FDA Juul is going to be in a hard spot to ever get their product approved

[Rossum]

So says former FDA head Scott Gottlieb.

• “They have so much historical youth use with their product,” says Scott Gottlieb. “I don’t know how juul gets through an application process.”
• The FDA proposed a 10-month deadline for e-cigarette makers to submit applications for government clearance to continue selling their products.
• The shortened deadline may prove to be tricky for juul, said Gottlieb, a physician, medical policy expert, and public health advocate.

More here on CNBC:
Ex-FDA chief Scott Gottlieb: 'Juul is going to be in a hard spot to ever get their product approved'

 

[sofarsogood]

So says former FDA head Scott Gottlieb.


More here on CNBC:
Ex-FDA chief Scott Gottlieb: 'Juul is going to be in a hard spot to ever get their product approved'

I have read recently that the US is something like 50% of the global consumer market but the last time I did the math the US has only 3% of the world's smokers. The question for American producers like JUUL or Evolv or the premium juice makers is, do they have an offshore market or can they develop one. (The FDA restrictions will only apply to selling in the US market, not manufacturing.) That's what I'd be thinking about if I were any of them.

 

[Rossum]

And now Gottlieb has taken a position on Pfizer's board of directors.

Guess who makes Chantix?

 

[sofarsogood]

And now Gottlieb has taken a position on Pfizer's board of directors.

Guess who makes Chantix?

Be sure that his director fee is a handsome one. What's sickening (literally and figuratively) is 75% of the problems that take people to the doctor's office are because of lifestyle and no pill cures any of them. There is no solution to so-called health care because the problem is health which pill companies and government can't fix.

 

[bombastinator]

And now Gottlieb has taken a position on Pfizer's board of directors.

Guess who makes Chantix?

The exact “why” of gottleib leaving the FDA is one of those unknowns. There are quite a few theories. My personal favorite is that HE was the one promised that 35% stake in JUUL and once he couldn’t get it there was no point in staying. Him taking a position in what is effectively the cigarette industry dovetails with that one.

 

[Rossum]

Him taking a position in what is effectively the cigarette industry dovetails with that one.

Pfizer may be many things, but it is not "effectively the cigarette industry". I know I pointed out that they make Chantix, but they had $53 billion in revenue last year. That's more than double Altria's, and Chantix looks to be barely more than 1% of that.

 

[somdcomputerguy]

There is no solution to so-called health care because the problem is health which pill companies and government can't fix.

BP doesn't make cures, they make customers..

 

[bombastinator]

Pfizer may be many things, but it is not "effectively the cigarette industry". I know I pointed out that they make Chantix, but they had $53 billion in revenue last year. That's more than double Altria's, and Chantix looks to be barely more than 1% of that.

Fair enough. It’s not a big enough product to move their company then. Do they also make patches though? Iirc those are gigantic cash cows for pharmaceutical companies

 

[zoiDman]

Pfizer may be many things, but it is not "effectively the cigarette industry". I know I pointed out that they make Chantix, but they had $53 billion in revenue last year. That's more than double Altria's, and Chantix looks to be barely more than 1% of that.

Just thinking out loud.

But if/when e-Cigarettes are Regulated back into the Stone Age, could the Fine Folks at Pfizer see another 500 Million in Revenue? Or perhaps... even More?

BTW - When does Chantix's Patent(s) run out?

 

[Izan]

Just thinking out loud.



BTW - When does Chantix's Patent(s) run out?

About 6 months after the FDA bans it.

 

[Rossum]

if/when e-Cigarettes are Regulated back into the Stone Age

 

[stols001]

What I saw was 2018 but it takes a while for generics to get up and going.

Given our lovely FDA allows for PLUS 25% and minus 20% for generics, this should be fun. I can't wait for like, to be 25% more homicidal.

I would advise anyone taking it to get the generic made by the drug company. At least it will be consistent (and we aren't even talking different fillers and release mechanisms yet.)

I actually thought Chantix had orphan drug status, meaning the only drug in its class for quitting smoking (and simultaneously wanting to die) but I guess I was wrong.

Scotty.. you are such a douche but okay. I sort of kind of miss your FDA reign in a way. It was whimsical and weird NOT terrifying. Come back. Chantix isn't for you. It's not for ANYONE.

Anns

 

[bombastinator]

Just thinking out loud.

But if/when e-Cigarettes are Regulated back into the Stone Age, could the Fine Folks at Pfizer see another 500 Million in Revenue? Or perhaps... even More?

BTW - When does Chantix's Patent(s) run out?

Not sure but data may be acquirable from following links here. Varenicline - Wikipedia
I didn’t know it was a black box drug. It’s got a lot of the same symptoms as tricyclics anti depressants

 

[zoiDman]

What I saw was 2018 but it takes a while for generics to get up and going.

Given our lovely FDA allows for PLUS 25% and minus 20% for generics, this should be fun. I can't wait for like, to be 25% more homicidal.

