FDA December 17 Public Hearing: Key Takeaways
Yesterday, I listened to the entirety of the FDA’s public hearing on the future of tobacco and nicotine alternatives regulation. Electronic cigarette advocates and adversaries spoke on the potential of the FDA to endorse or dismantle the industry. At the end of the day, I can say that the experience was quite encouraging. You can read my notes from the event here.
There were a number of well articulated arguments for less aggressive regulation of electronic cigarettes (when regulation does get implemented that is). We thank those that went and put a real face to the industry in front of the FDA. Here’s three things I took away that I felt worth noting first and foremost.
Everyone wants fast tracking.
A major subject at the hearing was whether new, innovative nicotine replacement therapies and cessation aids should be fast tracked. A rather simple, undeniable argument was presented multiple times. Cigarettes kill roughly 50% of their users. In the U.S. that’s 443,000 deaths a year or about a fifth of total deaths. There aren’t many alternatives to smoking that could possibly be as bad as this. For this reason, a number of speakers felt that fast tracking should be a more accessible option for smoking alternatives and therapies.
Fast tracking would work on two levels. First, products that the FDA would otherwise be tempted to ban until extensive clinical research is done could make their way to the market and be studied through post market surveillance. Statistically, every cigarette smoked is time off a smoker’s life. Bringing even the most experimental products to market (with a few preliminary examinations) is better done sooner than later. Second, fast tracking could allow new, innovative products to label themselves according to intention — that is, electronic cigarettes could be sold with the intention of helping people reduce the amount they smoke, quit smoking, or cut back on the harm done by their smoking. Claims could be updated to match the most recent post market surveillance and ongoing clinical testing.
This change — were it to be made — could mean that electronic cigarette sellers would no longer be forced to tip toe around the topic of smoking cessation or harm reduction. This would make them more competitive with tobacco cigarettes and there are few that believe these claims would be detrimental to public health. If anything, they would reflect a more accurate assessment of the product rather than a legally-responsible, inaccurate assessment.
Dr. Abrams is warming up to electronic cigarettes.
Dr. David Abrams has been a general adversary to electronic cigarettes for some time now. In a recent interview on HuffPost Live, he made statements about the new technology that didn’t win him any friends in the e-cig crowd. Essentially his arguments against e-cigs focused on the non-existence of extensive, reliable, and unbiased research supporting claims made about their success as cessation devices and their low harm.
Granted, in Dr. Abrams’s comments, he didn’t say precisely that he is in favor of electronic cigarettes. But I for one got a sense that he is warming to the idea. In particular, Abrams suggests fast tracking new, innovative technologies. Interestingly enough, the panel actually asked Dr. Abrams for his thoughts on electronic cigarettes. Abrams states that some research has been done, but he doesn’t feel it is sufficient to make any claims about electronic cigarettes. He touches specifically on the idea that e-cigs — no matter how good that are — should not be allowed to bypass quality control standards (I don’t think many e-cig users would argue against this).
As for the research, he says, most of it is done with what he calls a “sample of convenience” which skews results dramatically in favor of electronic cigarettes. Largely, this is correct. New studies are fixing this, but preliminary studies of a new product will almost always be forced to use that product’s early adopters as the sample pool. Still, with a little more information, Abrams says, electronic cigarettes are a definite candidate for fast tracking.
Chantix may actually be what sets back electronic cigarettes.
Chantix came up multiple times during the hearing. It is a drug used to treat smoking addiction that was fast tracked to market due to demonstrated success helping smokers quit. In the time since, a number of very concerning side effects have appeared — chiefly, massive mood swings, night terrors, cardiovascular disease, and suicide. This has cast a very dark shadow on the fast tracking process and may lead the FDA to require even heavier proof before products can be granted market clearance.
Anything that messes with brain chemistry probably shouldn’t be a candidate for fast tracking. One can hardly compare fast tracking a drug that fundamentally alters behavior with that of a device that simulates something already on the market. And yet, the panel seemed to view fast tracking as an all or nothing process. Either it’s available for everything, or nothing. This could mean fast tracking isn’t fast tracked. Fast tracking won’t help current products if the process is reviewed and scrutinized for the next 3 years before anything else can be fast tracked.
So electronic cigarettes branded as cessation devices or nicotine replacement therapy options might take some time to happen due to this blemish on the process. I for one won’t mind a healthy and open fast tracking process as long as all thing fast tracked are clearly labeled as market review products — meaning we don’t know everything that these do, but preliminary evidence is promising.