More details and analysis of FDA's December 17 hearing
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    Default More details and analysis of FDA's December 17 hearing

    FDA Hearing December 17, 2012 - FDA Panel
    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

    Testimony
    1 of 4 (FDA's Grail Sipes 0:00-0:08, Gregory Conley 0:08-0:15, Lorie McClung 0:15-0:23, Carl Phillips 0:23-0:39, Linc Williams 0:40-1:00, CASAA's Elaine Keller 1:00-1:14, SRNT's Jonathan Foulds 1:14-1:47)
    https://collaboration.fda.gov/p98191...&pbMode=normal

    2 of 4 (ATTUD's Michael Steinberg 0.00-0.10, CTFK's Danny McGoldrick 0.11-0.17, ACS' Angela Jones 0.18-0.24, Legacy's David Abrams 0.24-1.10, Smokefree Pennsylvania's Bill Godshall 1:11-1:28, TCLC's Kathleen Dachille 1:28-1:37)
    https://collaboration.fda.gov/p95861...&pbMode=normal

    3 of 4 (ACSH's Gil Ross 0:00-0:11, Scott Ballin 0:12-0:22, Altria's James Dillard 0:22-0:37, Johnson & Johnson's James Walmsley 0:38-1:09, GlaxoSmithKline's Howard Marsh 1:09-1:38, What A Smoke's Mark Anton 1:38-1:47)
    https://collaboration.fda.gov/p36279...&pbMode=normal

    4 of 4 (Blue Mist Vaping's Robert Jack 0:00-0:08, American E-Liquid Manufacturing Standards Association's Lou Ritter 0:08-0:32, Legacy's David Abrams 0:33-0:36)
    https://collaboration.fda.gov/p20988...&pbMode=normal

    As 13 tobacco harm reduction advocates (including 7 e-cigarette consumers and 2 vendors) educated the FDA panel about THR and THR products, 2 drug company representatives and 5 or 6 drug industry funded groups urged the FDA to fast track approval for NRT and other drug industry products.

    While the FDA panelists either didn't ask any questions or asked "gotcha" questions to THR advocates in an attempt to trick, embarrass and/or discredit them, those same FDA panelists asked many friendly "softball" questions to drug industry representatives and drug industry funded promoters of drug industry products.


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    Thank you so much for this post Bill. And my undying thanks and gratitude to everyone who testified.

    I'm starting to watch the entire series, but it will take a bit of time to fully appreciate it and digest it.
    I do have one fear in the back of my head while watching, and that is the fear that the recordings will not be archived past the 30 day (?) FDA archival limit. Most worrisome is the horrible closed caption transcription, and the thought that a genuine transcript of the comments and questions may not be available to Congress.

    Is the testimony archived anyplace other than on the FDA site? If not, does anyone have suggestions on how to best save it using a Linux based PC?

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    Linc Williams (maker of the film "We are Vapers") videotaped the entire hearing. Recordings will be made available via the CASAA site, once Linc has the chance to edit the raw footage.
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    Quote Originally Posted by Vocalek View Post
    Linc Williams (maker of the film "We are Vapers") videotaped the entire hearing. Recordings will be made available via the CASAA site, once Linc has the chance to edit the raw footage.
    Thanks for the info. (sigh of relief )
    I can just imagine needing to clarify something for my legislators many months from now.

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    My assessment is that THR and e-cigarette advocates rained all over FDA's planned parade for NRT and the drug industry at Monday's hearing.

    THR advocates outnumbered drug industry funded folks 2 to 1, and testimonies by THR advocates were far superior to those of drug industry funded folks.

    It was pretty clear to me that 6 of the 8 FDA panelists (i.e. those with the FDA's drug office) had very little knowledge or understanding of THR, e-cigarettes or smokeless tobacco, the comparable health risks of different tobacco/nicotine products, or the many false and misleading claims that have been made by FDA, CDC, US SG, and other DHHS agencies about the risks of smokefree alternatives.

    In a nutshell, we gave those FDA staff a sorely needed education about these important issues.

    And since the intended purpose of FDA's hearing was NRT and other drug industry smoking cessation products, we basically turned their hearing into an educational session about e-cigarettes, smokeless tobacco products and THR.

