Health Law Diagnosed – Best Practices for Communicating with the FDA

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA.

Hear from Joanne Hawana and Ben Zegarelli, FDA specialists in the Health Practice at Mintz, and John Daley, VP SME at Compliance Architects, as they share war stories and offer advice for navigating communications with the FDA.

Have questions or want to connect with the team? Reach out to us at [email protected] .

Health Law Diagnosed – Best Practices for Communicating with the FDA - Transcript

Bridgette Keller (BK): Hi there, welcome back to Health Law Diagnosed, a Mintz podcast dedicated to health law, health policy, and social issues in the healthcare industry. I’m Bridgette Keller, your podcast host. Today we are going to be discussing best practices in interacting and communicating with the FDA. I am so excited to be joined by several experts who often navigate these communications. We’ll have my colleagues, Joanne Hawana and Ben Zegarelli, our FDA specialists in the health section here at Mintz, and John Daley, VP SME at Compliance Architects. Joanne, Ben, John, thank you so much for joining us today.

I would love to start off by having everyone introduce yourselves and talk a little bit about your expertise and background, and why you know so much about communicating with the FDA.

John Daley (JD): Thank you, Bridgette. This is John. I’ve been in FDA regulated industry for approximately 40 years. And throughout that time, initially by what I thought was bad luck, but ended up being good luck, I ended up with some troubled companies. I would come into companies after they’d gotten in trouble, but I’d get to both see the aftermath and see how they handled it.

As I grew in my career, I had higher positions, so I actually got to get farther and farther behind the curtain, as it were. I’ve gotten a lot of experience in crafting responses, both benign responses all the way up to probation agreements. Then recently, I went into consulting with Compliance Architects. We’re a firm that handles all forms of FDA-related matters. Obviously, you end up doing a lot of remediation work, although you’d love to be brought in before you end up with a lot of remediation work. That has helped me put to use all that I’ve learned in my industry experience with communicating with the agency. I’m looking forward to talking about some of those hard-won lessons.

BK: Thanks so much. I’m sure you have a lot of war stories to share with us from over the years.

JD: We don’t have time for me to go through all of them. I’ll try and pick some of the better ones.

BK: Perfect. Joanne, do you want to do a quick introduction? I know you’ve met our listeners before, but it would be great to have a quick refresher.

Joanne Hawana (JH): Absolutely. Thanks, Bridgette, for having us today. This is Joanne Hawana. As you said, I’m an FDA regulatory and compliance lawyer here at Mintz. We got to meet John through, as he mentioned in his intro, a remediation-type project for a shared client. And what we do here at Mintz often is ensure that when our clients are communicating with FDA, whether it’s normal course type activities or in the context of a recall or an inspection or a warning letter, that everything is very clear and doesn’t create new questions or new lines of inquiry from the agency. I think the impetus for this discussion was really our shared belief that communication is a key component of any sort of strategy that you’re executing or activity that you’re doing involving a government agency, whether it’s FDA or another one.

I’m really excited to have this conversation today, and thanks again for hosting us.

Ben Zegarelli (BZ): Yeah. And this is Ben. I’ll just echo what Joanne was saying. I’m also a regulatory compliance attorney here at Mintz, with a number of past experiences communicating with the agency in various capacities in different situations — some more exigent than others. We often coordinate with consultants like John and compliance architects to build out our capabilities in these cases where we’re responding to the agency and it takes more resources than what we can put together just as a law firm. But, really help engage those regulatory professionals for clients to really maximize that benefit and those responses to the agency to make sure we’re covering everything we need to cover. Like Joanne and John said, I’m excited to be here today and to talk through this and lay some of the groundwork for some of these best practices.

BK: Wonderful. I’m excited to jump right in here. As an initial matter, I was wondering if you all could describe the scope of our topic today. Communications with the FDA sounds pretty expansive. So I’m thinking, what types of companies are we talking about? And what kinds of communications with the agency?

JD: Well, Bridgette, I would say we’re talking any regulated company, large or small, because they’re all regulated equally. So they’ll all have interaction in some way, shape, or form. Then I’d break it down into two paths. One, benign interactions, things like routine requests from FDA, a presubmission meeting, clarifications — and then what we’ll call nonbenign interactions. So you’ve gotten 483 observations — that’s not benign, but probably the lowest level. And then it escalates. Maybe you’ve gotten a warning letter, and then you’ve gone beyond warning letter to a consent decree, a probation agreement, a deferred prosecution agreement. There are certain things you want in all three of those. And certain elements become far more important as you go up that scale of nonbenignness, whatever the proper word is for that. I’ll look to my legal friends to get me the proper word.

