The costs of running this huge site are paid for by ads. Please consider registering and becoming a Supporting Member for an ad-free experience. Thanks, ECF team.

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

Discussion in 'FDA Regulations' started by Rossum, Jun 21, 2019.

Tags:
Thread Status:
Not open for further replies.
Image has been removed.
URL has been removed.
Email address has been removed.
Media has been removed.
  1. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    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'
     
    • Informative Informative x 3
    • Useful Useful x 1
  2. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    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.
     
    • Like Like x 2
  3. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    And now Gottlieb has taken a position on Pfizer's board of directors.

    Guess who makes Chantix?
     
    • Winner x 3
    • Optimistic x 2
    • Like x 1
    • Agree x 1
    • Funny x 1
    • Informative x 1
  4. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    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.
     
    • Agree Agree x 3
    • Like Like x 1
    • Optimistic Optimistic x 1
  5. bombastinator

    bombastinator ECF Guru Verified Member ECF Veteran

    Sep 12, 2010
    MN USA
    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.
     
    • Like Like x 2
  6. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    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.
     
    • Agree Agree x 2
    • Informative Informative x 2
    • Like Like x 1
  7. somdcomputerguy

    somdcomputerguy vaper dedicato Verified Member ECF Veteran

    Supporting member
    BP doesn't make cures, they make customers..
     
    • Like Like x 3
    • Agree Agree x 1
    • Informative Informative x 1
  8. bombastinator

    bombastinator ECF Guru Verified Member ECF Veteran

    Sep 12, 2010
    MN USA
    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
     
    • Like Like x 1
  9. zoiDman

    zoiDman My -0^10 = Nothing at All* ECF Veteran

    Supporting member
    Apr 16, 2010
    So-Cal
    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?
     
    • Agree Agree x 1
  10. Izan

    Izan Vaping Master ECF Veteran

    Jul 1, 2012
    Mallorca, Spain
    About 6 months after the FDA bans it.
     
    • Funny Funny x 4
    • Winner Winner x 1
  11. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    [​IMG]

    :D
     
    • Funny Funny x 4
    • Winner Winner x 1
  12. stols001

    stols001 Mistress of the Dark Nicotinic Arts Verified Member ECF Veteran

    Supporting member
    May 30, 2017
    Tucson, AZ
    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
     
    • Like Like x 2
    • Agree Agree x 1
  13. bombastinator

    bombastinator ECF Guru Verified Member ECF Veteran

    Sep 12, 2010
    MN USA
    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
     
    • Like Like x 2
  14. zoiDman

    zoiDman My -0^10 = Nothing at All* ECF Veteran

    Supporting member
    Apr 16, 2010
    So-Cal
    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.
     
    • Agree Agree x 2
    • Like Like x 1
    • Winner Winner x 1
    • Informative Informative x 1
  15. mountaingal

    mountaingal Super Member Verified Member ECF Veteran

    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.
     
    • Agree Agree x 3
    • Like Like x 1
  16. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    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.
     
    • Like Like x 3
    • Informative Informative x 3
  17. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    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.
     
    • Like Like x 2
  18. Horselady154

    Horselady154 Ultra Member Verified Member ECF Veteran

    Jan 15, 2013
    United States
    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.
     
    • Agree Agree x 7
  19. stols001

    stols001 Mistress of the Dark Nicotinic Arts Verified Member ECF Veteran

    Supporting member
    May 30, 2017
    Tucson, AZ
    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.
     
    • Optimistic Optimistic x 1
  20. zoiDman

    zoiDman My -0^10 = Nothing at All* ECF Veteran

    Supporting member
    Apr 16, 2010
    So-Cal
    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.
     
    • Agree Agree x 4
    • Winner Winner x 2
    • Like Like x 1
    • Optimistic Optimistic x 1
Thread Status:
Not open for further replies.

Share This Page

  1. This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
    By continuing to use this site, you are consenting to our use of cookies.
    Dismiss Notice