Key Takeaways from Today's Scott Gottlieb Interview

Ryan Black
MARCH 28, 2018

Photo Credit: David Grogan/CNBC. Image has been cropped for size.


At the CNBC Healthy Returns conference today in New York City, reporter Meg Tirrell sat down with FDA Commissioner Scott Gottlieb, MD, to talk about his tenure so far at the agency. Here’s 5 things that he expressed during their conversation:

We’re at a “defining moment” for new medical tech. Those are his words, not ours. With all of the new technologies working their way into healthcare—whether they’re digital interventions, gene therapy, or cell regeneration—the Commissioner said that his agency is “setting the rules,” and that, “I think continuing to open up opportunities for this new technology to mature is going to be very important.”

A wait-and-see response to Right-to-Try. Gottlieb toed the line when it came to controversial “Right-to-Try” legislation, versions of which have successfully worked their way through Congress. Gottlieb has never given the idea a beaming endorsement, but he and the FDA have worked with Congress to refine the bill.

“To the extent that this legislation can provide some incremental opportunity to patients, we're supportive of the general concept and will continue to work with Congress as they sort of work through this process to try to make some kind of legislation work in this way,” he said.

And also to the CVS-Aetna merger. The Commissioner has repeatedly expressed an interest in using biosimilars to bring down drug costs. In that context, he was asked about how the continuously-consolidating pharmacy benefits management (PBM) landscape—including CVS’s proposed purchase of insurer Aetna—would impact that. He said that it “remains to be seen,” and quickly returned to talking about pharmaceutical rebates (he said he was encouraged by the growing number of health plans paying the rebates directly to patients).

An increasingly intense focus on public health. “I think the most important thing that we can do is get back to public health basics: Reduce smoking rates, promote healthy diets, promote vaccination rates,” he said. Since FDA operates through evidence-based regulations, some proponents might say the Commissioner was talking about “population health,” but that’s neither he nor there.  

The agency recently announced measures to cut down the nicotine levels in combustible cigarettes, but the Commissioner left open the door for alternative nicotine sources: “One of the things we're doing right now is looking very actively at could we bring an e-cigarette through the over-the-counter pathway,” he said, adding that the agency was looking for a way to have nicotine sold through pharmaceutical pathways for smoking cessation.

“I’m going to make some announcements tomorrow about nutrition,” he added.

He can’t confirm or deny whether he’s a robot. After listing off the numerous changes at the agency since his ascent and mentioning that he still had time to Tweet, Tirrell asked Gottlieb if he was a robot.

“Well, the tweeting isn't the robot. That's really me,” the FDA Commissioner said.

Related Coverage:
FDA Streamlines Review Pathway for Certain Glucose Monitoring Devices
FDA Establishes Precedent by Approving AI-Powered Stroke Triage Software
Predictive Patient Surveillance System Receives FDA Clearance
 

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