BZ: We should say that John’s spot on. We’re talking about all companies, firms that will be regulated by FDA. And while the specific types or circumstances of these communications may vary among the centers and divisions at FDA, they typically all fall in those same types of buckets that John just mentioned.

It’s important to remember that when we’re talking about best practices here, they apply across the board. You’re still communicating with agency officials, no matter what the context is. So we’re going to be talking about those general practices that you really want to keep in mind when you’re constructing these communications — whether it’s in a meeting, when you’re talking face to face or virtually or in person, or whether you’re submitting something in writing, the best practices are all essentially the same across the board.

JD: I would say the trifecta for all communications would be: try and be clear, be respectful, and be responsive. We can talk about what each of those means in the context of different responses. If you’re meeting those three objectives in all your communications, you’re building trust and you’re getting better with every interaction.

BK: John, I feel like that’s good advice for all communications, not even just with the FDA, right?

JD: Absolutely, but it’s often observed in the breach, right?

BK: Of course. So how does a company typically communicate with FDA, and who’s involved in those communications? The reason I’m thinking of this is, in my practice we often communicate with CMS and there’s a variety of different ways to communicate with the various regulators there and mechanisms to do that. So how does it work with FDA?

JD: There are two main communication conduits. The people who routinely interact the most would be the folks in regulatory affairs, in either device or pharmaceutical or cosmetics companies. They’re the folks who are doing the filings, getting the questions back, and then farming those out for clarification. They should be very well versed in communicating, figuring out what the agency is asking and getting back to them.

The other mode is generally when, as we mentioned, you end up in some sort of issue, whether it’s a 483 observation or worse. Then quality generally takes the lead on those responses because usually those observations are coming from failures in quality systems. Not so much submission failures (that can happen), but it’s usually due to an inspection or a recall or some other precipitating incident that has brought you to the agency’s attention. That’s where being clear, respectful, responsive becomes so much more critical when you’re responding to a 483 especially.

Usually that’s the escalation, right? It starts with 483, and then it becomes a warning letter, and then it can escalate further — although all those can be short-circuited, depending upon what you’re talking about. You need to make sure you’re keeping these in mind throughout all those interactions.

JH: Some communications will be written and they may be formal type submissions. For example, John mentioned a presubmission meeting in the device context — you would make a presubmission request and a package of information that supports that interaction that you’re going to have with the agency.

Some communications will be verbal. You’ll have a face-to-face meeting, an in-person meeting. Again, these best practices we’re talking about are applicable irrespective of the forum of that communication that you’re having. Even in a real-life meeting, you want to be respectful and clear and factually accurate. Of course, John mentioned fact checking and farming out responses. In any government communication, we always want to make sure everything is factually accurate or properly qualified and disclosed if we’re limiting what we’re responding to. But we can have paper, verbal, email sometimes. Ben and I had an example where a client ended up in a bit of a pickle due to some email responses that they sent back to an FDA investigator without necessarily realizing that that email communication was essentially the beginning of an investigation. They didn’t respond in the best way.

So we can talk more about that example, but I just wanted to mention that there are multiple venues for these communications we’re talking about.

BZ: We can’t forget the lawyer’s role in communications. I certainly agree with everything that John and Joanne just said. I’ll add as an additional layer that in many of these cases of communications with FDA, lawyers are typically involved either as just the final check to make sure that things are in order and that nothing could present any sort of liability down the road or any other legal issues. For most cases — regulatory affairs, quality — they’re going to run the show with most communications with the agency because of their subject matter expertise. This is for a number of reasons. For something like a quality issue, you want the qualified quality engineers to be able to describe the problems appropriately because they will be able to communicate most effectively with their counterparts at FDA who will be interpreting what they’re saying. Same thing goes with regulatory affairs. In many cases, the regulatory affairs personnel at a company will understand the applicable procedures and other matters that are internal and are best able to describe those to the agency. In many cases, they know how to do that effectively and in a way that’s going to convey the willingness of the company to comply with their own procedures as well as the agency’s regulations. In some cases though, especially when things are a little bit more sensitive, like in inspectional observation response or a warning letter response or something that’s even more sensitive — like if there’s any sort of potential prosecutorial involvement or if there’s a threatened seizure or potentially some more enforcement action–related issues — attorneys are usually involved to closely coordinate with regulatory affairs and also quality assurance to run through everything and make sure everything is consistent, so you know that there’s no liability issues or minimizing any potential effects.

