So this is huge news, and unfortunately this news happened while I was away on break so I wasn’t able to speak on this issue until now. But here we are, and Vaping’s most mainstream opponent has left the server. But what does this mean? How does this affect the vaping industry? How does this affect the regulations he put in place? Who will replace him? There are so many questions that pop up, and I’ll do my best to give you what I think the answers to these questions are.
Why did he leave?
This is a very important question. It basically gets down to the root of it all, if we learn the true reason for his departure. Unfortunately, only Gottlieb knows, and will only know, the truth. According to Gottlieb himself, he said the only reason he left was because he was tired of being away from his family.
A note from FDA Commissioner @SGottliebFDA to the @US_FDA team… pic.twitter.com/K6iBKhZS5P
— U.S. FDA (@US_FDA) March 5, 2019
It’s perfectly reasonable to leave the FDA due to the pressures of the job itself. I don’t think that it’s that far out to think he did the same. But there’s also much more evidence that point to him being “pushed” out. And I think it doesn’t have much (or maybe a little) to do with vaping.
This article points to one of the best things Gottlieb’s administration has done. Before he left, his generic drug initiative allowed more than 90% of generic drug applications to pass. This means millions of consumers may have a few cheaper options to their prescriptions. While this is great for consumers, this spelled trouble for Big Pharma. Of course it’s not a fix, and insurance companies still hold most of the power in which what drugs the consumers consume. But it was a big step. Then there’s the Opioid Crisis. An epidemic that’s destroying millions of families across our nation day by day, completely manufactured by the FDA and Big Pharma. This didn’t happen under Gottlieb, but it landed on his doorstep when he took office. Only the last couple years have more and more politicians started using the opioid epidemic for political points. And unfortunately for Gottlieb, nothing has been done to remedy the issue. In fact, Gottlieb was heavily criticized after approving “Dsuvia”, or sufenantil, a drug that’s 10x stronger than Fentanyl. Finally, we have the “teen vaping epidemic”. Under his administration, JUUL exploded with popularity with many of its consumers being minors. The ANTZ, almost daily, screamed at Gottlieb to heavily regulate this budding industry either by banning their flavors, or banning them outright. While a comprehensive regulatory pathway was formed, it wouldn’t come to fruition till 2022, and regulations enacted now weren’t really enforced (though he did pen a nasty letter to the biggest vaping companies in the industry, and fined a few companies for child-appealing labels and IP theft).
So, what does any of this have to do with him resigning? Well, it outlines the forces against Gottlieb. And one of the threads that remain throughout each controversy? Big Pharma. Gottlieb once sat upon the board at GlaxoSmithKline and Bristol-Myers Squibb, two of the biggest drug conglomerates out there. Despite his divestments, conflicts of interest still run amok. And if I were a betting man, I’d say Gottlieb was pushed out in favor of someone more…favorable.
What does this mean for Vaping?
So the question remains, what does this mean for the vaping industry, and the regulations surrounding it? Unfortunately, it doesn’t mean much. To start, the Pre-market Tobacco Application, otherwise known as the PMTA, is still on track to being used to limit the industry. This has always been known as the “death knell” of the industry by forcing companies to spend exorbitant amounts of money on trying to get their products approved through a long arduous process. Gottlieb leaving doesn’t mean this program goes away. Sort of. One thing that can happen is that a new FDA commissioner could take his place, and do away with the current pathways, replacing them with a new plan. This, however, is very unlikely. Not too mention, Gottlieb has stated the FDA will continue its plan for regulation as recently as today, when this article was posted.
#FDA is firmly committed to a robust program for putting e-cigarettes through an appropriate series of regulatory gates as an alternative for currently addicted adult smokers; and to taking aggressive steps to reduce their appeal and access to kids https://t.co/8TVV2NPL1B
— Scott Gottlieb, M.D. (@SGottliebFDA) March 11, 2019
But there is hope. Gottlieb leaving DOES mean a new FDA head will replace him. We already know the position Gottlieb has taken against vaping, and while some of it was good, the talks of flavor bans is non-negotiable. So, if the new FDA head were to understand the industry more, understand its origins, understand the economy around it, maybe they will be persuaded into seeing it from more of a humanitarian output. Also, by showing the Trump administration that the vaping community votes and will not vote for quasi-conservatives who claim they’re for deregulation, while regulating an industry, maybe we can put someone in who will help the industry. There is a dark side though. We could have the opposite. Someone who will see the vaping industry as an “easy win”, and will heavily regulate the industry into oblivion, for nothing more than political points, and financial gain. The latter is a lot easier to complete as well.
Overall, Gottlieb leaving is a shock. This industry can never lay and rest, and we’re always on our toes. This is just another wrench thrown into our gears. The plans and pathways we’ve made for ourselves, might be completely uprooted. Because of this inconsistency, we don’t have any security. Without security, we don’t have growth. And without growth, we die. So we need to be the loudest we’ve ever been. This is the time where we need to let everyone know the injustices being done to this industry, and hopefully secure a future where smokers have a technology almost 80% effective against smoking. I don’t want to think about the alternative.
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