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 Law360, in “Grading Gottlieb: How Attys View FDA Chief’s First 6 Months,” by Jeff Overley. (Read the full version – subscription required.)
Following is an excerpt:
In Scott Gottlieb’s first six months as U.S. Food and Drug Administration chief, he has moved rapidly to streamline approvals and has become something of a rock-star regulator who tweets energetically about everything from gene therapy to skinny jeans.
Gottlieb, who was sworn in as FDA commissioner on May 11, has prioritized quicker approvals of prescription drugs and medical devices, including direct-to-consumer DNA tests and digital health software. In doing so, he has adopted a relatively freewheeling public posture — including an enthusiastic embrace of social media — that has lent a subtle aura of coolness to the wonky world of FDA policymaking. …
Bradley Merrill Thompson, an Epstein Becker Green member, noted that Gottlieb hasn’t yet taken action on many thorny topics, such as how laboratory-developed tests should be regulated. But he called Gottlieb’s work so far a significant down payment on the device industry’s sought-after policy changes and clarifications.
“I really do feel as though the Gottlieb-led FDA has been making earnest progress,” Thompson said. “There is certainly a huge amount of work yet to be done — indeed most of the actual work — but I certainly didn’t expect all of that to be completed in the first six months.”
