The first day of the Food and Drug Law Institute’s Annual Conference started with an excellent keynote address from FDA Commissioner Dr. Robert Califf, who underscored the importance of the FDA engaging with industry to evaluate the promise (as well as risks) of new technology and medicinal products.  Part of that dialogue happens at the individual application or facility level, but what happens when you are not hearing back from the FDA and the dialogue feels very one‑sided…?

The afternoon breakout session titled “Interacting with FDA: Navigating Challenges and Making the Most of Opportunities to Engage the Agency” provided a lot of answers to that question.  The panel was made up of current and former FDA staff who work currently (or worked previously) as Ombudsman in various Offices throughout the Agency.  They offered a unique perspective on Agency interactions, especially those former staffers who have since moved into private practice or industry.  The importance of getting to know and fostering good communication with your Regulatory Project Managers (RPMs) was reinforced.  Your RPMs are your main point of contact and, if you nurture the relationship when things are going well, this will work in your favor if things go wrong.  Of course, we hope they never go wrong, but we need to be realistic!  Jessica Zeller, current Vice Present of Quality, Regulatory & Public Affairs Counsel at Edwards Lifesciences, summed it up well with her comment that it is really hard to make friends during a crisis.

Reaching out and working with the FDA to address questions early and before they become a crisis is good advice, but what if you are not hearing back or don’t know who to turn to?  This is where the Ombudsman can help.  You can review the FDA org chart to find the chain of command for your RPM to escalate the issue yourself, but you can also find the Ombudsman in your product center or contact the Office of the Ombudsman directly, and they can help.  Some common scenarios where you may want to give your Ombudsman a ring or send an email are as follows:

  • You are stuck between calling your RPM or the local ORA office because you are not sure whether it is an application or a facility/inspection question. They can guide you.
  • You have followed up with your RPM but are not getting a response to acknowledge your communication.
  • You need assistance following up after an inspection if you haven’t seen your EIR.

The Ombudsman can even help you figure out where to direct your question if you are unsure of where to start; they know the Agency and can help direct questions on guidance or policy, but their main role is to act as liaison to keep the FDA and industry communicating, and to be the grease between the wheels of communication and progress.

A key takeaway from this session was that you should be an active stakeholder and advocate for your products and your facility.  New and emerging technology can create knowledge gaps and raise new questions for the FDA so sometimes patience is needed as there may be a steep learning curve involved.  When reaching out via phone, always state who you are and how to reach you, then discuss your question or issue.  A long narrative will get cut off by the voicemail system so you may not get a chance to tell your full story or leave your contact info if you wait until the end.  If you record your name and contact info first, they can follow up if the full question was not captured in your voicemail.  Always come with a plan.  Open‑ended questions are hard but if you state the issue or question and propose a solution, it is much easier for the FDA to respond quickly so you may be more likely to get a response.

The bottom line is that we are all in this together.  The FDA’s role is to make science-based decisions in the interest of public health, and it is there to help us get products to market.  It is always good to interact with Agency staff at meetings so that you and the FDA can put faces to names and make new connections.  However, it can be equally important to create relationships that perhaps can help your question get to the right person at the right time (to avoid a bigger issue) so we can work together to support getting products on the market and to patients.