JD: I personally don’t like the situations that have me working with lawyers, but I love the help that lawyers give because you’re very similar to quality folks. You are so well trained in presenting things logically, ensuring that references are appropriate and checked and structured. It’s usually a huge help and another set of eyes. And of course, looking out for gotchas that may be there.

Starting on the war stories. Joanne and I were involved with a client and there was some questions on some other legal matters. There was a whole other legal firm working on that. But we were looking at the compliance issues — all your listeners may not know, but the FDA requires that regulated companies maintain complaint handling systems in postmarket. It’s called postmarket surveillance. It’s a federal requirement; it’s a global requirement. All the regulatory agencies across the world require it. However, in that, you get complaints like “Hey, my device exploded.” It ranges from that. We’re on with these criminal folks, and we talk about how we have received a complaint of a very serious injury. So we’re going to report this to the FDA. And I saw his eyes light up, and I said, “Wait, it’s in our statutes that that is not an admission of guilt.” He said, “Well, John, thank God, because that’s where I was going next.” I said, “No, that’s just the allegation.” But again, that’s the clear communication. As they said, it’s factual. We need to do it. And I do want to talk about the respectful nature of the communications with the FDA.

One thing I would say to anyone who’s listening, whoever thinks like the FDA was out to get me or you have people in your firm who feel that way, put that aside. They’re not out to get anyone. They’re out to protect public health. It is their mission and they take it seriously. So if they’re asking for things, if they’ve given you an observation, it’s because they believe you’ve done something that you shouldn’t. What I’m ultimately saying is, if you’re responding to their observations, do it in a respectful manner. Repeat it back so they know you got it. Take ownership of the issue. If there is something factually incorrect, you can make the case. Usually, however, it’s factually incorrect because during the audit or in a prior submission you made, you put something wrong in there. Own that, if that’s the case.

And then, the other keys for all of these: provide specific corrective actions that you’re going to do, put time-bound actions and commit to updates. The responsive part is not just responding to them, but committing to updates — and make the updates on time. If you’ve got a complicated issue, I guarantee you some of those things will take longer than you thought. That’s scary, you don’t want to admit that, but come clean as soon as you know. If you said you would have a test method validated, procedure updated, and investigation completed by the end of this month, and you know it’s another two weeks, let them know. They will absolutely respect that and they will prefer that rather than finding out after the fact that you missed that date. There’s a huge fear to let the agency down on those things, but they’re human, they know you’re human, and if they see you making a good-faith effort — and that comes through in your communication, the way you set your tone, the way you talk to them — they will work with you to get compliance, because that’s what they want, ultimately. They want compliance. Prosecuting cases and warning letters and all that takes a lot of their resources, and they don’t want to invoke those or use those unless they have to.

BZ: I will say there are some more sensitive situations where the FDA can be a little harsher. I dealt with a company — it had a number of inspections that had some observations and there was a warning letter in the past. What was happening though in the corrective action planning and then submitting the constant monthly updates to FDA, things would run a bit long. That started to get to be like a tendency that we’d promise something by a certain date and then it would go a bit longer and we’d say, “Oh, we need another amount of time until our next status report to do that.” At some point the compliance team that was running this on FDA got a little miffed at that and they let us know.

Again, I agree with everything John says, but I would say that the best practice is to try to stick to the timelines as much as possible. In a lot of cases, FDA knows what the appropriate timeline should be. If you’re proposing something that’s too long, they’ll let you know. They also will know if you’re proposing to do something right away that’s probably a longer, more drawn out action, they will let you know that you should be doing some other stuff in there to make sure that you’re doing a good job with it.

I also just wanted to add that this idea of being transparent and upfront about what you’re doing is always very helpful and if there can be enforcement involved, can usually lead to a deescalation of that. If the agency really sees you trying to voluntarily comply and take the appropriate actions and being upfront about that and admitting when something has happened and what you need to fix, there will be much less likely to be a gotcha moment later in the interaction where they’ll say “Well, you didn’t tell us about that before, so why is this coming up now?”

Transparency and being honest with what’s going on, to a reasonable extent, will usually help and be beneficial in the entire interaction. There’s this tendency — Joanne and I see this pretty often, I’m sure John has too — to want to lessen how important something is or the critical nature of something, or try to say that something isn’t as bad as it seems to the agency. Not in a direct effort to cover up or to obscure, but just to try to deescalate by saying that thing that you identified isn’t that important. That’s obviously understandable, but if it’s going to lead to something down the road where the agency is going to see evidence of something or be able to identify something to say, “That was more serious than you let on.” Now we’re dealing with something that’s more of an enforcement issue, and you don’t get as much of that goodwill for FDA to try to work with you. If they think you’ve obfuscated or lied, it leads to a more tense enforcement scenario with the agency, and they’re much more willing to bring out the bigger guns.

