I admit, the title of this post is an attempt at a ham-fisted connection between the FDA’s impressive, forward-looking digital strategy under Commissioner Scott Gottlieb (as he wraps up his post following his March 5th resignation) and an overall reckoning from his tenure. I also must admit that my assessment has some shortcomings: I watch the FDA from a distance, avoid the political elements and focus only on the medtech industry (drug prices, generic approvals and vaping notwithstanding). Although Jeffrey Shuren, the director of the Center for Devices and Radiological Health, and others at the FDA probably should share credit for many of the positive accomplishments in medtech, the tenure of a leader should be judged by the organization’s accomplishments during that time. As Gottlieb prepares to move on from his role in public service, I’d like to share a few thoughts on the agency’s recent impact on the medtech industry.
The “Ones,” or The Things That We’ve Won
First and foremost, the FDA’s pace in leading the way with digital medicine is probably the most defining achievement of Gottlieb’s tenure and, in my eyes, perhaps the most forward-looking. Digital and connected health tools offer amazing benefits but cannot get mired in regulation. Precedents established in how the FDA chose to regulate software, especially things like clinical software, moved at a comparatively glacial pace. Now we see true digital health innovation, and a lot of it, under the current FDA rules. Reasonable expectations and clear guidelines exist for certification and approval in digital health, which is all quite new and progressive.
Some will say that Apple’s EKG wearables application was approved inappropriately fast when it clocked in at 30 days and slipped in just in time for a shareholder announcement. But to me, Apple’s foray into the world of health tech was a much-needed wake-up call for traditional medtech. I’m convinced that the consumerization of healthcare, especially when it leads to behavior change and consumer awareness of managing chronic disease, is a very good thing. We need new competitors to challenge our industry’s long-held beliefs and to harness the tremendous opportunities that exist when technology is unleashed on our industry, but we still need a thoughtful regulating body looking after privacy and cybersecurity concerns. Given the tremendous risk that these “weapons of math destruction” could bring to our industry, I like what I see in the FDA’s approach.
Another big win is an accelerated provisional approval process for medical devices that’s coming at a time when Europe, the world’s traditional launch-proving grounds, is rolling out medical device regulations that threaten to complicate and slow approvals. What I like most is the FDA’s desire to push the use of real-world evidence to further establish and drive the maintenance of approvals. The establishment of registries and use of RWE will be key factors that contribute to the long-term justification of medical devices. This is a very progressive view that not only helps improve access for patients but also encourages the use of RWE to establish interventions’ economic and clinical efficacy.
The “Zeros,” or The Things That We Didn’t Lose
First, let’s raise a glass to open communication and transparency with “zero” drama. Is it possible for a public figure to frequently use Twitter to directly communicate messages and regulatory philosophies without creating divisive rhetoric, polarizing headlines and counter-productive public disputes? Despite evidence to the contrary from the big boss, Gottlieb seemed to be that example. I’m not alone in viewing his periodic communications as clear, consistent and helpfully transparent.
And that’s not to say that the FDA’s stance was never challenged under Gottlieb: Last year, the International Consortium of Investigative Journalists (ICIJ) released its enormous exposé, “Implant Files,” and then there was the polarizing Netflix documentary called The Bleeding Edge. For a few moments, it felt like there could be a wave of bad press and negative energy around the industry. Instead, we saw careful statements, some measured action (for example, issuing an update to the 510(k) clearance pathway and removing specific devices from the U.S. market) and then nothing more. It blew over. Some change is always good when legitimate issues come to light, but I felt that there were significant risks in the harm and overreaction. But under Gottlieb’s FDA, the negative impact amounted to “zero.”
How about getting “zero” funding for 35 days and recovering to business-as-usual quickly after the longest shutdown in U.S. government history? It seems that the FDA’s medtech-related performance in early 2019 was only modestly impacted by the furlough, and it seems hard to remember that it has been shut down almost more than it has been open this year.
Wading into regulatory affairs is somewhat uncharted territory for me, but after watching nearly two years of Scott Gottlieb at the FDA’s helm, I felt compelled to reflect on one of the most public and competent areas of the current administration and to give credit where credit is due: to the “wins” of the Gottlieb FDA.