FDA Trump picks former FDA official to head agency

[BuGlen]

From an AP news source:

Source: Trump picks former FDA official to head agency

Since leaving the FDA in 2007, Gottlieb has served as a board member or adviser to at least nine pharmaceutical or medical technology companies, according to his LinkedIn profile. Gottlieb is a consultant to GlaxoSmithKline's product investment board; a managing director at T.R. Winston & Company merchant bank, which specializes in health care; and a clinical assistant professor at New York University School of Medicine. He also is a policy adviser to the National Coalition for Cancer Survivorship.

 

[Painter_]

This could be very good for us. He is a fellow at the American Enterprise Institute. Which have publicly advocated to have the FDA ditch the regulation of e-cigarettes.

Let Me Google That

 

[retired1]

While he may be good in the long run for the e-cigarette industry, I don't hold out much hope for him being a champion for consumer safety.

 

[Grimwald]

Seems to be a bought and paid for BP shill.

 

[rwoodin]

Definitely a (pharma) company man. I did not know of his AEI fellowship position. That offers some hope of FDA scaling back scope of the regulations.

 

[DC2]

More on Gottlieb from an email I received today...

Paul Blair
Strategic Initiatives Director
Americans for Tax Reform

First, read this 2013 Forbes piece written by Gottlieb, "FDA's New Tobacco Scheme, and Its Legislative Underpinnings, May Go Up in Smoke." In the piece, he outlines the two dominant forces at play in the aftermath of the tobacco Control Act, which brought tobacco products under regulatory control of the FDA. Those two forces were the anti-tobacco crowd (activists) and current and future manufacturers of reduced risk products, like vapor products. In 2013, he concluded that "only one party can win."

To date, the activists have won. Absent immediate changes, the FDA will oversee the prohibition of vapor products in less than two years. But, if confirmed, Gottlieb can put a stop to that. The question becomes, will he? I've got good reasons to believe there's going to be a culture shift at the agency in a way that's more helpful than the status quo.

Second, a bit more on his background. Gottlieb served as Deputy Commissioner for Medical and Scientific Affairs at the FDA under President George W. Bush, is a clinical professor at NYU's School of Medicine and a venture partner at New Enterprise Associates, and is currently a resident fellow at the American Enterprise Institute (AEI).

As I often point out, they're as big a fans of the concept of harm reduction over at AEI as we are at ATR. A few pieces of commentary from AEI's Sally Satel:

• "What the US Should Learn from the UK's Wisdom on E-Cigarettes;"
• "Congress, Save E-Cigarettes from the FDA;"
• "How Vapers Can Help Smokers Quit;"

Where does this leave us? This nomination continues a significant opportunity for advancing a stated goal of the Trump administration: Big League regulatory reform. Gottlieb is a cancer survivor. He isn't some out-of-touch public health bureaucrat with little to no understanding of the real impact that bureaucracy can have on saving (or destroying) lives. I remain optimistic that this good, very good for the goals of the vapor industry and its millions of consumers who are living healthier lives as a result of market innovations.

 

[BuGlen]

It's his strong ties to the pharma industry that give me pause. I really don't want to trade one form of crony-capitalism for another form of crony-capitalism, as we won't make much progress overall. In the short term on vapor products, maybe, but the consequences overall could well end up nullifying any gains or moving farther in the wrong direction.

 

[Opinionated]

Personally, I'm not seeing how one person - even if he's favorable to the e cigarette industry - can do anything about deeming and how it affects us.

The reason I say this is that wasn't all this codified into law through congress? And therefore, wouldn't it have to be congress themselves to turn the tide?

 

[sofarsogood]

Personally, I'm not seeing how one person - even if he's favorable to the e cigarette industry - can do anything about deeming and how it affects us.

The reason I say this is that wasn't all this codified into law through congress? And therefore, wouldn't it have to be congress themselves to turn the tide?

It was the agency's discretion to decide vaping should be covered by the tobacco law so isn't it their discretion to change their minds after reviewing all the terrific science, blah blah blah.

 

[Katya]

It was the agency's discretion to decide vaping should be covered by the tobacco law

Not really. The FDA wanted to control (read: ban) e-cigs as a drug. In 2009, the agency stopped the shipments of electronic cigarettes made by Smoking Everywhere and NJOY. Smoking Everywhere (and later NJOY) sued, see Sottera vs. the FDA. Judge Leon ruled that the FDA can only regulate e-cigarettes as a tobacco product--unless they are being marketed as a cessation device.

 

[WorksForMe]

Not really. The FDA wanted to control (read: ban) e-cigs as a drug. In 2009, the agency stopped the shipments of electronic cigarettes made by Smoking Everywhere and NJOY. Smoking Everywhere (and later NJOY) sued, see Sottera vs. the FDA. Judge Leon ruled that the FDA can only regulate e-cigarettes as a tobacco product--unless they are being marketed as a cessation device.

That's true, but Judge Leon only suggested they regulate e-cigs as tobacco. He didn't say they had to do it. That was their decision. With new leadership they could roll back the deeming regs, or at least reduce their severity.

 

[DC2]

That's true, but Judge Leon only suggested they regulate e-cigs as tobacco. He didn't say they had to do it. That was their decision. With new leadership they could roll back the deeming regs, or at least reduce their severity.

Yes, this.

Many people believe that Judge Leon ruled that that is how they should be regulated.
As far as I could tell, it was just a suggestion.

It was a response to the FDA whining about not being able to regulate unless they got their way, and Judge Leon was telling them that they had other options if they were so damn concerned about it.

 

[wheelie]

You are going to win so much you are going to say "Mr. President all we do is win. We are sick of winning so much."