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
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)
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)
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)
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)
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.
About the FDA's December 17 hearing
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
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.
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.
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