I would advise anyone taking it to get the generic made by the drug company. At least it will be consistent (and we aren't even talking different fillers and release mechanisms yet.)

I actually thought Chantix had orphan drug status, meaning the only drug in its class for quitting smoking (and simultaneously wanting to die) but I guess I was wrong.

Scotty.. you are such a douche but okay. I sort of kind of miss your FDA reign in a way. It was whimsical and weird NOT terrifying. Come back. Chantix isn't for you. It's not for ANYONE.

Anns

Not sure but data may be acquirable from following links here. Varenicline - Wikipedia
I didn’t know it was a black box drug. It’s got a lot of the same symptoms as tricyclics anti depressants

I believe that the Fine Folks at Pfizer will loose their Patent Protection for Chantix in Mid 2020. As well as Loosing a Handful of other Patents during the Next Administration.

Loss of Patent Protection to Drag Pfizer’s Top Line - Market Realist

Which made what happened with e-Cigarettes in this Administration such a Double Wham-ie.

I can see why the Fine Folks at Pfizer would want a Very Well Connected person like our friend Scott to be on the Payroll in the next few Years.

 

[mountaingal]

But what about the YOUTH? Almost every time I see regulations and bans they push the Youth point. It's bad for the Youth to puff ecig or regular cigs for sure. San Franciscos' latest ban had Youth as a basis to ban ecig sales or distribution. BUT, did they BAN cigarette sales? NO, because of the taxes they get from them. To me, it is all about the money.

 

[Bill Godshall]

Pfizer paid each of its Board members >$335,000 last year.

Meanwhile, Gottlieb claimed FDA wouldn't approve JUUL's PMTA (i.e. Gottlieb lobbied FDA to not approve JUUL's PMTA) in a Wall Street Journal op/ed the day before Pfizer announced Gottlieb joined its Board. But neither the Wall St. Journal nor Gottlieb ethically disclosed that Gottlieb joined Pfizer's board.

So when did Gottlieb begin discussions with Pfizer about joining its board?
- before Gottlieb's FDA issued a press release falsely claiming that vaping caused seizures?
- before Gottlieb proposed banning sales of flavored vapor products at retailers that allow youth entry?
- before Gottlieb falsely claimed that youth nicotine vaping was an epidemic?

Looks like Gottlieb is just another corrupt government official who abused his authority at FDA for his own selfish financial gain.

 

[sofarsogood]

Pfizer paid each of its Board members >$335,000 last year.

Meanwhile, Gottlieb claimed FDA wouldn't approve JUUL's PMTA (i.e. Gottlieb lobbied FDA to not approve JUUL's PMTA) in a Wall Street Journal op/ed the day before Pfizer announced Gottlieb joined its Board. But neither the Wall St. Journal nor Gottlieb ethically disclosed that Gottlieb joined Pfizer's board.

So when did Gottlieb begin discussions with Pfizer about joining its board?
- before Gottlieb's FDA issued a press release falsely claiming that vaping caused seizures?
- before Gottlieb proposed banning sales of flavored vapor products at retailers that allow youth entry?
- before Gottlieb falsely claimed that youth nicotine vaping was an epidemic?

Looks like Gottlieb is just another corrupt government official who abused his authority at FDA for his own selfish financial gain.

A question that interests me a lot is what Gottlieb's director fee will be. And I though there was some rule about not going to work for an entity you regulated until some years had passed, apparently not, silly me.

 

[Horselady154]

Yeah, maybe guys. Seems to me though that it was Gottlieb that postponed the Deeming crapola when he first got in office. And he's still arguing that products like Juul should be in a different bucket and treated differently than Mods. Say what you will, but I think our goose would have been cooked a couple of years ago had it not been for Gottlieb.

 

[stols001]

Oh the juul is gonna make it somehow. It does the impossible things (due to much money). The last vape I am worrying about is the JUUL.

Anna

I am discovering I do not want to get up and go to work. Sigh. Oh well it is Friday after all.

 

[zoiDman]

Yeah, maybe guys. Seems to me though that it was Gottlieb that postponed the Deeming crapola when he first got in office. And he's still arguing that products like Juul should be in a different bucket and treated differently than Mods. Say what you will, but I think our goose would have been cooked a couple of years ago had it not been for Gottlieb.

JMO...

But I think when Gottlieb first came to the FDA, that He did see e-Cigarettes for just what they are. Viable Harm Reduction to Smoking. And a Means to Improve Public Heath in the US.

But then the System started to Taint him. And Powers started to pull Him in different Directions. In the End, I Think he succumbed to them.

There is just So Much Money involved in which direction a FDA Policy might go. And it seemed that Gottlieb caught Flack from All Sides on a Issue that was Not Winnable. Or even, perhaps, manageable by the powers of the FDA.

Gottlieb, to Me, became a product of a Broken and Corrupt System. Just like Many Before him.