WASHINGTON — Scott Gottlieb, the commissioner of the Food and Drug Administration, will resign in one month, the Trump administration announced Tuesday.

Gottlieb had served as FDA chief since May 2017.

The 46-year-old doctor was among President Trump’s most popular appointees. While some Democrats initially questioned his ties to conservative groups and the pharmaceutical industry during his confirmation, Gottlieb quickly won respect from lawmakers of both parties.

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In Gottlieb’s resignation letter, which the FDA shared with STAT, the commissioner did not explain why he plans to leave the agency.

Scott Gottlieb's resignation letter

“Over the past 23 months, I’ve been privileged to work with an outstanding team at the Food and Drug Administration, and to collaborate with the professional staff on implementation of many meaningful incentives that have advanced the public health,” Gottlieb wrote. “I’m fortunate for the opportunity that the President of the United States afforded me to lead this outstanding team, at this time, in this period of wonderful scientific advances.”

In a tweet, Trump credited Gottlieb with helping to lower prescription drug prices and working toward the approval of generic drugs.

During Gottlieb’s tenure, the FDA repeatedly broke its annual records for approving generic drugs. As the Trump administration increasingly focused on the high cost of prescription drugs, Gottlieb emerged alongside health secretary Alex Azar as a powerful voice within the administration.

Like Trump and Azar, Gottlieb often took an aggressive tone with drug manufacturers, decrying their “shenanigans” and publicly shaming companies that tried to prevent competitors from bringing new drugs to market.

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Gottlieb also took a lead role in addressing the opioid crisis, taking steps to encourage use of medication-assisted treatment for addiction and cracking down on illicit internet drug sale.

Gottlieb also took on the issue of tobacco use perhaps more than any FDA commissioner since David Kessler, who led the effort in 1990s for FDA to begin regulating tobacco. Gottlieb’s effort to restrict flavored tobacco, including menthol, ruffled feathers among Republican lawmakers, most notably Sen. Richard Burr (R-N.C). The agency has proposed restricting flavored nicotine products to prevent teenage use, and banning menthol cigarettes.

Rumors about Gottlieb’s departure had swirled for months. In January, he wrote on Twitter: “I want to be very clear — I’m not leaving. We’ve got a lot important policy we’ll advance this year.”

Azar said in a statement that he would “personally miss working” alongside Gottlieb.

“He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation,” he added.

The news was first reported by The Washington Post.

Matt Herper contributed reporting. 

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  • I almost feel pity for this guy. He is in cahrge of the mad hatters tea party. The FDA is no longer functioning to benefit public health. Years of underfunding, and removal of certian targeted postitions have rendered it uselless. Gottlieb was not allowed to speak of industry influence, marketing and propaganda, that is ruining the health of Americans. 24 million Americans died last year becuase of lack of access to healthcare. It must be really hard to function, when the facts are no longer appropriate.

    He will get a big industry position, a huge salary that so many Americans have already paid for with their lives.

  • It seems that ‘Doctor’ Hilton and Drug Czar both have an axe to grind vis-a-vis Scott Gottlieb.
    Which probably means they are both Pharma dudes with a very one-sided view of FDA efforts to protect and promote the public health, and probably also indicates that Dr. Gottlieb has been doing an excellent job whilst in post.
    His departure from the FDA will be the most grevious loss to bear by far among the many exiteers from this administration.

    • Gottlieb is more politician than physician, into hedge funds and promoting medical toys for big pharma, working as a policy wonk for conservative propaganda tanks, then got a job at FDA as a GS working in very obscure jobs till his appointment. Obscure? Biological warfare defense planning is rather obscure, especially as CDC and DOD both have that mission on their plates.

      Vaping has been around since 2004. So far neither Obamas’ nor Trump’s administrations have lifted a finger to regulate the industry to protect Public Health despite a Congressional mandate. The UK encourages doctors to recommend vaping as a safer alternative to tobacco. The US actively discourages doctors from doing that despite huge studies (meta analyses of groups of studies) demonstrating safety. When it comes to Big Tobacco, FDA treats them much like it treats Big Pharma and Big Oil – all-talk-no-action. After he cleans out his desk, notbody will know Gottlieb had even been there. Watch where he goes from here. The swamp calls.

      The only legacy Gottlieb can take with him is that he has not been accused of malfeasance or unethical behavior – yet anyway.

    • The reaction of Biotech stocks on the stock market clearly underscores the positive influence Dr. Gottlieb has, which effectively counters the one-sided views of Dr. Hilton and Drug Czar. Gottlieb’s professional and pro-active personality drew respect, a rock in this chaotic US Administration. It is likely that he re-appears where public health improvements can be accomplished with fewer strings attached, and in shorter time.

