FDA

With Trump’s new FDA commish nominee looming, industry execs are keeping their fingers crossed for Scott Gottlieb

Scott Gottlieb

Last week President Trump said he was just days away from announcing an absolutely “fantastic” new FDA commissioner. One who would cut up to 80% of the regulations around drug development, blazing a shorter path to an approval. One who would get experimental meds to dying patients, overhauling timelines and slashing development budgets.

By and large, the message has spurred more than a little trepidation in the industry that the president, who has earned a reputation for shooting first and asking questions later, was going to radically change the approval process at the FDA. And that might indicate that libertarian “seasteader” Jim O’Neill — who has famously said that drugs should be approved on safety alone — has the inside track with the new president.

But he’s not the industry’s first choice. That distinction appears to be reserved almost entirely for Scott Gottlieb, the former deputy commissioner at the FDA under George W. Bush with a reputation as a staunch conservative with no known appetite for tossing grenades into the regulatory underbrush.

Mizuho Securities USA ran a quick survey of 53 drug companies asking them which of the four candidates mentioned so far in the media — Gottlieb, O’Neill, Balaji Srinivasan and Joseph Gulfo — would get their vote.

Seventy-two percent picked Gottlieb. The rest were also rans. O’Neill got a handful of votes at 8%, with Gulfo at 9% and Srinivasan at a mere 2%. (Gulfo has promoted his own candidacy without any independent confirmation from the Trump administration that he’s ever been a serious candidate or been within 100 feet of the new president.)

In his weekly roundup on Friday, Baird’s Brian Skorney came to the same conclusion without any polling. He wrote: “We believe industry and investor support is overwhelmingly in favor of Scott Gottlieb.”

“He leans right, he’s got experience in the agency, he’s got the M.D. credential, and he’s outspoken,” Michael Gaba, federal policy leader of law firm Holland & Knight’s national Healthcare & Life Sciences Team, told Reuters recently.

I asked Gaba to elaborate on that. And he sent me this:

When it comes to the FDA, biopharma, and regulated industry as a whole, puts a premium on predictability, speed to market, and the ability to make differentiating claims in the marketplace about their products’ effectiveness to treat and mitigate disease.  Safety is the given once a product makes it through the FDA, and by itself doesn’t distinguish products in the marketplace.  Among the FDA commissioner candidates we’ve read about, Dr. Gottlieb is well known to industry and has the requisite experience and talent to reform and streamline the FDA approval process.

The theme among the other candidates appears to be to speed products to market by limiting the agency’s role to evaluating safety only.  Not only would this dynamic be challenging to industry, providers and patients, it would require a statutory change to the FDCA – and we all know that the legislative process itself can be very messy and unpredictable.

Gottlieb’s nomination would continue a longstanding tradition of naming a trained physician for the top job at the FDA. As a resident fellow at the American Enterprise Institute, he’s kept the heat on Obamacare through a series of op-eds in high profile publications like the Wall Street Journal. As a venture partner at New Enterprise Associates he’s a board member at MedAvante, which markets software for analyzing clinical trial data. And he’s an advisor to GlaxoSmithKline, which has shown no appetite for radical change in the way developers prove a drug works.

It’s the kind of resume that would indicate a sympathy for continuing to evolve regulations to speed development, but without any appetite for playing revolutionary.

Of course, that’s one reason why he may not get the job. Trump has gleefully named new cabinet members based on their hostility to the agencies they’ll be running and the regulations they’ve been involved in creating. And his executive order demanding the elimination of two rules for every new one underscores his commitment to eliminating hundreds of pages of regs for every one that survives.


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RAPS Regulatory Convergence 2017