Building & Maintaining a Relationship with Regulatory Authorities

(or any Regulatory Agency for that matter!)

I once learned from a very awesome colleague of mine (not to mention any names, but Michael Katz of Blue Penguin Development, small business marketing guru!), to “Stay in front of the people you know, over and over again, in a way that positions you as a likeable expert.” Not only does this apply to businesses marketing their products or services, but it also applies to pharma/biotech/medical device companies who are trying to build and maintain a relationship with the FDA (or any other Regulatory Agency)!

11Have you ever found yourself scared/nervous or intimidated to talk to someone?

I think we all have! I can remember numerous times during my school years and/or my early professional career. And even to this day! Sweaty palms…is this person smarter than me, am I going to say something stupid, are they going to ask me something I don’t know, are they going to believe me? We’re all human and whether we admit it, it’s something that happens to us all!

Similarly, most (or all!) pharma/biotech/medical device companies go through this regularly when it’s time to approach the FDA! Why? Because the FDA is very POWERFUL in our industry…they have the power to decide if the (on average) 7-10 years of research and millions of dollars we have spent in developing our drugs/biologics/medical devices will be time and money well spent. They decide if our products are approved for market! YIKES! That is intimidating! BUT…guess what…although they have a big, scary name, the Food and Drug Administration, the Agency is made up of all HUMANS! People! Just like us! With emotions! Crazy right?!?!

Just like pets do, the FDA will sense when you are scared/intimidated and it will come off as a lack of confidence in your product. Am I saying don’t be nervous?!?! NO…being a bit nervous is not a bad thing. It shows that you CARE and it shows that you’re HUMAN. It’s like a job interview…if I interview consultants for my company that don’t seem at all nervous, I question whether or not they truly care about the opportunity. I may also view them as overly-confident…which isn’t usually a good thing in a professional setting (or anywhere for that matter).

So…we’ve established that the FDA and other regulatory agencies can be intimidating…and that we all probably feel like high school students before taking a final exam, when having to approach them! So, how do we build a strong relationship and maintain a positive and comfortable partnership with them?

  • Remember that they are human too! They get happy, sad, nervous, scared, intimidated, frustrated and excited also! Try not to focus on the “power” that they have. We all have a common goal…to prolong life and improve quality of life for patients’ suffering from medical conditions. Therefore, think of your company’s relationship with the FDA as a COLLABORATION.
  • Start your communications with the Agency early on in your program! If you initiate communication with them from the get-go and build a friendly relationship/partnership from the start, you will eliminate the intimidation factor and the process will be much smoother, efficient and less stressful! (in short, it’ll have the same effect on you as a Dunkin Donuts coffee! Well, ok, for me at least!)
  • Maintain consistent communication! Build a long-lasting relationship with the assigned Project Manager and Division Director! They work with a ton of people/companies and have their brains on overload with multiple programs. You can be forgotten! SO…don’t let them forget you! Find reasons to stay in touch (e.g. may seem simple, but send them an email notification when you’ve submitted a submission—to assure they receive it and…to keep in touch!)!

Ask questions, get their input (beware, don’t treat this lightly, there are do’s and don’ts when it comes to asking the FDA questions! See below in Toto’s Tips!).

Building this relationship early on and maintaining the communication will save your company a lot of time, frustration and money. If you “avoid” the FDA and decide to “guess” the proper studies and development path for your product, you may find out that you wasted a lot of time and money doing studies that weren’t needed. OR…you may miss a crucial step along the way and have to go back and start from scratch! All ending in a huge loss of time and money…nothing anyone wants!

Toto's Tips

The Do’s and Don’ts when asking the FDA questions!

  • Be specific and non-open ended: You want to walk away with a clear path forward; ambiguous questions won’t get you there!
  • Support with data/info: Be sure to know all of the possible answers, so there are no surprises; research first if needed.
  • Seek agreement: “Do you agree?” (shows confidence, avoids open-end)
  • Direct questions are OK for critical decisions: No gray areas, you need the facts/answer; Yes or No questions help; Ask these questions early!
  • Ask a lot early on in your products lifecycle
    • Make sure the agency is on the same page in regards to indication and labeling; there should be no ambiguity here; “Do you agree with our proposed…”
  • Be positive and confident when posing your questions (in writing and face-to-face).
  • Ask the most critical/important questions first, in case time runs out.
  • If you know the answer, don’t ask the question! Your time with the FDA is precious, so use it wisely!
  • Never put the FDA on the spot: Don’t make them feel cornered; remember, you want to be friends and have a comfortable relationship! Oh—and unlike you do to your spouse, never tell them they’re wrong. 😉