Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FierceHealthcare, in “3 Ways Trump’s FDA Nominee Could Reshape Digital Health,” by Evan Sweeney.
Following is an excerpt:
Changing the FDA’s enforcement culture may be easier said than done, according to Bradley Merrill Thompson, an attorney with Epstein Becker & Green. Thompson declined to comment on Gottlieb’s nomination but noted that although the FDA’s guidance documents offer additional leniency for digital entrepreneurs, they are also written broadly to allow for significant latitude. Those companies that run up against FDA oversight are often stymied by the agency’s conservative psychology.
“Very few people at FDA get patted on the back for approving things quickly,” he said. “But they get congratulated if they keep an unsafe product off the market.”