Bioregnum, People

Ned Sharpless is not playing with the FDA’s gold standard — any more than Scott Gottlieb did

Ned Sharpless got a chance to outline just what kind of acting FDA chief he’ll be in the wake of Scott Gottlieb’s departure from the agency. And aside from a more conservative selection of socks, he’s clearly planning to adopt the exact same fashions laid down by his predecessor.


In an all-hands-on-deck address to staffers, Sharpless promised to fit the Gottlieb mold perfectly, vowing to maintain the agency’s gold standard on drug approvals while doing what he can to keep the copycats coming to help tamp down on drug costs.

So let me reassure you, I am not planning any radical changes from what the FDA has been trying to accomplish.

Bioregnum Opinion Column by John Carroll

That’s a theme that will be music to the ears of the biopharma industry, which quickly swooned to Gottlieb’s energetic messages on speeding approvals whenever appropriate while holding the line on safety and efficacy standards. The future of the FDA proved to be a huge issue at the start of President Donald Trump’s term in office, as Trump entertained some libertarian notions that frightened the bejesus out of companies that clearly wanted a more receptive regulatory approach — without any regulatory anarchy that would destroy the value of an FDA OK.

Sharpless got right to it. His bottom line:

Necessarily, 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.

Now how to do that:  let me suggest two guiding principles.

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.

That message on continuity extends to the agency’s work hustling up less expensive knockoffs.

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.

What could be more reassuring to the industry, lawmakers and the public?

Interestingly, Gottlieb’s departure from the FDA was also marked by his insistence that the rank-and-file drug developers of the world needed to do more to adopt the reforms he had pushed, looking for faster, more efficient ways to develop drugs. The challenge for Sharpless will be to see if he continues that push as an industry trainer looking to get some out-of-shape developers up to speed with the new order. And that means urging regulators as well to get the lead out.

Scott Gottlieb

Continuity may sound like the exact right message here and now. But if that becomes a conservative approach to maintaining standards and traditions, pleasure may soon be replaced by an uneasy feeling that the FDA may once again become more of an obstacle and less of a partner. And that won’t be welcome.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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