When a manufacturer works within the constraints of a highly regulated industry like MedTech, situations will undoubtedly arise when opening a line of communication with the US Food and Drug Administration (FDA) becomes appropriate, or even necessary.
Whether it’s a problem that crops up on the pre-market side during the review of a novel product or on the post-market surveillance side when reliable data is unavailable – and every imaginable issue and topic in between – keeping a cool head and knowing where to turn within the agency can make all the difference and help a company chart a positive path forward.
When a company makes the decision to reach out to the FDA, its first step should be to contact the pre-market, post-market, or compliance team that will serve as the first line of review, said Sean Boyd, QualityHub’s corporate VP and a 31-year veteran of the agency. He stressed that resolving issues at the ground level of the FDA’s Center for Devices and Radiological Health (CDRH) is often the fastest and most accessible way to gain a resolution because a review team can swiftly field technical, submission, or issue-specific questions.
“Start with a review team because that’s where the most knowledgeable people and most intimately involved people are within the device center,” said Boyd, who recently spoke on the topic of CDRH engagement at King & Spalding’s 18th Annual Medical Device Summit. “The team will know all the details of the issue that the company has provided, conduct their own internal reviews, and perhaps even pull in some additional data or experts to determine if there are more issues to discuss with the company beyond the single issue that was brought to the agency.”
Should a manufacturer and an FDA review team come to an impasse, the company can escalate the issue to CDRH management to gain additional review or meet for a conversation. Boyd recommends meeting first with a team assistant director and moving up the chain of command to a division or office director if necessary.
“This could happen when there’s a difference of opinion between the company’s team and the device center’s review team, and the company wants to hear an additional perspective from a first- or second-line manager,” Boyd said.
“An escalation could also happen if, say, a manufacturer receives a warning letter that includes issues that will take a long time to fix. Perhaps the review team in that situation tells the company it needs to fix its issues faster when the company knows more time is needed,” he added. “Or perhaps the review team says the warning letter remediation plan put in place by the manufacturer contains gaps or isn’t acceptable but the company believes the plan is solid and correct. Escalating further up the chain could be helpful in these types of situations.”
Boyd also pointed out that involving CDRH leaders could be appropriate if a company proposes an alternative to a standard process that the agency expects industry to follow.
“If you want senior leadership advice on whether an alternative is acceptable or if there’s a pathway to a compromise regarding a creative or innovative practice that you want to try, then an escalation is a way to do that,” he said. “There may be a perspective that that a more senior leader can offer to say, ‘I know we haven’t tried that alternative approach for this particular device or situation but maybe it’s worth considering something different.’”
Tell A Complete Story
When engaging with the FDA, it’s vital for a manufacturer to tell its full story by framing highly technical, complex, and voluminous material in the context of a “big picture,” explaining the issue at hand, how the company plans to handle it, and the outcome that is sought. The agency will also want to know when milestones will be accomplished and efforts completed.
“Putting this in the context of the compliance and enforcement space, a company could have an inspection, receive inspectional observations, and be sent a warning letter that outlines various violations, and the company certainly must respond to those observations and violations and say, ‘Here’s what we’re doing to correct X, Y, and Z,’” Boyd said. “And for particularly complex, long term, involved actions, a company will need to have that big picture of what the problem is, what the firm is going to do about it systematically, and a timeline for making corrections. Things are going to change after Day One, and two years down the road you might have to explain any changes you made to remediation plans in the context of where you started.
“So, it’s helpful to have that big picture story in front of the agency, as well as the discrete fixes to the problems that have been identified and the company is addressing,” he added.
Telling a complete story is also important if a company is asking the FDA for permission to use an alternative approach in tackling a problem.
“You have to do a good job of presenting that approach,” Boyd said. “What’s the standard approach that the agency requires? Why doesn’t that work? In this case, what are you going to do differently? How does that mitigate any potential concerns or risks that the agency might have, and how do you assure the agency that the approach you’re going to take is correct and will accomplish the big picture goal of protecting patients and ensuring access to technology?”
Don’t Fear FDA Engagement
There are manufacturers, however, who might shy away from escalating an issue out of fear of reprisal from FDA officials – but Boyd says such concerns aren’t warranted because agency staff are there to help, not hinder.
“FDA officials are people and you will encounter all types of personalities within the agency just as you would within your company. While you may encounter a more challenging individual, I believe that’s most definitely the exception and not the rule,” he said. “The vast majority of agency officials are willing to work with – and partner with – a company to get issues resolved. Now, ‘partner’ is a word that made some people uncomfortable when I was with the FDA because the agency is the overseer, the regulator, and is necessarily focused on public health and patient safety. I personally don’t believe it’s a problem for FDA officials to view industry as a partner to ensure patients have access to the best medical products when they need them most.”
Boyd went on: “We all have a job to do, and the FDA’s job is to protect, promote, and advance the health and safety of the nation. That is its focus. At the same time, I believe people should proactively bring issues to the agency and be more transparent. After all, the FDA wants you to share your problems and solutions early on so the agency doesn’t have to find them for you and then have to say, ‘Hey, are you aware of this? What are you doing about it?’”
He does acknowledge, though, that there are situations when a manufacturer probably shouldn’t engage with CDRH or delay that interaction until the time is right.
“If you’re in the middle of an investigation because, say, your device isn’t performing as expected and you are working to identify a root cause and decide what actions you may consider to address the issue, then it would make sense to do that before reaching out and engaging,” Boyd said. “But in general, don’t be afraid to talk to the FDA. They’re there to support you in their public health mission – which is a shared mission with industry.”
Nevertheless, should a company reach out and have a poor interaction with an official unable to resolve a dispute, Boyd reminds firms that they can contact the agency’s ombudsman or a higher-level official for a resolution, but he notes that those types of situations are rare.
“When I was a CDRH official, I could count on one hand the number of times I had to work with the ombudsman over the span of a decade,” said Boyd, who left the agency’s employ earlier this year. “This is most likely due to the issues within my span of control during my time with FDA, and am certain the ombudsman was busy resolving many issues across the larger organization.”