Shook Partner Adrienne Byard and Of Counsel Kristin Kaplan discuss predictions for the U.S. Food and Drug Administration in 2021 and beyond.
It’s no secret a new administration will want to make its own mark. This could mean a rollback of regulations from the previous administration or changes to the regulations, but perhaps most importantly, it could entail a change of the enforcement discretion and how it’s exercised. Any of these changes will ultimately impact business. I’m Adrienne Byard, a product liability litigation partner at Shook, Hardy & Bacon.
I’m joined today by Kristin Kaplan, an experienced FDA regulatory attorney who has recently joined the firm. Kristin brings a wealth of experience, having served as associate chief counsel at the FDA, and then deputy general counsel in charge of global regulatory legal support and litigation program for one of the world’s largest animal health companies. She joins me now to talk about what regulatory changes we might see. Kristin, welcome to the firm.
Thank you, Adrienne. It’s great to be here.
You have keen insight having been at the agency. What do you think companies need to be watching for now as a new administration begins to set priorities?
This is a very popular question these days, especially as there is increased interest in who the administration will name as the new FDA commissioner. I think there are several things companies can begin to look at as they sort of digest what the agency priorities might be in the coming months and years.
The first thing to look at is whether there will be an uptick in FDA warning letters. There was a decrease in warning letters between President Obama and President Trump, and we are likely see an uptick with President Biden. We have already seen this in a number of different areas. One is advertising- and promotion-related warning letters talking about commercial advertising on fair balance or overstated efficacy claims. Another is a continued increase in warning letters related to COVID-19-related products.
A third is FDA warning letters related to food allergens or food-allergen labeling. And this is likely to get even greater focus because Congress just passed the FASTER Act, which named sesame the ninth major food allergen to be included on labels.
And then, finally, we’ve also seen an uptick in CBD-related warning letters in the initial months of the Biden administration. So those are a few hints. In addition, the acting commissioner, Dr. Woodcock, recently mentioned she will have a focus on food safety and animal health. So those are a couple of things to keep in mind.
Another place to look is whether there will be increased inspections. FDA did very few inspections at all and basically no in-person inspections last year because of COVID-19. We expect that that will change as the restrictions related to COVID-19 lift a little bit.
The last place to look is once there is a nominee for the commissioner, it will be important to take note of the confirmation process and what he or she says during the confirmation process, as that usually provides early hints as to what their priorities might be.
What do you see on the horizon in terms of enforcement, then?
Enforcement—so, it will likely dovetail nicely with the warning letter issues. We will likely see enforcement related to COVID, and increases in inspections could lead to additional sources of warning letters and also could be a signal of increased potential enforcement activities, depending on what those inspections find. I would say that we will likely see a return to a more active enforcement approach by this administration compared to the prior administration, and this administration has seemed, so far, to demonstrate a desire to distinguish itself from the Trump Administration, which could mean a tougher stance on certain issues.
What should we make of these transparency initiatives at the agency? What does that mean in terms of the ability to engage in formal communications with the agency or any expectation that there will be confidential treatment of information?
It’s a good question, and one that’s particularly important to businesses as they determine what and how to submit information to both FDA and other regulatory agencies—this isn’t a FDA-specific question. The conventional wisdom is that Democratic administrations are more focused on transparency than Republican administrations. It remains to be seen a bit whether that conventional wisdom will hold true for this administration.
If the Biden Administration follows that conventional wisdom, then we might look for pressure for FDA and the other executive agencies to be more transparent about what companies send to the agency and to take a narrower view of what can be held as confidential business information. However, we also have to keep in mind that there are evolving privacy laws, sort of across the United States and certainly outside the United States, and existing statutes like the Freedom of Information Act, that do protect the confidentiality of certain types of information. So those statutes won’t go away—it’s more of a question of how the agencies and the administration will interpret them.
This is why I’m so happy to be at Shook and have the opportunity to partner litigation defense with regulatory counseling—because it’s so important that the information be contextualized that’s provided by the agency. For instance, when it comes to safety information or risk monitoring, when that information is based on case reports, that the limitations of that information or that data are acknowledged or that they’re put into context with other known causes of these adverse outcomes.
Changing gears, then, I think, too, Shook is known for its trial strength. I come from the litigation side of the house, and you come from the regulatory side, but I do think what sets our firm apart is understanding how these two services—or these two disciplines—work together, don’t you?
I totally agree, and it’s one of the reasons I was most excited to join Shook. The two disciplines really are interrelated, and they impact each other. And I think many clients need help understanding the interrelated nature of the two disciplines and how they play off of each other.
It’s really important from my perspective to build a team that understands both in order to be most successful both in terms of regulatory strategy and in terms of litigation strategy. So, for example, media and litigation can spur action by FDA or other regulatory agencies; similarly, action by FDA can spur litigation or media attention, or both. That’s why I think it’s important to keep both perspectives in mind when building both a litigation and a regulatory strategy and approach.
In addition, it’s incredibly important to have a regulatory lens for any product-related litigation in the FDA space because the regulatory framework can impact the strength of the arguments and a skilled regulatory attorney may be able to identify strategies and legal theories that aren’t immediately obvious by reading the statute and the regulations. Sometimes what the statutory terms and regulatory terms look like on their face and how FDA has interpreted them are very different.
In addition, even pre-approval and pre-litigation—so, when you’re in the research and development, or product development, stage—it’s important to have a litigation point of view in mind because often what happens in the regulatory framework and the administrative record before the agency becomes key in future litigation, and the strength of your administrative record can make or break arguments that you could make in the litigation context—for example, preemption-related arguments.
That’s absolutely right. Well, Kristin, it’s been a pleasure speaking with you today—it’s a pleasure to partner with you. Thank you so much.