FDA Changing the Approach

[KODIAK (TM)]

LOL You are allowed to be cynical anytime ya like CES Kodiak, did you read any of the links provided. They clearly state that the FDA Fees are indeed payed Directly to the FDA not through the treasury anymore per the Prescription Drug User Fee Act.

No, I did not read that. But I can't help but wonder if there is some kind of "bean counter" magic going on here because my understanding is the FDA can't arbitrarily enforce disproportionate fees not approved by congress.

Doing otherwise would put them right in the position you are looking to put them in.

 

[Devonmoonshire]

No, I did not read that. But I can't help but wonder if there is some kind of "bean counter" magic going on here because my understanding is the FDA can't arbitrarily enforce disproportionate fees not approved by congress.

Exactly! Therefore if no one is watching or questioning this practice then what reason do they have to stop doing it?

That is why I raise this question. I am 40 years old and I remember when there were almost No drug adds on television for anything but maybe Beyer Asprin, Tylenol, Robitussin and Nyquil. Now every channel you turn to has some new drug intended to treat something however the side effects of these drugs are horrific, yet they are approved by the FDA even though they pose a significant health risk which the FDA is designed to eliminate.

If they did what they were created to do, regardless of the fees paid they would find these side effects and disapprove the substance and tell the maker of that substance to go back and create something that does not pose ANY risks to the general populous.

 

[Devonmoonshire]

Maybe this answers your question, Devonmoonshire, I dunno. It's pretty dense stuff. I'm not trying to pull your chain, believe me. Just trying to add some insight as someone who worked for the federal government for almost 33 years (and as an attorney as well).

http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18624.pdf

P.S. I don't claim this makes me an expert on the FDA, the mysterious processes of the federal government or anything else for that matter, other than my arcane specialty of federal personnel law.

I submitted this document to CASAA for review by their legal analysts for the possibility of rebuttal of their practices as the numbers listed in the document show VERY CLEAR EVIDENCE of a conflict of interest in favor of all applicants based on the percentages of the fees vs what comes from the national treasury. The funds used for testing show that Greater than 50% of said funds comes from the applicant in the form of fees which Proves beyond a shadow of a doubt that there exists the possibility of a bias in favor of the applicant based on financial gains.

Thank you very much for this document as it may end up being a Key piece of proof showing evidence of the Possibility of favoritism by the FDA.

Sincerely;
Nate

 

[sqirl1]

I think the executive and legislative branches of government are a lost cause at this point, but there's one branch left that I still have faith in: the judical branch. The best solution is to conserve our resources (while still being vocal of course) and wait until the time is right, at which point we aggressively sue them and make the tobacco and pharmaceutical industries watch as the courts tear up their precious deeming regulation page by page. We'll sue them and we will win.

 

[Devonmoonshire]

I think the executive and legislative branches of government are a lost cause at this point, but there's one branch left that I still have faith in: the judical branch. The best solution is to conserve our resources (while still being vocal of course) and wait until the time is right, at which point we aggressively sue them and make the tobacco and pharmaceutical industries watch as the courts tear up their precious deeming regulation page by page. We'll sue them and we will win.

I agree 100% sqirl1. After enough time has passed there will be sufficient evidence to PROVE that the actions they are taking DIRECTLY lead to the deaths of thousands if not hundreds of thousands of people due to regulating a viable healthier and effective alternative to smoking cigarettes out of existence. This in essence would mean that they committed mass manslaughter on a nationwide scale all in the name of profit margins and to appease the uneducated people who would have them take over the raising of their children rather than taking responsibility for the education of their children themselves.

 

[badwolf91]

The children are always the excuse and I 100% agree, just had to say it as every fear mongering news add has been to save the children when the only thing going to save these kids is the people raising them properly... much of them who haven't themselves been taught correctly and need to stop and think. Adults like flavored things this has nothing to do with kids using it as I have said before alcohol flavorings have not brought kids in the flocks, its just a faulty way of placing blame since the kid likes their flavored candy.. you know what I like candy too and im a big boy. Theres just no evidence behind any of that its just something they can say that will get some idiot with no initiative to learn about whats going on a reason to say ohhh that's bad. Yet they will continue to stuff themselves with these drugs that are mentioned above and eat at mcdonalds every day.