    We also sent the FDA a message that if/when they propose a deeming regulation to apply Chapter IX of the FSPTCA to e-cigarettes, we'll be back in far greater numbers.
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    Here is the testimony I gave at Monday's FDA hearing (which is slightly different than what I sent FDA on December 10).

    Food and Drug Administration
    [Docket No. FDA-2012-N-1148]

    Public Hearing: FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence

    December 17, 2012

    Testimony
    by
    William T. Godshall, MPH
    Executive Director
    Smokefree Pennsylvania
    1926 Monongahela Avenue
    Pittsburgh, PA 15218
    412-351-5880
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    [email protected]

    I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to ban smoking in workplaces, reduce tobacco marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that smokefree tobacco/ nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable to smokers. In 2007, I convinced Sen. Mike Enzi to amend to FSPTCA to require graphic warnings on cigarette packs. And two decades ago, we urged the FDA to approve NRT for OTC sales.

    For disclosure, neither I nor Smokefree Pennsylvania have ever received any funding from any tobacco, drug or electronic cigarette company or trade association.

    I’m here to once again urge the FDA to stop protecting cigarettes from market competition by far less hazardous smokefree alternatives, to correct or clarify FDA’s many inaccurate and misleading claims about low risk smokefree tobacco and nicotine alternatives, and to keep all smokefree alternatives legal and affordable for smokers.

    >99% of all tobacco attributable mortality and health care costs in the US are caused by repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. Epidemiological evidence indicates that cigarettes are at least 100 times more hazardous than smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco, electronic cigarettes and NRT products.

    While quitting all tobacco/nicotine use is an effective way for smokers to improve their health, switching to smokefree tobacco/nicotine products reduces smoker’s health risks nearly as much as quitting all tobacco/nicotine use. Survey and sales data indicate that more than a million smokers have quit smoking by switching to smokeless tobacco products, that several million smokers have switched to smokefree e-cigarettes in the past several years, and that many smokers use NRT products as temporary or long term alternatives to cigarettes.

    Since there have been many reports of suicide, suicidal thoughts, violence and adverse cardiovascular events associated with Chantix, I urge the FDA to consider removing Chantix from the market, or at least require additional warnings to better inform consumers of its risks. I also urge the FDA to NOT fast-track the approval process for any new drug for treating “tobacco dependence”.

    Although FDA has approved many NRT products to treat tobacco dependence, NRT products have had a 95+% failure rate for treating tobacco dependence and for smoking cessation.

    Therefore, I urge the FDA to disapprove NRT products as treatments for tobacco dependence, to not approve NRT products as smoking cessation aids unless clinical trials find a 20% or higher success rate, or to at least require manufacturers to notify consumers of the six and twelve month success rates the product was found to have for both smoking cessation and for achieving nicotine abstinence.

    But since NRT products are far less hazardous alternatives to cigarettes, and since most NRT products are consumed for “off label” use as temporary or long term substitutes for cigarettes, the FDA should approve all NRT products as temporary and long term harm reduction alternatives to cigarettes.

    The FDA should adopt RJ Reynolds citizen petition to replace the intentionally deceptive “not a safe alternative” warning on smokeless tobacco products with one that informs consumers that cigarettes are far more hazardous, and should propose a similar warning for cigarette packs since smokers are at greatest risk.

    Warning labels on NRT products should also state that the product is far less hazardous alternative to cigarettes, and should encourage (instead of discourage) smokers to continue using NRT as long as they continue to smoke.

    If FDA implements these regulatory changes, manufacturers of e-cigarettes, dissolvables, smokeless tobacco products and other new smokefree alternatives might consider applying to the FDA to market their products as NRT tobacco harm reduction alternatives.

    NRT manufacturers should consider more aggressively marketing their products to smokers. In contrast to most NRT products that are sold in $40+ packages at pharmacies, RJ Reynolds’ Niconovum is test marketing Zonnic nicotine gum in $3 ten-packs at convenience stores throughout Des Moines, IA.

