The king is dead; long live the king: Sharpless vows to continue Gottlieb era at FDA

  • August 22, 2019

Gottlieb, in fact, denied to reporters at the start of the year that he was leaving; however, a few short months later he announced he was doing exactly that (citing commuting times), and then preceded to have the world’s longest goodbye tour.  Fitting, I suppose, for a rock’n’roll FDA Commissioner.

Many in the bio Twitter sphere, along with President Donald Trump (which is the man who appointed him as FDA Commissioner), praised Gottlieb.  Some areas, though, namely the opioid crisis and the surge in an anti-vaxxer (anti-vaccination) movement, which has also seen a related spike in measles cases in the U.S., are still areas the FDA must get a grip on.

Sharpless, the former National Cancer Institute (NCI) Director, took over in April on an interim basis; however, said in his first major speech that:  “While my title may be Acting Commissioner, I assure you that I’m not acting as if this is a temporary or part-time job.  I plan to maintain FDA’s current course of action in every area and proceed full speed ahead…I promise you, for example, that we’ll continue our important and successful work to increase competition and reign in prescription drug costs through advances in our generic drug and biosimilars programs…And we’ll continue to do everything we can to make the development of new treatments and cures more efficient across our medical product centers, while ensuring that we maintain FDA’s gold standard of safety and efficacy.”

He adds that he is a “great admirer” of Gottlieb.  He went on:  “And let me dispel any misconceptions that the change in leadership reflects some desire of the president or the secretary for the FDA to go in a different direction from the Gottlieb era…That is not the case, Secretary Azar and the White House have been very clear with me that they have been impressed with the FDA’s efforts and would like to see this strong progress continue. Moreover, there is great support for the FDA’s mission in Congress. This support is positive and bipartisan…I’ve already experienced this firsthand through a number of calls with key legislators, and they’ve confirmed the high regard with which Congress holds the FDA. So, let me reassure you, I am not planning any radical changes from what the FDA has been trying to accomplish.”

He did add that there will be “course adjustments as new facts emerge,” but essentially:  “I feel I am walking into an organization on a good trajectory, and my main job is to figure out how keep that going…First, I believe our efforts should rely on and be guided by the science.  As a researcher, I am used to letting data drive my decision-making, and I know this has always been the approach at FDA.  Second, when wrangling with the complex issues that face the Agency, we will keep top of mind our mission of protecting and promoting public health, and what that means to the American public…So that’s what will steer my priorities as Acting Commissioner:  a commitment to science-based decision-making and prioritizing our efforts for the benefit of the public health.”

REFERENCE:  Fierce BioTech; 17 APR 2019; Ben Adams

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