 

[Devonmoonshire]

The children are always the excuse and I 100% agree, just had to say it as every fear mongering news add has been to save the children when the only thing going to save these kids is the people raising them properly... much of them who haven't themselves been taught correctly and need to stop and think. Adults like flavored things this has nothing to do with kids using it as I have said before alcohol flavorings have not brought kids in the flocks, its just a faulty way of placing blame since the kid likes their flavored candy.. you know what I like candy too and im a big boy. Theres just no evidence behind any of that its just something they can say that will get some idiot with no initiative to learn about whats going on a reason to say ohhh that's bad. Yet they will continue to stuff themselves with these drugs that are mentioned above and eat at mcdonalds every day.

I agree Badwolf91. It is very unfortunate that our own government has in essence "Bred" entire generations of people who feel they need not take responsibility for their own actions. It is always "Somebody Else's Fault".... "You Should Ban Guns Because if I put one to my head and pull the trigger it will kill me" how about this for a response..... "DON'T FRIGGIN DO IT THEN YOU IDIOT!!!!"

Society in this world as a whole has gone completely down the toilet flushed right alongside the turd next to it. People need to take ownership of their own responsibilities including RAISE YOUR OWN KIDS FOR GOD'S SAKE!! Stop taking things away from other people because YOU are too irresponsible to raise your children. Or better yet... if you are too irresponsible to RAISE YOUR CHILDREN.......

STOP HAVING THEM!!!!!!!!!!!

Oiy I get so irritated with people who think it is someone else's responsibility to raise the kids THEY brought into this world.

 

[badwolf91]

I like you you sound like me ranting. again agree 100%, and off topic but around guns I saw a news flash where a lady was complaining about our right to carry because her son was shot in a robbery.. (obviously the robbers got their guns black market and did not have permits..........) what if I was there and put a hollow point into that guy because he had no idea I was carrying and saved his life.. im sure she would have a different approach. Lets just let the bad guys carry illegally? Responsibility is key and not to just echo what you said but lets stop playing the blame game and be a responsible, honorable America again (I know there has always been corruption in business from the early 1800s and far before that even but we need to learn from our past not ignore it and dumb ourselves down buying into everything the media says... form your own opinions and fight for whats right dont just take someones word for it!! look at whats happening to your fellow people). Too many people are just having kids and don't want to take that responsibility at all its just a game to them and I see so many where somebody else has to raise their kids for them and its really sad. A developing mind needs guidance more than anything, these extreme regulations and obvious corruptions are what are causing people without any guidance to lash out. sorry were getting off topic here, I really like your idea, there should be 100% transparency in gov't. They are supposed to be for the people, not the people for them, pretending they are trying to help us. we actually work hard for our money and it seems many officials don't understand what a dollar is or how hard some of us work to make it before they take half of your check and then already tax everything you buy on the dollar. gov't shouldn't play a role in your everyday decisions, it shouldn't have to you should be able to make them for your damn self, the ecig industry was doing great except for a few mislead ...... who let kids get into their juice..just leaving it out on the floor or what? lock that stuff away like a medicine or any other hazardous chemical like cleaners. (I wonder how many OD's on the FDA approved medications happen a year actually resulting in death making ejuice problems seem minimal, and not even on accident sometimes.. oxy cotin, a kid around here died because he took any 80 mg thinking oh its just a small pill and only one.... that little pill is the FDA approved pure {OTHER STUFF}, believe me sadly iv been there and got as far away from that life as I could, trying to be the best person I can now) Or a spill of liquid for example, lets not wash it off or take proper precautions if indeed it happens as it can, nobodies perfect. Now they want to destroy most of what (mainly) good people have worked hard for. As if this passes as is I don't see a lot of our equipment being out there eventually and if its classified as tobacco then were in that same group of sin tax's and a whole new world of bullcrap right away. This is in no way tobacco they need to make another try that's more realistic. The industry seemed to be regulating itself pretty well.. ecigs are their own separate entity not tobacco.
I have a 100% chemical splash body suit for my DIY mixing and haven't even started just taking every caution I can every where I can, respirator, face mask for my 100mg nic. I was told maybe get 50mg but I understand chemistry and I vape 24 mg so why get double what I vape and water it down. I came into this wanting to measure out perfectly and be able to make good amounts without using half my base. for someone not taking as much caution as I am maybe but this is literally going to look like a chemistry lab as it should as that's what it is. checking every small detail with scrutiny multiple times and I have researched until my eyes bled.

sorry you got me going and I cant stop adding in little bits, sorry if this is too much :/.. I support everything you have said, transparency in a group that is supposed to be there to serve the people, not hide behind black curtains, many of them at that. and tell us who we can be. If I can do anything to help let me know and I will be right with you messaging politicians if needed or whatever it takes as im sure theres no way we could actually speak with these people being just normal citizens. I am trying to get much more involved politically but its not easy without a million dollars.