    Regardless of regulatory changes for NRT products, the FDA should never again ban or impose unwarranted or unreasonable regulations on e-cigarettes, dissolvables, or smokeless tobacco products because these products have nearly identical health/safety risk/benefit profiles as NRT products.

    In 2009, in an attempt to justify its unwarranted and unlawful import ban on e-cigarettes, then FDA Deputy Commissioner Josh Sharfstein misrepresented the agency’s laboratory test findings on e-cigarettes to scare the public, and to falsely claim the products were target marketed to youth.

    But even after the FDA concurred with Judge Leon’s ruling prohibiting FDA from banning e-cigarettes as unapproved drugs, the FDA has refused to correct or clarify its inaccurate and misleading claims about e-cigarettes. Even worse, the agency has issued even more misleading claims about e-cigarettes.

    And yet, e-cigarette sales continue to skyrocket and should surpass NRT sales next year, whose sales have remained stagnant at $1 billion annually for the past decade.

    The FDA has repeatedly stated its intent to propose a “deeming” regulation to apply Chapter IX of the FSPTCA to e-cigarettes. But Sections 905 and 910 would ban all e-cigarettes, and other provisions of Chapter IX would also decimate the e-cigarette industry, protect cigarette markets and otherwise threaten public health. The FDA should NOT propose or approve any regulation that would deny cigarette smokers legal or affordable access to less hazardous smokefree alternatives.

    The FDA has also denied the growing body of scientific evidence and consensus among experts by falsely stating on a webpage about MRTP titled Health Fraud “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."

    Many other FDA and DHHS websites also contain false and misleading fear mongering claims that exaggerate the risks and deny the benefits of smokeless tobacco products for smokers.

    One week after FDA’s TPSAC issued a report that acknowledged dissolvable tobacco products are less hazardous than cigarettes and can reduce risks of smoking, the FDA issued a draft guidance for MRTP Applications that denied the scientific evidence, and would require smokeless tobacco companies to spend tens of millions of dollars on unnecessary studies before the FDA might allow the company to truthfully inform smokers that a smokeless product is less hazardous than cigarettes.

    Smokers have a human right to truthful health information and legal access to less hazardous alternatives, and the FDA has an ethical duty to inform smokers that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes, and to keep all less hazardous alternatives legal and affordable for smokers.

    Instead of wasting public dollars defrauding the public and abusing its authority and the rights of tobacco consumers by demonizing and campaigning against all tobacco use, the FDA, CDC, US SG and other DHHS agencies should focus on reducing the leading cause of disease, disability and death, which is cigarette consumption and daily smoking, not tobacco use.

    Abstinence-only prohibition policies and propaganda didn’t work for alcohol, ......... or sex, and they don’t work for tobacco either.

    Please note that the four previous speakers oppose all tobacco use, and urged the FDA to ban e-cigarettes.
    Last edited by Bill Godshall; 12-21-2012 at 05:04 PM.
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    Default About the FDA's December 17 hearing

    Full Title:

    FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing

    Background:

    Products that contain nicotine are regulated by two different divisions of the U.S. Food and Drug Administration. The Center for Drug Evaluation and Research (CDER) regulates “smoking cessation” products such as pharmaceutical nicotine patches, gum, lozenges, oral inhalers, and nasal inhalers. Collectively, these are referred to as “NRTs” which stands for Nicotine Replacement Therapies. CDER also regulates the drugs varenicline (Chantix / Champix) and the antidepressant bupropion (Zyban / Wellbutrin) which have been approved for treatment of “tobacco dependence.”

    After the 2009 passage of the Family Smoking Prevention and Tobacco Control Act (Tobacco Act), the FDA started a new division, the Center for Tobacco Products, to regulate the two types of tobacco products covered under the Tobacco Act: Cigarettes and smokeless tobacco. Products such as pipe tobacco, cigars, e-cigarettes, snus, and dissolvables are not currently covered under the Tobacco Act, but there is a clause that permits the Secretary of Health and Human Services (who rules over all the health-related agencies such as the FDA and CDC) to issue a “deeming regulation” to bring other products under the regulatory control of the Tobacco Act.

