More details and analysis of FDA's December 17 hearing - Page 2
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  1. #11
    Super Member ECF Veteran Linden's Avatar
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    I am just fascinated, listening to this. Initially I just skipped to the speakers that I wanted to hear (e-cig and harm reduction proponent) but I quickly realized that I wanted to listen to ALL of the testimony. Funny how the speakers who admit research funding from pharmaceutical companies have thinly veiled disdane for 'innovative' NRT products. They instead focus on making current products more readily available. They should be more forthright and disclose that they were sent to the hearing specifically by the pharma companies...because its obvious that is the case.
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    Very astute, Linden.

    Also did you notice that the pharmaceutical company speakers did not echo my recommendation that they increase the nicotine dosages in NRTs to make them more acceptable as THR alternative products? Instead, they recommend that people double up on using two different products at the same time, such as the patch and lozenges, or patch and gum. The end goal, we can assume would be to become abstinent from nicotine and continue to have 90% who do so relapse to smoking within the year.

    That way they double their revenue and continue to have repeat customers.

    Don't know why they haven't realized that using just one of their products indefinitely but NOT relapsing to smoking would earn them more money in the long run.
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    Quote Originally Posted by Vocalek View Post
    ...Instead, they recommend that people double up on using two different products at the same time, such as the patch and lozenges, or patch and gum...

    That way they double their revenue and continue to have repeat customers.
    Ah the good old, tried and trusted, 'Combination' Thereapy.
    Reminds me of an old UK TV series where the wearer of many Nicotine patches was chain smoking in an attempt to "top the patches up'


    Quote Originally Posted by Vocalek View Post
    Don't know why they haven't realized that using just one of their products indefinitely but NOT relapsing to smoking would earn them more money in the long run.
    Unfortunately not as much money as the cancer drugs they also supply - maybe I'm just being cynical.
    STUPIDITY = Doing the same thing and expecting different results.
    IDIOCY = Doing different things and expecting the same result

  4. #14
    Full Member TrueNews's Avatar
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    Can anyone help me identify the seating (left to right - 1 to 8) of the FDA panel.
    It would help me evaluate which sections of the FDA are the most aggressive (protectionist) in their questioning, when reviewing the video of the proceedings.

    FDA Panel (As listed by Bill Godshall)
    Grail Sipes - Senior Regulatory Counsel, Office of Regulatory Policy, FDA Center for Drug Evaluation and Research
    Sandra Queer - Deputy Director, Office of New Drugs, FDA Center for Drug Evaluation and Research
    Chistine Wing - Acting Deputy Director, Office of Drug Evaluation, FDA Center for Drug Evaluation and Research
    Bob Rappaport - Director, Division of Anesthesia, Analgesia and Addiction Products, FDA Center for Drug Evaluation and Research
    Lucillia Winchel - Medical Team Leader for Addiction Products, FDA Center for Drug Evaluation and Research
    Andrea Leonard Siegel - Director of Nonprescription Clincial Evaluation, FDA Center for Drug Evaluation and Research
    Corrine Huston - Senior Medical Advisor, FDA Center for Tobacco Products
    Eric Lindblom - Director of Policy, FDA Center for Tobacco Products
    Last edited by TrueNews; 12-22-2012 at 01:29 PM.
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    STUPIDITY = Doing the same thing and expecting different results.
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    I believe that Bill named them in the order they were seated. The first six work for the Center for Drug Evaluation and Research (CDER), which is the division of FDA that regulates treatments approved for smoking cessation, including the NRTs, plus bupropion (Zyban/Wellbutrin) and varenecline (Chantix/Champix).

    The last two people, on the far right work for the Center for Tobacco Products (CTP) that was created in response to requirements of the Family Smoking Prevention and Tobacco Control Act passed in 2009. The products regulated by the CTP are specified in Section 901 of the Act

    ‘(b) Applicability- This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.
    Full Text of H.R. 1256 (111th): Family Smoking Prevention and Tobacco Control Act - GovTrack.us

    Additional tobacco products not named in Sec. 901(b) are not covered under the regulatory requirements of the Tobacco Act unless and until the "the Secretary" (that would be the Secretary of Health and Human Services, Kathleen Sebelius) issues a regulation that deems the product to be subject to this chapter.

    Theoretically, the discussion was about products that are regulated under CDER, as discussed in ‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE' of the Tobacco Act.

    ‘(a) In General- The Secretary shall--

    ‘(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 506;

    ‘(2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and

    ‘(3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.
    I find it interesting that two members of the CTP participated on the panel. Apparently CTP thought there might be some crossover between the "innovative products" discussed in Sec. 918 (regulated by CDER) and the "modified risk tobacco products" (MRTPs) described in Sec. 911, regulated by the CTP.

