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We’re about to lose the most tech-savvy FDA chief in recent memory, writes Pratap Khedkar.
We’re about to lose the most tech-savvy FDA chief in recent memory. FDA Commissioner Scott Gottlieb, who announced his resignation on March 5, has left quite a mark in his two-year stint at the agency. Under his forward-looking tutelage, the FDA recently proposed several frameworks to streamline healthcare’s adoption of new technologies and has even received industry nods for venturing beyond what’s traditionally thought of as the agency’s purview. From gene therapies to mobile apps and wearable medical devices, healthcare has a different look than it did even a decade ago-and Gottlieb seemed to recognize the need to pivot in response to these external pressures. Manufacturers of these innovations often must take a different tack to reach the market, a path that has laid bare an outdated product approval process that’s in dire need of being revamped. Under Gottlieb’s direction, today’s FDA seemed to be up to the task: The agency has begun to match the innovations crossing its desk with some innovations of its own. As Gottlieb prepares to serve his final few weeks in office, let’s look at some of the ways that he has transformed the agency’s tech-related approach, and how his legacy will have long-lasting effects on pharma companies and how they do business.
Between Gottlieb, HHS Secretary Alex Azar and CMS Administrator Seema Verma, the U.S. Department of Health and Human Services has ushered in a progressive and agile way of thinking that matches today’s new conditions-even though I may not agree with all of the claims that they make or the actions they take. It’s interesting to take stock of the recent changes that they’ve each spearheaded and to look ahead at how the FDA, in particular, will prepare for the next wave of innovation, and whether its new chief will continue what Gottlieb started.
Pratap Khedkar is Managing Associate, ZS Associates.