    I mention e-cigarettes among the list of tobacco products because after two companies sued the FDA in 2009 over the Agencies attempts to ban the sale of e-cigarettes by “regulating” them under the Food, Drug, and Cosmetics Act as pharmaceutical products that are regulated under the CDER division. The Judge in that case ruled that e-cigarettes are not being used to treat a disease, that “intended use” governed whether a product is a drug or something else (food, supplement, etc.), and that the FDA could not regulate e-cigarettes as a drug. In his opinion document, the judge suggested that if the products needed to be regulated to protect public safety, the FDA might want to do so under the (then) newly passed Tobacco Control Act. He pointed out a loophole in the definition of tobacco products: “products made of or derived from tobacco.” Since nicotine is derived from tobacco, that definition would provide the basis.

    Section 918 of the Tobacco Act addresses the products regulated by CDER. Tobacco products are addressed by the remainder of the Tobacco Act. Section 918 requires the FDA to submit a report examining "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 the following three goals: (1) total abstinence from tobacco use, (2) reductions in consumption of tobacco, and (3) reductions in the harm associated with continued tobacco use."

    Currently, the theory under which CDER regulates “smoking cessation” products is that “tobacco use” represents an addiction to the chemical nicotine, and the only way to treat any addiction is to require the subject to become 100% abstinent from the chemical. The only treatments that contain nicotine are designed to provide much lower levels of nicotine that the typical smoker ingests, and to wean the subject down and off nicotine. Therefore the ideas suggested in items (2) and (3) of the required report are of a different nature than the current approach.

    The purpose of the hearing was to provide the FDA with enough information to produce the Report to Congress required by Section 918 of the Tobacco Act.

    My Observations:

    In my presentation, I discussed the fact that some smokers will never be able to give up all use of nicotine—especially those self-medicating underlying conditions that create cognitive deficits and/or mood impairment. I pointed out that the prescription medications used to treat these conditions did not work for everyone and can be expensive (up to $400 / month), especially in view of the fact that smokers tend to have lower incomes. Replacing the hazardous act of smoking with nicotine from a smoke-free alternative is referred to as Tobacco Harm Reduction, and this practice has proven to help a larger percentage of people to escape from smoking that the nicotine abstinence approach.

    I described the three categories of smoke-free alternatives that The Consumer Advocates for Smoke-free Alternatives Association (CASAA) supports: Pharmaceutical Nicotine (NRTs), smokeless tobacco products, and electronic nicotine vaporizers (“e-cigarettes”). I cautioned that to be more effective as a replacement that smokers would find acceptable, the NRTs needed to come in higher nicotine doses and to be approved for indefinite use.

    I also stated that smoking cessation (using the literal interpretation of the phrase) was more important to health than worrying about moralistic issues of addiction. I pointed out that the research on the effects of smokers in Sweden switching to snus showed that the risks of cancer and heart disease are greatly reduced.

    Section 918 includes a provision to “fast track” approval of innovative products that might increase the rates of smoking cessation. I commented that Section 911 of the Tobacco Act talks about approval of “Modified Risk Tobacco Products” (MRTP) and that the Center for Tobacco Products (CTP) had issued regulatory guidance on the MRTP approval process that described a process that would cost millions and take years.

    “If CDER can implement a fast track process for previously known, unproven, innovative smoking cessation pharmaceutical products, the Center for Tobacco Products should be implementing a fast-track “modified risk tobacco product” approval process for the smokeless tobacco products that have a proven beneficial effect at the population level,” I stated, “Research on products that are proven to be less hazardous at the population level should not be forced to start at the most basic level. How many lives will be lost before the FDA tells smokers the truth?”

    The panel’s two questions to me were 1) What is the source of the statistic that 62% of smokers earn less than $36,000 and 2) What about increased risk of pancreatic cancer in snus users?

    I had to admit that I had not made a note of the source after I tracked down the statistic on the internet. Regarding the pancreatic cancer risk, I stated that there were two studies on this, showing opposite results, and the writer had arbitrarily selected the study that showed an increased risk. I also pointed out that the absolute risk was very small, in the neighborhood of 4 extra cases per 100,000.

