Though he only held the position for just under two years, FDA Commissioner Dr. Scott Gottlieb said that he believes the agency’s scope has expanded significantly during his time at its head, according to a FierceBiotech report.
The report comes from a fireside-style chat hosted by the Alliance for a Stronger FDA and the Pew Charitable Trusts in Washington, D.C., according to the report, at which Gottlieb spoke to a group including former FDA head Mark McClellan.
“I think what’s changed most notably about the agency from the time I was there was that the scope has expanded so dramatically, in not a long period of time,” Gottlieb said, according to FierceBiotech.
During his tenure, which began in May 2017, the FDA has expanded its framework to consider how to handle a number of new digital health products, significant advances in regenerative medicine and a changing healthcare landscape, according to the report.
“These are dramatic expansions in the scope of the work that we do. It’s really changed the contours of the agency’s mission, and has made it far more diverse and vast. We actually had to conceive of different ways of regulating,” Gottlieb said, according to FierceBiotech.
Gottlieb also touted that the agency has approved a record number of new drugs under his guidance, reportedly apologizing to the attending former head McClellan for breaking his previously established record.
When asked about the current debate over rising drug prices, Gottlieb said that he will “have a lot more to say on that” after he steps down from the position at the end of this week, according to FierceBiotech.
As for his biggest worries for the agency after he steps away, Gottlieb said that he’s concerned about the possibility catastrophic risks being widely distributed before they’re caught by the federal watchdog, with specific concerns over food products and blood, according to the report.
“I mean, aside from waking up and seeing a tweet about me in the morning – that has always worried me,” Gottlieb said, according to FierceBiotech.
Gottlieb threw his support behind the incoming interim commissioner, current National Cancer Institute head Dr. Norman “Ned” Sharpless, who was tapped to lead the agency last month.
“He’s exceptionally public health-minded, and an outstanding clinician, as well as an inventor himself,” Gottlieb said, according to FierceBiotech.
Gottlieb also said that he has “extreme confidence” in the leadership at the agency, including recently added principal deputy commissioner Amy Abernathy and long-time center directors Janet Woodcock, Peter Marks and Jeffery Shuren, according to the report.
“So all the policy I worked on was formulated in concert with them and their staff. It all came out of the centers, and I think that made it successful. And it made sure that we had a broad consensus around what we were doing,” Gottlieb said, according to FierceBiotech.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.