    Sec. 918 has this to say about the report that was the topic of Monday's meeting:

    ‘(1) IN GENERAL- Not later than 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health--

    ‘(A) total abstinence from tobacco use;

    ‘(B) reductions in consumption of tobacco; and

    ‘(C) reductions in the harm associated with continued tobacco use
    Until now, the tobacco control industry has not entertained any method for smoking cessation other than "total abstinence from tobacco use." Items b and c in Sec. 918 and MRTPS (under Sec. 911) introduce a "tobacco harm reduction" concept into the mix.

    Given the fact that CTP issued regulatory guidance on the approval produces for MRTPs that requires research to start at the most basic level and proceed through testing that rivals anything a pharmaceutical company needs to go through to get a brand new drug approved, it appears that it will be many years (if ever) before a tobacco product can gain approval as an MRTP.

    Each company is required to put each of their products through the process, which increases both the time and the cost. So say that Camel snus achieved MRTP status, and RJR wanted to release a nearly identical product with a different name, the new product would have to start at step 1. Marlboro snus would be considered a completely different product and nothing learned by the research on Camel snus could be applied to Marlboro snus without repeating the entire testing process.

    The fact that the law specified a "fast track" process for the "innovative" products regulated by CDER makes regulation under Sec. 918 look more attractive (to me) at this point than being regulated by CTP under Sec. 911.
    Last edited by Vocalek; 12-22-2012 at 07:53 PM.
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    Well I hate to be one of those people Vocalek described but MONEY is what runs this country and the politicians in it.
    I do think that the people that put them in those positions will be listened to and I thank Vocalek, Bill Godshall, and all those that are trying to help this industry survive and be an honest, healthy one, and remain affordable. Without people like Vocalek and Bill Godshall the tobacco and pharmacy industry would have put and end to it all long ago for higher earnings. Let's just hope that for once the well being of people trumps the dollar.
    Again Thank you for all you do for us.
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    Merry Christmas to everyone!

    Very good posts here and thanks to everyone who stood up and testified.

    Call me a cynic in some ways then because when it comes to our US Government, I hold NO
    faith in them at all because I have seen all too well the "Selfish" reasoning in their law making.

    If it involves money in any form, they will do anything in their power to get it.
    And if it threatens their money, they will do even more to stop it.

    A very good example is the recent incident in Conn.

    They are STILL out to attempt further bans and controls on guns when it IS NOT the gun that
    is the issue. It is the issue that mentally incapable and criminal minded people will Always be able
    to get guns and don't need a "Waiting Period", don't need an ID or even a Birth Certificate.
    They can go to their nearest alley (perhaps the same one they get their drugs from) and to the
    nearest car trunk and buy any gun they want... including automatics and modified fully auto's.

    The "Nut Job" that did that in Conn - from what I have heard - even killed his own relative in order
    to get the guns she owned.

    The "Gun" is not the issue - if Guns kill people, then Forks "make" you fat, Lighters "make" you smoke,
    and Cars "make" you drive drunk!

    Fact is - Murder is outlawed but still happens... Theft is banned but still happens. Countries that
    outlawed guns still have their share of Crimes involving gun use. So what does banning and control
    do?
    Absolutely Nothing -- (to the criminals, that is).

    More Gun Control and Gun Bans will NOT stop a damn thing... the only thing it will do is make it even
    harder for Decent people to protect themselves. All the Gun ANTI's scream "No Guns, No Guns!" but
    when they get robbed - the first one they call is -- Someone with a Gun (e.g., Police, Military, etc.)

    Anyhow... I hope for everyone's sake that the FDA and US Government finally does the right thing on
    this one.
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    It would be very helpful if we can convince several thousand, several hundred, or even several dozen additional e-cigarette consumers to submit comments to the FDA on this docket before January 16 deadline pointing out that:
    - e-cigarettes helped you quit smoking and/or sharply reduce cigarette consumption,
    - your prior experience with NRT and/or Chantix,
    - urging FDA to not propose the "deeming" regulation because it would ban e-cigarettes, and would sharply increase the price and reduce accessibility of the products even if FDA exempted e-cigarettes from the most onerous provisions in Chapter IX.
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    Can this not be made a banner on ECF, like the one to help with cancer research (of which I'm participating because of it)??
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    Quote Originally Posted by Bill Godshall View Post
    It would be very helpful if we can convince several thousand, several hundred, or even several dozen additional e-cigarette consumers to submit comments to the FDA on this docket before January 16 deadline pointing out that:
    - e-cigarettes helped you quit smoking and/or sharply reduce cigarette consumption,
    - your prior experience with NRT and/or Chantix,
    - urging FDA to not propose the "deeming" regulation because it would ban e-cigarettes, and would sharply increase the price and reduce accessibility of the products even if FDA exempted e-cigarettes from the most onerous provisions in Chapter IX.

    I agree. This is very important as needs all the support it can get. I'll be on that list. Can you post a link please?
    OOPS I found it: http://www.regulations.gov/#!documen...12-N-1148-0001

    I did it.
    Your comment was submitted successfully!
    Last edited by 5cardstud; 12-22-2012 at 09:49 PM.
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