Ackerman is a partner in Covington’s FDA Regulatory group, where he advises companies and trade associations on complex Food and Drug Administration (FDA) issues. He also co-leads Covington’s multidisciplinary Digital Health Initiative, which advises clients who are using information technology and data to innovate and improve health.
To learn more about the expertise that Ackerman will bring to the Advisory Board, we asked him a few questions about his background and current areas of practice. The conversation touches on a range of topics, from misconceptions about the FDA’s Emergency Use Authorization, to the promise that digital technologies hold in promoting health and wellness. The interview, which has been edited and condensed, follows.
Can you talk about your background and the perspective you’ll bring to the Petrie-Flom Center’s Advisory Board?
I spent a number of years in the federal government in DC — over five years at FDA, and almost three years and the Senate Health Committee overseeing the FDA portfolio.
My practice now at Covington revolves around helping clients, both individual companies and industry trade associations, navigate the evolving FDA regulatory framework.
And I also co-lead our Covington global digital health initiative, which is a cross practice team that was brought together to help our life sciences and technology clients navigate the evolving digital health sector. That work provides me a vantage point into a lot of exciting developments, everything from the movement to home health, to the use of health data and analytics to better understand how drugs and devices work.
So I’m excited to join the Advisory Board, because I bring a perspective of not only the evolving FDA regulatory framework, but also the intersection of legislative changes and public policy, and the future of global digital health and technology efforts.
What do you see as the main areas of promise for digital health?
When it comes to health, I think we’re just at the tip of the iceberg of the exciting digital health horizon, because we’re going to better understand human health disease progression, disease prevention, and wellness and interventions in new ways.
We’re going to have incredible amounts of health data that we’re going to actually be able to utilize, and that follow a person through their life cycle, to help them manage their own health in new ways. We will see disruptive ways of getting health care to people: we’re already seeing that with the expansion of telehealth in the global pandemic. One of the things that makes me even more excited about the digital health space, and the use of data analytics and new technologies to help improve health, is that they offer potential ways to help address health disparities. It’s by no means the silver bullet, because technology itself sometimes can be a barrier, if not deployed and utilized in a thoughtful way. But I do think that technology — as well as the heightened attention given the pandemic — will help society better address health disparities in the future.
When it comes to drugs and medical devices, which is where one area the FDA regulatory framework directly impacts our health, drugs and biologics will continue to play a critical role, as will medical devices, which includes some health software. We also have new ways to collect and analyze data about the safety and effectiveness of medical products, and we’re seeing novel approaches to conduct clinical research. These are all things that FDA is working on, like the agency’s real world evidence program. Also, once products are on the market, we’ll be able to monitor how they’re performing in new and innovative ways.
We’ll also see FDA and other global health regulators change the way they’re leveraging technology to do their own work, including by leveraging new technologies to modernize the way drug and device sponsors communicate with their regulators.
What do you perceive as the main areas of concern?
One challenge is that just collecting more data, and having more data to analyze doesn’t necessarily mean we are advancing health and wellness, or that we are preventing disease or improving disease treatment. The volume of data is itself a challenge. And I think that is a place that will continue to see innovation, how to curate and link data to make it more meaningful and usable for the intended purpose.
When we’re talking about health data, one area everyone’s always appropriately focused on is privacy, and cybersecurity, how do we protect important information as the use of these technologies advance? How do we ensure data sharing is appropriate? Many regulators have policies on the books that were written before the current era of sophisticated data and data analytics, so policies need updating.
How should the regulatory landscape change to encourage growth and/or to guard against risk?
The health regulator’s role is as important as ever, when you’re talking about advancing digital health solutions. You need that trust around these solutions within the health care system and providers, and with patients, their families, and caregivers. But at the same time, regulators can’t be applying a square peg into a round hole.
What I worked on when I was last on the Hill, the 21st Century Cures Act, was thinking along these lines — how does Congress preserve the high standards of regulatory oversight, while ensuring the approaches are updated to reflect the kinds of innovations that are now coming before the regulators. While the 21st Century Cures Act made a number of important changes, there’s more work to be done.
People are talking about the FDA and key FDA terms, like EUA, like never before. Are there certain things you think the conversation is missing, or misconceptions you’d want to clarify for people?
The EUA authorizations are important agency decisions. The EUA authority is a power that FDA has at its discretion in emergency situations. When you look about how FDA has applied that authority in the COVID-19 pandemic, they have often required robust clinical studies in order to grant these authorizations. And I think we’re accordingly seeing public trust in the products that FDA has authorized using the EUA authority.
What are you looking forward to about being a part of the Petrie-Flom Center’s Advisory Board?
I’m delighted to join the Board and hear even more about the exciting work that the Center is doing. And I’m excited to meet the other members of the Board, and the students that are engaged in the Center. The sharing of ideas on these issues not only excites me, but ultimately can have a great impact on public health.