Because Scott Gottlieb is the new FDA Commissioner. He’s 44 years old and has one impressive resume.  He is a medic, investor, consultant and analyst, knows about vaping and worked for the FDA under President Bush.

He’s now got the big FDA gig; so what do we really know about him?

The Financials

Gottlieb’s main source of income was from his work as a managing director of T.R. Winston & Co., an investment bank that paid him $1.85 million from the beginning of 2016 to March of this year. The bank raised $4.7 million for Kure (an e-cigarette company) in June 2015, according to a press release at the time. Gottlieb, who joined the board that March, attended only one meeting, by telephone, Kure Chief Executive Officer Craig Brewer said in an email.”

If this one telephone call was his only involvement; how much does he really know about vaping? Well, it will be a fair amount, due to his bank raising $4.7 million. This type of money is only agreed upon after some serious homework into vaping and all things e cigarette related.

Gottlieb also earned roughly $400’000 from the Pharmaceutical industry over the last several years. This money has come from GSK, Pfizer, Daiischi Sankyo, Bristol-Meyers Squibb and Vertex Pharmaceuticals to name a few. He’s served on several Pharma company Boards, is well known for his analytical mind when it comes to health care policy and is regarded as an expert in this field. He also has a special interest in new medical technology.

A recent poll of 53 drug companies returned a 72% majority in favor of his appointment.

The Brief

Now he is the top man in the FDA, what exactly is his brief?  And will it include e-cigarettes?

 

We’ve all read what he said last week and had that flutter of hope in our hearts:

“Among these and many other opportunities, there’s probably no single intervention, or product we’re likely to create in the near future that can have as profound an impact on reducing illness and death from disease as our ability to increase the rate of decline in smoking.”

“We need to redouble efforts to help more smokers become tobacco-free. And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether. At all times, we must protect kids from the dangers of tobacco use.”

He has also said he would not:

“countenance a rise in adolescent smoking rates.’’

But he did not directly mention e cigarettes, he mentions reducing smoking. It looks as if he’s being very diplomatic here, and not rocking boats.  He is for harm reduction, and we think it is safe to assume that he understands the role vaping plays in this.

What he said in his first speech is congruent with his Forbes article from 2013, in which  he dares to suggest that the tobacco industry might be the very ones that help reduce the smoking rates, if they are allowed to move in that direction. He wrote:

“In short, would critics accept the proposition that ANY tobacco-based product could pose less risk, even if it were formulated into a non-smoked consumable?”

And he also questions the PMTA:

“Before this objection can be addressed, there’s a much more fundamental question at stake: Whether the regulatory scheme envisioned in the tobacco legislation will ever be able to operate.”

 

In the same article, Gottleib shows he is very aware that the FDA has been, in his words ‘infiltrated’. He wrote:

“The FDA is losing the widely-respected head of its Tobacco Center. Activists have managed to infiltrate the middle ranks of the agency’s center. And there will never be any love lost for the tobacco industry inside the agency proper. After all, FDA’s public-health orientation (and its physician ranks) imbues it with a pervasive antipathy of cigarettes and visceral concern for the health effects of smoking.”

He continues:

“Underneath this all, there’s a more basic issue: Whether it was ever reasonable to think that cigarette adversaries could make peace with tobacco firms through a regulatory compromise. The anti-tobacco researchers want to shut down cigarette makers. It’s really that simple. The cigarette makers, presumably, don’t want to go away. By many measures, it’s clear that some
tobacco firms want to transition into new products that carry fewer legal, business, and hopefully health risks.”

But let’s circle back to his brief, now we have had a glimpse of the politics he will be facing.

His Brief is to accelerate and cut red tape. Upon his inauguration, Rep. Greg Walden said:

“We are at a critical juncture in the effort to help accelerate the discovery, development, and delivery of new cures and treatments, and Scott will be an important ally in that journey,” 

Certainly, with his backgrounds and interest, he does sound like the man for the job, and he is acutely aware of the politics within the FDA.

Gottlieb will oversee the implementing of the 21st Century Cures Act, a complex directive requiring FDA to speed up and modernize its approval process for drugs and medical devices. The Cures Act is a US law that was enacted by the 114th United States Congress in December 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health.

ccording to one commentator, Gottleib may have his work cut out (if the following is true):

“Will Gottlieb have to follow Trump’s orders to repeal two regulations for every new one? Will he have to accept deep budget cuts that could affect his ability to implement the 21st Century Cures Act? And how far will Trump push in his stated goal to “slash restraints” at the FDA to speed up what the president has called a “slow and burdensome” process of drug approvals?”

Will the deeming regulations be one of the ones that is repealed?

We very much hope so, for all our sakes.

Gottlieb has said he is going to recuse himself from any previous financial involvements/conflicts of interest for a year. There is some uncertainty if that is a year from when he sold his investments, or a year from when he takes office. If the latter, this could mean he won’t be able to be deeply involved with the deeming regulations until May of next year, however, he will still be the Commissioner and will still be overseeing the FDA.

At his hearings before being confirmed for the role, he was non-committal when asked about e-liquid:

“I recognize there is a line here somewhere, and I don’t know where that line gets drawn.”

This sounds like a man being careful with his words, and as he says, waiting for the science.

On paper, Gottleib certainly looks like the man for the job.  He is astute, has written about the tobacco industry in a truthful manner, and he is aware of e cigarettes, enough to have invested in them. In now remains to be seen as to how much he can influence the FDA, and how much he can do while possibly recusing himself. But this is a positive time during this roller coaster of a regulatory ride.

It’s a positive time for vaping, and we can all do our bit to keep it that way – why not send Scott Gottlieb a tweet to let him know how much vaping means to you?

His Twitter handle is  @ScottGottliebMD and remember, he seems to be on our side – so please be polite.

Comments