JD: I would say tense is an understatement, Ben, but I think your initial point gets to responsiveness, right? It sounds like the company responded, but they responded with unrealistic timelines, and then they became less responsive over time. That’s a trap that you can fall into. The other thing I would say as things escalate, obviously, you need to be far more careful. If you’re in a warning letter situation, think of it as a legal document and you’re making legal commitments, because it is? You’re making those commitments. It’s serious enough that the agency has felt they need to warn you. It’s a great name, “warning letter.” They’re warning you: fix this or worse things will happen. And that’s what you’d mentioned, injunction, all those remedies that they have.

Tips for that, if we want to go to some specifics: When you’ve got a warning letter, usually it’s preceded by a 483? Or more, if it’s a corporate warning letter. When you do it, don’t just recycle your 483 responses, because it means the agency has found those lacking. So think deeply, use critical thinking. “What are they telling me?” Look at the questions they ask and think what questions might come from those questions. Sometimes there is the question behind the question. When they ask you for the lot numbers and distribution records for the following SKUs, you can answer that and send that to them — but realize that is probably because they’re thinking you might need to recall that product. So think ahead: Why would they want that information? And then answer and think about it. Should you recall? Is that their way of telling you to recall? Take a look at those questions and go, “Oh, maybe we should.” And maybe your communication is, “Here they are. And by the way, we’ve decided to initiate a recall.” Think about the question beyond the question. As Joanne mentioned earlier, work super hard to make sure everything is factually correct, and double, triple check it. And also think about the connotation, not just the denotation. Don’t crop the photo so that it just shows what you want the agency to see. But also, in any of these things, you may find other things. You don’t necessarily have to open the whole sordid mess right off the bat.

BZ: When we were talking about these issues before recording the podcast, John, you had mentioned a lot about tone to these communications. Can you speak to that for a couple of minutes?

JD: I’ve seen varying approaches to responses. I’ve seen one where the company had hired a law firm that was giving them guidance to be very assertive that you’re in compliance in areas. So they were making statements in response to the FDA’s observations in the warning letter and questions, for example, “Your test method validation appears to be inadequate.” they did a lot of research, they had a lot of people, and in their statement was what they’d done. At the end, they made a declarative statement: “We have reviewed our test method validation and find it to be compliant.” Well, they actually don’t get to make that decision. So that was a very aggressive statement. You could have done all the same work and just changed the sentence to, “Upon reviewing the requirements and the executed test method, we feel it meets the requirements.” That was a pretty aggressive tone and that went throughout their communication. Not the way I would have advised them to respond.

BK: It’s so interesting. I’m hearing a lot of reasons why good communication is so important. And I’m hearing the best practices of transparency, open and honest communication, timely communication, being clear and responsive. All of these things are so important for the listeners to take away. “What do we need to do to ensure these communications go in the right direction?”

Do you all have any more stories to share about a communication that went particularly well, and maybe why it went well? Or one that went very poorly? I feel like everybody always remembers those a little more clearly. What are the lessons learned there?

JD: I have a colleague at Compliance Architects who was brought into a smaller medical device firm. They were recidivist. They’d had more than one warning letter. They were on their second or third. They’d had a series of recalls and they had brought in another firm prior to us and they’d kicked them out because they felt they weren’t getting anywhere.

She went in, she looked at their responses. It was similar issues to what I had talked about. The tone was wrong. They also made promises —that anyone would have realized there was no way they were going to be able to do what they said they would do, which increased the trust deficit. So they called us in the emergency because they had gotten called into a regulatory meeting. And for those who may not know what that is, that’s where the agency says, “We would like to meet with you on whatever the topic is.” They give you a short time to be there and you’ve got to defend the topic.

So she was brought in. They’d gotten the note and they had three weeks to prepare. To your point, she completely rewrote their response, created a new response, phrased it using these principles, was more transparent, forced the company to have realistic timelines. This is back in the days when the agency, or at least CDRH, was district-based. She went into the district and the head of ORA opened the meeting by saying “You are recidivist and we’re having this meeting to give you one last chance because there will be no more letters.” Basically telling them you’re going to go to court. “However, your last response showed us that it seems you’re getting it. So we want to talk about that further.” And with this complete pivot in approach and transparency, they got through it. They got their updates on time. They initiated a bunch of recalls that they would not have done before. It sounds easy on paper, but it’s painful for a business. They built up the trust and their warning letter has since been lifted and they’ve still got things they’re working on, but the change in tone was completely evident to the agency with the one communication in between.

