Since there’s nothing more fascinating than a peek behind the curtain, Stanford Biodesign’s most recent “From the Innovator’s Workbench” event featuring former FDA commissioner from 2017 to 2019, Scott Gottlieb, MD, was a big draw.
More than 400 people attended the virtual event, co-sponsored by Fogarty Innovation and Wilson Sonsini Goodrich & Rosati (WSGR). Moderators included Stanford Biodesign’s director Paul Yock, MD, and Fogarty Innovation’s CEO Andrew Cleeland; with WSGR partner Casey McGlynn who shared a tribute to the late Tracy Lefteroff, a former Fogarty Innovation board member. The event was held in honor of his innumerable contributions to the industry.
A diversified career
Currently a special partner on the NEA healthcare investment team, Scott brought a deep knowledge of the industry to his role with the FDA, earned through a variety of previous posts—as an investment banking analyst, practicing physician, prolific writer and influential figure in the biotech industry.
Even as a medical student, Scott was published regularly in prominent media outlets, writing about healthcare reform and healthcare issues. After starting in medical practice as a hospitalist, he was offered a position at the American Enterprise Institute, a Washington D.C. think tank, where he frequently wrote about FDA-related regulatory issues.
This well-rounded view of healthcare—from capital markets to medical school to writing and analyzing—provided Scott unparalleled insight into all facets of the business and a unique perspective as he joined the FDA. “Having touched all these bases gave me the ability to be effective at implementing policy because I could speak the medical lexicon,” he noted.
Leading a “mission-driven” FDA
As FDA commissioner, Scott built a culture that was centered on the context of a shared mission, coalescing around the public health goals the agency was trying to achieve. He believed it was vital to be transparent and offer clear guidance on how companies should develop their products in order to de-risk them and deliver a concept that would be well received by investors, payors and the end users.
“People at the FDA have a real sense that the agency’s work is advancing public health, which comes not just by protecting consumers from things that might not be safe, but also introducing things that are going to improve medical outcomes,” he said.
One of his keys to success was a focus on educating members of Congress, testifying at least monthly and meeting with them regularly, rather than just focusing on issues when they reached the spotlight. Cultivating these relationships helped the FDA work constructively on legislation.
Views on medtech
While Scott supported the FDA’s role in preventing unsafe products from reaching consumers, he also thought that innovative medical devices should get to patients sooner, so they can start making a difference faster.
One advance he finds highly beneficial is the FDA’s Breakthrough Devices Program, which comes with a guarantee of basic level of Medicare coverage, lowering the cost of capital to develop the device. However, he cautioned that the designation should be used sparingly so as not to lose meaning.
He also acknowledged that approval can be harder for devices than drugs that are often part of a large classification. “Medical devices are tools in the hands of physicians. You can’t evaluate devices apart from how they are going to be used, so training programs and other activities of the companies take on greater importance,” he said.
The pandemic spurred what Scott calls “a cultural change” in the behaviors and desires of consumers, and a key one that he sees continuing in the healthcare sector is a broader adoption and trust of telehealth. He also predicts an increase in at-home diagnostic testing, which, although it can introduce risks, ultimately also advances public health in his opinion.
Because some patients have been uneasy about seeking treatment during the pandemic and many elective surgeries were prohibited for a period, he believes we will start to see a temporary surge in later-stage presentations of life-threatening conditions. On the upside, hospitals are building out capacity so they can handle the influx.
COVID-related opportunities in the medical device space are likely to center around building more resiliency into the system to allow the ability to quickly expand capacity. While stockpiling respirators is the most obvious solution, there are also innovations that can help make care more efficient and extend the utility of providers in an emergency situation.
Leaving behind a legacy
As Scott reflected on his career to date, he says one of his most notable accomplishments during his tenure as FDA commissioner is changing the perspective of the agency’s role with respect to important public health problems, including playing a vital role in reducing addiction caused by the over-prescription of opioids.
“I’m proud of the ways I felt I could positively change the agency’s view with respect to a public health problem, because that’s going to have the most enduring impact, much more durable than getting a guidance out or even getting a regulation implemented,” he said.