Deeming Regulations have been released!!!!
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Except you're leaving out the expense of FDA approval as a drug from your estimates as well as FDA compliance throughout each year of operation. Even when a drug goes generic,, the cost of an ANDA (way shorter form of the original new drug application) is considerable and the costs of ongoing compliance are as much as the original drug company had to spend. The projected expense for a PMTA filed for a vape product is already viewed as too high for smaller manufacturers and it's orders of magnitude smaller than for drugs.
Not to say that the US pricing aren't excessive for just about every drug out there, but you have to consider all the costs, not just the inexpensive bottle of nic you use at home.
I'm just curious about it because most of the Media Headlines paint Gottlieb in a Positive light. And seem to have a somewhat common theme.
And that is that he was "Tough on e-Cigarettes".
According to this article, he resigned to be able to spend more time with his family. He had been travelling from DC to his home in Conneticut every weekend. I imagine that was pretty rough on family life.
FDA Commissioner Gottlieb, who raised alarms about teen vaping, resigns
The guy is a millionaire and could have afforded a home in each location, but likely the wife and kids didn't want to move to DC. I kind of respect someone who values family over everything else.
Yeah... I have heard that Reason used Many Times before.
LOL
But the Reason Isn't what I am Wondering about. It is the Timeframe that the Decision was reached that is Interesting.
Because Policy and or Statements after such decision can/may have a Different Spin than those when you plan on riding things out until at least 2020.
Fact is a commute from Westport CT to Washington is a real nightmare. If he's flying it's a long drive to the airport for the area with regular NY to DC flights, and if he uses Acela train service it's a two commuter train ride for him. Given his children are relatively young I expect the family had no desire to pull them out of the Westport school system for an unknown period of time for the relocation.
I have an ex who got handed a six month placement in Washington and was given the option of being put up Monday to Friday there in a hotel, or commute each day from NY. We lived in an area of Manhattan with easy access to the airport without traffic. They made it as bareable as possible for her, but even with a car picking her up at 6:45 every morning for a 7:30 shuttle flight that takes an hour, landing at 8:30 and be at work by 9 AM then the reverse in the evening was really wearing on her. Even though she was home by 7-7:30 PM she was shot for say going out to dinner on a weeknight. I can easily see how being separated from your family all week, add in the commute time, the discomfort of rushing back and forth during the week to attend your kids events, parties, birthdays, all that stuff, would take a lot out of anyone.
It's not like he needed the job, and with the specific pressures he faced, combined with working for an administration under seige and the family dislocation and disruption, I'm impressed he made it this long.
Whoever his permanent replacement is will likely be under a "don't make policy" set of instructions to keep the tea party libertarian side of the republican senate happy as at this point any pretense of seeking bipartisan support is out the window. That's not me being optimistic, as it could turn out badly. What saddens me is they he was one of the most competant appointments this administration made who was respected by both sides of the aisle, and I hate to see a capable person pack it in because it's just not worth the hassle.
I have an ex who got handed a six month placement in Washington and was given the option of being put up Monday to Friday there in a hotel, or commute each day from NY. We lived in an area of Manhattan with easy access to the airport without traffic. They made it as bareable as possible for her, but even with a car picking her up at 6:45 every morning for a 7:30 shuttle flight that takes an hour, landing at 8:30 and be at work by 9 AM then the reverse in the evening was really wearing on her. Even though she was home by 7-7:30 PM she was shot for say going out to dinner on a weeknight. I can easily see how being separated from your family all week, add in the commute time, the discomfort of rushing back and forth during the week to attend your kids events, parties, birthdays, all that stuff, would take a lot out of anyone.
It's not like he needed the job, and with the specific pressures he faced, combined with working for an administration under seige and the family dislocation and disruption, I'm impressed he made it this long.
Whoever his permanent replacement is will likely be under a "don't make policy" set of instructions to keep the tea party libertarian side of the republican senate happy as at this point any pretense of seeking bipartisan support is out the window. That's not me being optimistic, as it could turn out badly. What saddens me is they he was one of the most competant appointments this administration made who was respected by both sides of the aisle, and I hate to see a capable person pack it in because it's just not worth the hassle.
