In recent blog posts we have analyzed recent U.S. Food and Drug Administration (FDA) guidance topics regarding formal meetings with the FDA and best practices for communicating with FDA during drug development. One topic which we have not addressed is just how to ask questions of regulators. Consider the situation: you want to request a meeting with the Agency. You need to sit down with regulators face to face to discuss your firm’s drug development program. In order to submit a meeting request, you need to provide a list of questions you would like FDA feedback on.
Questions to avoid asking FDA
You may be tempted to pose one of the following questions: “If we commit to run the clinical trial in this way, will you give us the go-ahead to start it?” “If we have 12 months of stability data, will you grant a 24-month shelf life?” “If we submit the result of two clinical trials, with a total of this number of patients, will you approve the drug?”
The likely FDA answer to each of the above questions and, indeed, to any questions that are framed like them, is going to be, “That is a review issue. Next question.” Why is this? FDA reviewers do not want to review large data sets twice: once to answer your question in the meeting, and then a second time when the actual submission comes in. There is a better way; a lesson I learned during a very awkward meeting with regulators from a Latin American nation.
Meeting with regulatory agencies: Set appropriate expectations
I was asked to meet with regulators in this country by a previous employer to address some issues. What I did not realize is that the person in the regulatory agency who agreed to the meeting was out sick, nor was I aware that the dozen or so regulators were notified that my firm was bringing this ex-FDA guy (me) to tell them how things should be done. Yikes!
So, there I sat, with stony faces glaring at me. I swallowed hard and asked my colleague who was serving as my translator to tell the assembled regulators that I was there to learn what they needed to make a good public health decision for the citizens of their country. Upon hearing my question, I noticed relaxed expressions and smiles as I looked around the table. By posing that question first, I was able to enter into a productive discussion about the kind of data that they were looking for in order to decide on the shelf life of my company’s product (the issue that I had been brought in to support). Once we agreed on the necessary data, I was able to show them that our submission included that specific information and the problem was resolved.
Asking FDA the right questions
The simple lesson learned was this: if you frame a question to regulators in terms of “Will you approve this?” you are likely to receive a non-answer (i.e. “That’s a review issue”). If, instead you frame the question differently, (i.e. “Here is the protocol we will use to get the data, will that give you the information that you need to make a good decision?”), you set the table for an effective back and forth about your research plans. You cannot get regulators to review and approve a data set in a meeting, but you can get them to agree that your plans to generate data are good. And this is exactly what you need as you develop your product.
Need help talking to FDA? Pearl Pathways knows how to ask the right questions and the right way to get answers to help speed your drug, device, or diagnostic to patients. Contact our experts today.
Related posts in this blog series:
- What is an FDA guidance document?
- Formal meetings with FDA for drug developers
- Best practices for communication between IND Sponsors and FDA during drug development