Democratic senators voiced concerns during a confirmation hearing on Wednesday that President Donald Trump’s pick to lead the Food and Drug Administration was too entangled with the industry he is tasked to oversee, pointing specifically to his investments in digital health companies.
Nominated last month to serve as FDA commissioner, Scott Gottlieb, M.D. has been criticized for his close ties to the pharmaceutical and medical device industries. Those criticisms were on full display during a Senate confirmation hearing on Wednesday, when Sen. Patty Murry (D-Wash.) emphasized Gottlieb’s “unprecedented financial entanglements with industries he would regulate as FDA commissioner.”
Murray took specific issue with a 2012 article in which Gottlieb was quoted questioning why a smartphone app that tracks blood sugar levels requires FDA clearance. At the time, Gottlieb had invested in Glytec, a company that uses app-based technology to provide personalized diabetes therapy management.
“It does trouble me that you appear to be investing in and advising a company and then using your public platform to promote policies that actually benefit that company in the future,” Murray said.
Although Gottlieb worked in the FDA during the George W. Bush administration, he has spent the last 10 years as a partner at the venture capital firm New Enterprise Associates. In a letter (PDF) to the Office of Government Ethics, Gottlieb indicated that he would resign from several healthcare companies and divest in several others, including Glytec and Medavante, a data collection platform designed to improve clinical trials.
Others questioned whether Gottlieb’s objectivity would be compromised when an NEA-backed company came before the FDA. He said he was cognizant of his role as FDA commissioner and would “do nothing that would besmirch the agency.”
“This is exceedingly important to me,” he said. “I get it. I know why people care. The FDA’s decisions are literally matters of life and death.”
Gottlieb’s experience as a venture capitalist is exactly what makes him appealing to the digital health industry. Last month, industry experts told FierceHealthcare Gottlieb brings an open-minded and balanced approach to the agency, and his emphasis on deregulation could impact how he implements provisions of the 21st Century Cures Act and enforces recent FDA guidance on mHealth products.
Addressing concerns that his past investments could cloud his judgment as commissioner, Gottlieb vowed to work with the Office of Government Ethics to take additional steps where necessary, but stood by his prior work with the pharmaceutical and medical device industries.
“The things I’ve done—my accomplishments, my failures and everything in between—have shaped who I am today,” he said.” Collectively, they have helped inform my values and my perspective. But among other things, they have taught me the need for an absolutely objective regulatory watchdog over this field.”