  • So, he said a lot of things without actually implementing or changing anything.
    And approving a lot of drugs is not really a meaningful metric. Indeed, I can name at least a few, of what I call, FDA validated scams.
    I guess, these days, as long as you don’t make disasters you qualify as been “great”

  • To counter Mr. Hilton’s comments : the expectation that an FDA Commissioner can “fix” the US public health system in a mere 22 months on the job seems a bit far-fetched, even for a star such as Dr. Gottlieb. His plate was quite loaded, and to belittle this in name-games is not called for.

    • The anonymous Krista F has demoted me from Dr. to Mr. perhaps as a means of invalidating my remarks, or just a good ole fashion Alt-right insult.

      As my post mentioned, leading Public Health is the Surgeon General’s leadership role; not the FDA Commissioner. FDA’s primary mission is to ensure that pharmaceuticals are safe and effective, and by recent Congressional law, to regulate tobacco products and nicotine – which – as I mentioned, he has done woefully little to the delight of Big Tobacco.

      It is the mission of the White House Office of National Drug Control Policy to lead drug interdiction and addiction treatment policy. It is not FDA’s mission to promote a specific pharmacological treatment for addiction above all other methods and medications that are equally effective. That is the mission of the Substance Abuse and Mental Health Services Administration.

      So maybe had Gottlieb not spent so much time boundary spanning, and focused on his job, he might have left a legacy other than – “Well, he coulda been worse.”

  • more to come on this, I suspect. It doesn’t pass the smell test – feels like he’s being forced out.
    I was highly skeptical when he was nominated and approved. However he has far and away been the best appointment of this misbegotten administration. He has been outstanding, and his resignation is to the detriment of US public health.

    • It is a sad commentary that a Dr. Doolittle is praised for not being Dr. Dooworse. Public health did not thrive under Dr. Gottlieb, it just did not die on his watch.

    • Agree with tw. One sure has to wonder if there is not more behind it.

      Scott Gottlieb, along with David Shulkin and unlike almost all other Trump appointees, was actually qualified, hard-working, and devoted to the mission of his agency. Neither might see it exactly the way I (who am no Republican) do, but both were serious, dedicated individuals.

      It’s devastating and tragic to see qualified individuals leave who will not likely be replaced with anyone else remotely similar, but (most likely) by a typical Trump-appointee hack who is ruining the government.

  • The fact that stocks of tobacco and vape companies are up since the announcement of Scott Gottlieb’s resignation proves Mr. Thomas F Hilton, PhD dead-wrong. Harsh one-sided criticism like his possibly contributed to the FDA Commissioner’s resignation decision. Dr. Gottlieb should be commended for what he accomplished in a rather short time: stepped-up generics approvals, thumb-screws on over-charging drug companies, more new competitive drugs, and yes the FDA siding with increased reduction of nicotine and e-cig. I’d say that Dr. Gottlieb is a highly accomplished individual. And if there is no link with the Purdue case, then I wish Dr. Gottlieb all the best.

    • I do not take seriously criticism from those too cowardly to use their full (or genuine) names.

  • This article is pure fluff. Dealing with the treatment of addiction is not the FDA Commissioner’s job. It is the Surgeon General’s job (who is that again?). Gottlieb did nothing substantive or substantial to deal with opioid or tobacco addiction besides give some speeches and interviews and issue one useless token regulation to ban kool-aid flavoring of eCigarettes – as if that is why teens vape. As far as opioids are concerned, promoting agonist maintenance therapy is good for Big Pharma’s bottom line. Abstinence recovery loses Big Pharma customers whereas buprenorphine and methadone add to their customer base.

    What Gottlieb did NOT do was establish manufacturing standards for nicotine delivery devices when research has shown that some imports leach toxins that might be more deadly than tobacco smoking.

    Gottlieb did NOT regulate the amount of nicotine permitted in eCig cartridges which could be 3 times the strength of tobacco products and thus more quickly addicting users.

    Gottlieb did NOT commission research into the safety of heat-not-burn tobacco products which might be more toxic than smoked cigarettes.

    If anything, Gottlieb would appear to be derelict in his duty (there’s something new in the Administration); not a champion of it.

    • Dr Hilton, Thanks for highlighting work still to be done. However, that need not devalue the great work Dr Gottlieb did in < 2 years. He was awarded by the AMA for his contributions in Wash DC this February 2019. We congratulate you, too, on your work w the NIH Health Services & Economics sections, your insights on opiates, and after your tour in the US Navy. Any COI's or comments on Purdue pharmaceuticals would be welcome.

    • Dr. Hilton – the US government’s definition of public health is nothing more than basic advice – wash your hands, cover your mouth when coughing/sneezing, stay at home when under the weather so as to protect the general public. That’s it – oh wait – the department’s funding has been axed – perhaps that’s the reason for the vacuum that exists regarding health care?

    • I agree Doctor!

      What is kind of disturbing is that the FDA did not recognize how the vape industry was marketing these products to kids as a wellness product. The same tactic is being used by the marijuana industry.

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