I wonder if this is in relation to salts? They didnt say "who" they sent this letter to, but I wonder what the motivation is in asking for someones research on the topic of pH.
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM433603.pdf
"Under section 904(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is requesting that manufacturers of tobacco products submit documents relating to research on the effects of pH of smokeless tobacco products. This request applies to research relating to the effects of pH on all such tobacco products and their components, parts, or accessories, including those products for research, investigational use, developmental studies, test marketing, and/or commercial marketing. "
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM433603.pdf
"Under section 904(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is requesting that manufacturers of tobacco products submit documents relating to research on the effects of pH of smokeless tobacco products. This request applies to research relating to the effects of pH on all such tobacco products and their components, parts, or accessories, including those products for research, investigational use, developmental studies, test marketing, and/or commercial marketing. "
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Don't let it happen again!
In the future, I will include every piece of minutia that I can possibly conjure up in every post.
I agree 100%. Very few in either party have any willingness to compromise at all. Ever piece of legislation that I see voted on as split pretty much straight down party lines. There are maybe 4 or 5 people from each party that are willing to vote against their party when it's right. IMHO, it's those hand full of people in each party willing to vote across lines are the ONLY ones that deserve to be reelected, but something tells me their parties will make sure they aren't.
I'm trying to remember exactly when Juul hit the market. IIRC, it was sometime during the first half of 2015. I got one that summer to play with, after reading their patent for salts. In any case, I don't recall any "salt" products at all prior to Juul.
wiki...
The Juul electronic cigarette was introduced by PAX Labs on June 1, 2015.
Salts, in relation to ecigs, go back to at least 2009.
Yeah, Vermont Vapors was playing with pH from the beginning of their venture (2009).
Although they didnt market the term "nicotine salts", it is essentially what they were creating.
Although they didnt market the term "nicotine salts", it is essentially what they were creating.
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Nah, it wasn't directed at you, but I can see how it might look that way, and for that I apologize. It was more about how we lose sight of the total costs of a product on the market. Let's face it, even commercial juice which has potentially a huge markup has already seen an increase in operating costs just for stuff like registration with the FDA and an uncertain future. Vape shops that lost the profit on house juice has to make it up somewhere or go out of business (which quite a few did) so retail store prices did push higher.
The fact is the FDA drives prices up on all the items it actively regulates. Things that slip through like supplements they can't drive up costs on because they're hands were tied by legislation (thanks to Hatch and the large vitamin businesses in his state of Utah). A good portion of that is driven by their utter terror of making a mistake, which despite all efforts still happen. Look at the glaring errors they made with opiate approvals (no, it wasn't a subtle unintended consequence, it was predictable but they felt backed into it, same with other drugs released and then removed from the market). Every time they get burned by the wrong call they get more conservative and demand more information and testing, the costs of which are of course passed on to the consumer. That mindset is just as loaded against vaping as everything else. Gottleib was the only one willing to step forward (only one on his level) and say absolute safety wasn't a proper standard with vaping, harm reduction, not elimination, is.
The only time the FDA kinda functions that way is in compassionate use passes handed out on drugs in the pipeline but not ready for prime time that show promise in treating fatal illnesses. Even then they're reluctant, and getting a compassionate use approval can be extremely difficult to obtain. Never mind expecting something like vaping. But Gottleib saw that even though all the evidence wasn't in, vaping could be a game changer in reducing tobacco related deaths. Maybe it's not perfect, and might not be something a nonsmoker should use for decades, but it still has a role. I respect him for taking the chance he did in proposing that stand. But everyone dumped on him for bring either too soft or too hard on the industry.
If that's the focus it's hard to see what road that would take vaping down. I can sort of see the issue relating to whether high nic concentrations like in a pod are more of a problem for nonsmokers who end up exposed to more nic than they need to (which if you're not a smoker should be zero). But no one has yet shown that Juul results in addiction. There are a handful of anecdotal reports of kids who say they can't stop using them, but that does not establish causation. And it doesn't allow for total intake. The tiny puff on a Juul pod isn't delivering all that much in a puff. I wonder just what the average volume vaporized per draw really is to determine that and compare it to say what we consider "standard" vape gear especially with subohm use.
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