    Luckily, we can submit written comments up through January 16, 2013. I plan to try to fill in the knowledge gaps for the panel, not just from my presentation but also from other issues that arose during the hearing. I would include copies of research that shows the safety profile of switching to snus, as well as a bibliography of research on e-cigarettes. I will also comment on the fact that the speakers from Johnson and Johnson and GlaxoSmithKline recommended that people use multiple products simultaneously, but said nothing about increasing nicotine dosages in products. I will point out that using multiple products helps the bottom line of the pharmaceutical company, but that higher doses would save the former smoker money required double-up on products to prevent relapse.

    Another thing I plan to include in my written comment is that the EU’s recommendations for e-cigarettes will destroy the effectiveness of the products to serve as a replacement for smoking. Many smokers will not be able to replace all their smoked cigarettes with vapor if the doses are reduce to 2 to 4 mg. If they try to vaporize more liquid to reach their required nicotine intake, that would raise the cost by a factor of up to 6 times, making the products more expensive than continuing to smoke. (That happened to me in the 1980s when the U.S. Surgeon General suggested that smokers that can’t quit switched to low tar / low nicotine cigarettes. I had been smoking a pack a day for 20 years. A few months after switching, I noticed that I had increased my smoking to 2-1/2 packs a day. The take-away message here is that nicotine users self-titrate their dose.)

    The EU also plans to ban any flavors other than “tobacco” or “menthol” in liquid. Most smokers want a tobacco-flavored liquid when they first begin using an e-cigarette. However, it is very difficult to replicate all of the flavor that comes out in cigarette smoke, and the majority of e-cigarette users eventually experiment with a non-tobacco flavor to see if it is more acceptable to them. According to CASAA’s consumer survey, only 16.7% of consumers “never” use “Fruit, beverage, or candy-flavored liquid.” Many report that switching to a non-tobacco flavor has resulted in them losing their “taste” for the tobacco flavor. There are many reports of people trying “just a puff” of a traditional cigarette after they have begun regularly using a pleasant-flavored liquid, and they say “Yuk” and put it out immediately.

    What Happens Next?

    We don’t expect to see regulations come out of this for quite a while. First, the panel has to review all of the information. Next the panel has to write the report and submit it to congress. I’m really unclear regarding what happens after that. Congress might decide to review the report and hold their own Congressional Public Hearing. Congress might decide to amend the Tobacco Act.

    On the other hand, submitting this report may just be some “pro forma” act that FDA performs and will go on immediately to start issuing regulations. It’s anyone’s guess.

    Resources:

    Federal Register notice of the public meeting: Federal Register, Volume 77 Issue 229 (Wednesday, November 28, 2012)

    Full Text of the Tobacco Act: Full Text of H.R. 1256 (111th): Family Smoking Prevention and Tobacco Control Act - GovTrack.us

    CASAA Consumer Survey Results: https://www.surveymonkey.com/sr.aspx...HfwE9UXRNhE_3d
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    Quote Originally Posted by Vocalek View Post
    What Happens Next?

    We don’t expect to see regulations come out of this for quite a while. First, the panel has to review all of the information. Next the panel has to write the report and submit it to congress. I’m really unclear regarding what happens after that. Congress might decide to review the report and hold their own Congressional Public Hearing. Congress might decide to amend the Tobacco Act.

    On the other hand, submitting this report may just be some “pro forma” act that FDA performs and will go on immediately to start issuing regulations. It’s anyone’s guess.
    What will Congress do ... ??

    [A] Congress might decide to review the report and hold their own Congressional Public Hearing.

    [B] Congress might decide to amend the Tobacco Act.

    [C] Submitting this report may just be some “pro forma” act that FDA performs
    and will go on immediately to start issuing regulations.


    Awe ... Come on folks
    You don't have to be a psychic to predict what Congress will do !!
    So, if we lie to the government, its a Felony.
    But if they lie to us ... it's Politics.

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    cyn·ic
    /ˈsinik/
    Noun

    A person who believes that people are motivated purely by self-interest rather than acting for honorable or unselfish reasons.
    A person who questions whether something will happen or is worthwhile.


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    I'd like to Thank all who supported this worthy cause. Job well done and I tip my hat to each and everyone of you.
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