“The departure of Scott Gottlieb from the U.S. Food and Drug Administration on Tuesday is a potential blow to Silicon Valley,” Christina Farr reports for CNBC. “In his two years as commissioner of the FDA, Gottlieb, a doctor and former venture capitalist, gained a reputation as a proponent of health-care innovation, including pharmaceutical companies bringing new drugs to market.”
“He helped to establish a digital health software program called Pre-Cert to provide a way for tech companies like Apple and Samsung to get quicker approval for low-risk health products,” Farr reports. “Last September, Apple received clearance to market an electrocardiogram app and sensor on its Apple Watch, the company’s biggest move into the health-care market. Gottlieb issued a statement at the time to encourage Apple and other tech companies to push into health care, especially if they could help consumers engage more proactively with their health.”
“Robin Goldstein, who worked on Apple’s health team before stepping down in late 2017, said Gottlieb’s efforts were applauded in the tech sector,” Farr reports. “In his resignation letter to Health and Human Services Secretary Alex Azar, Gottlieb didn’t say why he was leaving. President Trump sent two tweets announcing [Gottlieb]’s departure, but didn’t say what spurred the change.”
Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month….
— Donald J. Trump (@realDonaldTrump) March 5, 2019
….Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!
— Donald J. Trump (@realDonaldTrump) March 5, 2019
Read more in the full article here.
MacDailyNews Take: Hopefully, Gottlieb’s replacement will be just as, or even more, amenable to Apple’s future low-risk health products.
More info about the U.S. FDA’s Digital Health Software Pre-certification (Pre-Cert) Program here.
More info about the U.S. FDA’s Digital Health Innovation Action Plan here.
SEE ALSO:
Apple Watch Series 4 ECG should pave way for more medical gadgets, U.S. FDA says – September 20, 2018
U.S. FDA selects participants, including Apple, for new digital health software precertification pilot program – September 26, 2017
Hopefully Mr. Drump, the fast food king, won’t put some pro heart attack fat bastard in there.
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Gottlieb’s initiatives aimed at fostering innovation in healthcare led to the FDA’s embrace of novel approaches to regulation, particularly in the rapidly evolving field of digital health. His departure may create uncertainty regarding the future direction of FDA Attorney and regulations, which could impact companies investing in healthcare innovation, including tech firms like Apple.