Law360 (March 26, 2020, 8:40 PM EDT) -- In an interview with Law360, the co-chair of the U.S. Food and Drug Administration practice at Buchanan Ingersoll & Rooney PC shared his advice for dealing with the agency during the coronavirus crisis and discussed how FDA policies may change in the aftermath.
Edward John Allera
Allera, who also was an associate chief counsel at the FDA from 1974 to 1979, earned a bachelor's degree in pharmacy at West Virginia University and a law degree from the Georgetown University Law Center.
This interview has been edited for length and clarity.
What advice do you have for lawyers interacting with the FDA on non-coronavirus issues when the agency is so focused on the crisis?
Stay with the basics. Everyone is under pressure: FDA, clients and attorneys. Grace under pressure is an adage for a reason.
As I used to tell my sons, "You never have to apologize for behaving like a gentleman." Behave like a professional. The crisis will pass, and you don't want to have destroyed your reputation in a snit.
What's one short-term step the FDA could take to further assist with the crisis response?
I think that one step is to announce and explain that processes exist and are being followed. Please follow the processes. Tell your story in the ways and formats that exist.
The agency understands that holes will exist in your story, but it is processing these submissions [for product approvals] rapidly and in a way that has an expanded consideration of the benefits and a realistic understanding of the risks.
What are one or two long-term steps the FDA could take to improve the nation's ability to deal with viral outbreaks?
First, we need clarity on procedures to create laboratory developed tests, or LDTs, for future pathogens. We know that these outbreaks occur every five years or so, and we need to have procedures in place to facilitate tests.
Second, we need to consider supply chain issues and possible autarky for strategic products. Should a strategic formulary exist that is built on products that are completely developed and produced in the U.S. or in accord with the U.S.-Mexico-Canada Agreement? Can those products use special labeling or coding to identify them, so the health care professionals or consumers can identify them? Can they get special listing in formularies?
What are the most important FDA activities that have been affected by the pandemic?
One change is that they have accelerated diagnostic tests for the novel coronavirus. What's also intriguing is that historically, our diagnostic testing system was designed to have a health care professional as an intermediary. When AIDS was big, there was concern about going directly to the patient, because if the patient got a positive result, they would be overwhelmed. So we've always historically had this health care intermediary in the middle. And now we seem to be moving toward direct testing of individuals.
How that will play out in the future, I don't know. But it merits discussion. I think what's going to happen is this pandemic is going to open our eyes to, "Historically, we've done it this way, but do we need to change?"
Could you talk more about that? I feel like people are starting to ask how this crisis might change the agency in lasting ways.
FDA's always learned from crises. AIDS was huge — it completely revamped the new drug approval system. And then all of the expedited reviews were put into place based on crises. And now we have another crisis.
Does it make sense for us to review all of these expedited procedures and consolidate them? We have user-fee legislation that's due in 2022 [and could be a vehicle for changes]. And I think a number of these things will be looked at as, "How can we improve this process? What have we learned, and how can we improve it?"
Some people say the FDA could have acted sooner than March 16 to relax approval standards for coronavirus tests — what might the agency do to address this issue when it's eventually scrutinized by Congress?
I think that the role of diagnostics — from LDTs to direct-to-consumer diagnostics — merits a thorough review. The role of LDTs has been the subject of debate for over a decade. When President Obama was a senator, he co-sponsored legislation on deregulation of LDTs.
As people have access to personal health care information and demand more, should we expand the scope of direct-to-consumer devices? In times of crisis, we need to create a mechanism or system to facilitate development of such tests. We should also consider the rigor that is acceptable for such tests.
Does anything else come to mind in terms of questions the agency might face from Congress in the aftermath of the crisis?
They always face questions from Congress — that's never-ending. FDA was once described as a large, slow-moving target that bleeds easily and profusely. So they will be dragged down and questioned about things. But we won't know [the issues] until things turn around and we have a chance to digest what's happened.
I'm optimistic that the most important oversight will be, "Are there changes we need to make in our system? Are there systematic changes that we need to make?" Hopefully it will be more along those lines.
--Editing by Aaron Pelc.
This is part of a series of Law360 conversations with attorneys about the coronavirus. For previous articles, see here and here.
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