immediate answer to the question, it is OK. Note the issue and move on.
  • If you do have a response, keep it short and to the point.
    • The FDA is data driven; stick to the facts.

o Most people have a tendency to go overboard in their enthusiasm to share their knowledge and consequently go on and on….STOP, do not do this! It annoys the FDA and often results in the response being a mixture of facts and conjecture, which is a not good.

Designate a Spokesperson to Lead the Discussion

It usually works best if only one or two people from the meeting team lead the discussion. As questions or issues arise these designated spokespersons can request input from specific individuals to minimize talking over one another.

Unity is a Virtue

Obviously, do not argue with one another when on the phone or during the meeting with the FDA. Areas of disagreement can be discussed in the de-brief after the meeting.

Take Time to Summarize

In the last 5-10 minutes of the allotted meeting time, attempt to summarize the conversation with the FDA to ensure what you heard and understood is the same as the FDA. Also, identify action items requiring further follow up and who at the FDA should be contacted regarding any outstanding issues

Be sure to have your own scribe taking detailed minutes of the meeting

Logistical Considerations

Call in Early

For conference calls with the FDA, all participants should dial into the conference line at least 5-10 minutes in advance to ensure there are no delays when the FDA comes on the line.

Call a “Time Out” if Needed

If during a conference call with the FDA an unexpected issues is raised you can ask the FDA for a 1- 2 minute ‘break’ and put the phone on mute and have a quick internal discussion to reach consensus, which obviously only works for those in the room.

Identify yourself

For telephone conference calls, for those who speak, be sure and identify yourself each time you respond.

You May Get the FDA’s Comments Early

For many meetings the FDA will FAX draft comments in advance of the meeting. This is not required of the FDA, but when it does occur, it usually allows for a much more productive meeting, focusing on the FDA identified issues. Consequently, it is important that someone in your home office be available late in the day to receive the FAX and relay them to meeting team so they can be read and appropriate responses formulated.

Overall, Remain Calm, Be Factual and Enjoy the Experience.

I routinely send these tips to all participants in advance of a meeting with the FDA as a ‘refresher’ and to help set a positive tone for the interaction.

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