BK: Wow, that sounds like really things really turned around when they changed the approach.

JD: It’s a complete turnaround. And she rightfully is very proud of that accomplishment because for an ORA director to look at you and say, “Tell the company you’re on the verge of being referred to the Department of Justice.” And then in the next sentence say, “But we think there may have been a change, so we’re giving you this last chance to explain.” And it was good. And it was all these principles. It was transparency. It was realistic timeframes. It was documenting and follow-up, and it worked.

JH: That’s a great story, John, and a great example of effective communication in your FDA relationship.

I was going to share the story I alluded to earlier in this discussion where we had a small company that didn’t have commercial products; it was working on investigational devices, essentially. Ben and I got pulled in because the CEO, who was also essentially the lead scientist, had gotten an email from someone at FDA with five or six questions about a clinical trial that they were sponsoring — pretty technical questions. And the response that the CEO sent back violated all the rules that John just talked about. It was dismissive. It was essentially like, “How dare you ask these questions?” I mean, it didn’t say that, but that was the tone of it. It was factually inaccurate and it led to much more scrutiny, a complete investigation, a recall. It was a huge reputational damage to this company, So that is a really good reminder for us of why these things matter. Knowing essentially what not to do. What not to do if you ever get an email from FDA and don’t assume it’s benign.

BZ: I just wanted to add to what Joanne said, they probably have a lot of examples of good communications. I would just say the one we’ve been recently working on with John on our shared client has been a great example of good communication. I think we’d all agree that that client had some fundamental systemic issues, but being able to approach the management team and interact with them early with Joanne and myself as attorneys, and John and his team as the compliance consultants, we were really able to speak with the management people in charge at the company and have them understand why these best practices, these communication practices are important and why we need to approach it the way we do.

Having a management team that was willing to follow that and then have us carry that out and help them carry that out has so far led to a good result and no major issues with the agency. I think that’s a good example.

JD: Yes, because we use the principles internally with their management and the management does want to do the right thing, which is always a big help. Everyone would agree, especially lawyers.

BZ: There’s always that cultural element, yes. If you have a management that is willing to take the steps necessary to be compliant and to communicate well with the agency, it usually works out for the best.

JD: And that gets to another a tip: we could talk about culture. When one of these things occurs, that is the time to stop explaining and start demonstrating. Sometimes the communications are bad because the company will want to explain how or why. Nobody cares. Talk about the situation and demonstrate how you’re going to repair that situation — unless how you got there is part of the solution to never going there again.

Another thing that occurred to me as we were talking about potential war stories and interesting things is: know your language, use the words appropriately. And don’t use jargon. Well, there’s industry jargon you want to use. But I can give you one funny but scary example.

I was at a company that was doing machine learning in medical devices in very early 2016. A very large company. FDA asked us to come in and talk about how it could work in medical devices. So we had meeting with CDRH; it was a big time meeting, but they got to talking about how we did it.

And I had our scientists there and they said, “Well, what if you got a complaint?” We didn’t have a product out yet, but what if you got a complaint on your product on the web? What would you do? And the folks there were like, “It’s very easy to change our API so we could change it very quickly.” And I saw the agency folks on the side reacting. And again, and they kept talking about how easy it was to change the API.

I said, “Hold on folks, I think we got a language problem here.” I turned to my scientist friends and I said, “When you say API, you mean ‘application programming interface.’ But my friends on the other side of the table think you’re saying ‘active pharmaceutical ingredient’ and you cannot be changing that willy nilly.” And I looked at them, said, “Am I right?” They said yes.

BK: How funny.

JD: So I told my boss, I turned to her and I said, “I really think I earned my pay today.”

BK: And I’m sure in your space in the FDA, it’s just as much an alphabet soup as it is on the CMS side of things.

JD: Absolutely, codes and jargon. But people will misuse terms or they’ll use a term in their company that’s not industry standard. They’re using an industry standard term, not in the standard fashion. Don’t ever do that. You’re killing yourself, because you’ll just cause confusion.

BK: On that note, I want to thank you all so much for joining us today. John, Joanne, and Ben, you really gave our listeners so much to think about. And I think that this is such a great episode because it’s some really concrete tips and explanations as to why our clients need you when communicating with the FDA. Listeners, if you have any questions for our guests today, please feel free to reach out directly, or email us at [email protected].

I’m Bridgette Keller and this was Health Law Diagnosed.

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