elaine - congrats on becoming the ecig community's very first rock star!
great job.
i was wondering - when you have a moment, would you be able to post some of the harder questions the judges posed to NJOY? I would be interested in seeing what the angle was.
The NJOY lawyer did not have the floor for more than 5 or 10 minutes of the one hour hearing. He started to talk about the FDA wanting to regulate all tobacco products under FDCA as it did in the case of Brown & Williamson
The exchange between a couple of the judges and Garre (the NJOY attorney) about what products might be regulated under the Tobacco Actlasted for several minutes and I did not catch everything that was said. One of the judges seemed concerned about street drugs, and then wondered whether injectable nicotine would be covered under the Tobacco Act. NJOY's attorney stated that the court needed to limit its consideration to tobacco products, not street drugs.
When Judge Garland asked why the FDA wanted to regulate the products under FDCA, if the intent was to ban them, FDA's attorney took over the podium again. She claimed that the FDA wants to reduce the harm caused by smoking (I snorted at that), and said something about destroying the incentive to do clinical studies. I was not following her logic there. She did state that the FDA would want to ban them if they are not safe. That's when she went into her speil about working in cooperation with manufacturers and made the statement that they want to fast-track new "nicotine maintenance" products.
On thinking about this a little more, I am wondering whether, when she said "nicotine maintenance," she meant taking the existing NRTs, continuing to regulate them under FDCA, and extending the approved amount of time for use. It may be the FDA's theory that we won't need electronic cigarettes as an alternative if they offer us longer use of patches, gum, lozenges.
I recently posted on the Documents page of the CASAA site a copy of a "Citizens Petition" (which should more accurately be called a "Lobbyists Petition") to the FDA from the CTFK, ALA, AHA, and ACS (does that group sound familiar?) regarding smoking cessation products.
http://www.casaa.org/files/TFK_Citizen_Petition_-_FDA-2010-P-0454.pdf
Because the health risks of continued tobacco use are so serious, this new approach should provide an opportunity and an incentive for the development and approval of more effective smoking cessation products and beneficial revisions to current labeling requirements.
The Petitioners urge that products approved by FDA as tobacco cessation aids pursuant to its drug authority should meet the same high standards for safety as other products approved as drugs. FDA's goal should be to apply those standards in a way designed to maximize the number of lives saved based on the best available evidence and to encourage product development and marketing with those goals in mind.
Call me cynical, but this sounds to me like a back-handed way of saying "Don't allow products like e-cigarettes on the market to compete with our benefactors' products. Keep the hurdles high!"
Under Action Requested:
Issue a guidance that states that when reviewing applications to market new smoking cessation products and when considering changes to labels on existing products, the agency will evaluate the risks of smoking cessation products against the risks of continued tobacco use.
Again, call me cynical, but wasn't FDA already using that as their justification for keeping Chantix on the market, despite all the adverse events and deaths? How about changing the wording to "...against the risks of continued smoking" and applying that guidance to keeping e-cigarettes on the market?
Again, under Action Requested
In accordance with the Family Smoking Prevention and Tobacco Control Act, make the development of smoking cessation products a priority and transfer the evaluation of applications for these products from the Division of Anesthetics, Critical Care and Addiction Drug Products to the Office of Oncology Drug Products. Such a transfer would allow smoking cessation products to be evaluated by medical reviewers with expertise in cancer, which is a leading cause of death resulting from tobacco use, 1 and by regulators with experience in designing programs to encourage the development of drugs where a great need exists.
This sounds OK, even logical on first read. But, for the third time call me cynical, and I can't help but wonder whether the "axis of evil" has some ulterior motive. The text of the Tobacco Act has this to say:
‘(c) Tobacco Dependence Products- A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is subject to the requirements of chapter V.
So it is clear that the Tobacco Act is NOT governing how smoking cessation products are regulated, and defers that authority to the existing law, FDCA. Is the "axis of evil" petition an attempted end run around congress to try to get "modified risk" tobacco products regulated under FDCA?