Edit: gad sorry this message is massive, ill try to keep it minimal going forward!

 

[Devonmoonshire]

I like you you sound like me ranting. again agree 100%, and off topic but around guns I saw a news flash where a lady was complaining about our right to carry because her son was shot in a robbery.. (obviously the robbers got their guns black market and did not have permits..........) what if I was there and put a hollow point into that guy because he had no idea I was carrying and saved his life.. im sure she would have a different approach. Lets just let the bad guys carry illegally? Responsibility is key and not to just echo what you said but lets stop playing the blame game and be a responsible, honorable America again (I know there has always been corruption in business from the early 1800s and far before that even but we need to learn from our past not ignore it and dumb ourselves down buying into everything the media says... form your own opinions and fight for whats right dont just take someones word for it!! look at whats happening to your fellow people). Too many people are just having kids and don't want to take that responsibility at all its just a game to them and I see so many where somebody else has to raise their kids for them and its really sad. A developing mind needs guidance more than anything, these extreme regulations and obvious corruptions are what are causing people without any guidance to lash out. sorry were getting off topic here, I really like your idea, there should be 100% transparency in gov't. They are supposed to be for the people, not the people for them, pretending they are trying to help us. we actually work hard for our money and it seems many officials don't understand what a dollar is or how hard some of us work to make it before they take half of your check and then already tax everything you buy on the dollar. gov't shouldn't play a role in your everyday decisions, it shouldn't have to you should be able to make them for your damn self, the ecig industry was doing great except for a few mislead ...... who let kids get into their juice..just leaving it out on the floor or what? lock that stuff away like a medicine or any other hazardous chemical like cleaners. (I wonder how many OD's on the FDA approved medications happen a year actually resulting in death making ejuice problems seem minimal, and not even on accident sometimes.. oxy cotin, a kid around here died because he took any 80 mg thinking oh its just a small pill and only one.... that little pill is the FDA approved pure {OTHER STUFF}, believe me sadly iv been there and got as far away from that life as I could, trying to be the best person I can now) Or a spill of liquid for example, lets not wash it off or take proper precautions if indeed it happens as it can, nobodies perfect. Now they want to destroy most of what (mainly) good people have worked hard for. As if this passes as is I don't see a lot of our equipment being out there eventually and if its classified as tobacco then were in that same group of sin tax's and a whole new world of bullcrap right away. This is in no way tobacco they need to make another try that's more realistic. The industry seemed to be regulating itself pretty well.. ecigs are their own separate entity not tobacco.
I have a 100% chemical splash body suit for my DIY mixing and haven't even started just taking every caution I can every where I can, respirator, face mask for my 100mg nic. I was told maybe get 50mg but I understand chemistry and I vape 24 mg so why get double what I vape and water it down. I came into this wanting to measure out perfectly and be able to make good amounts without using half my base. for someone not taking as much caution as I am maybe but this is literally going to look like a chemistry lab as it should as that's what it is. checking every small detail with scrutiny multiple times and I have researched until my eyes bled.

sorry you got me going and I cant stop adding in little bits, sorry if this is too much :/.. I support everything you have said, transparency in a group that is supposed to be there to serve the people, not hide behind black curtains, many of them at that. and tell us who we can be. If I can do anything to help let me know and I will be right with you messaging politicians if needed or whatever it takes as im sure theres no way we could actually speak with these people being just normal citizens. I am trying to get much more involved politically but its not easy without a million dollars.

Edit: gad sorry this message is massive, ill try to keep it minimal going forward!

No Apologies necessary at all my Friend, it is a well thought out and very pointed and precise collection of statements of pure 100% Facts.

Another angle that not many folks are looking at is that THIS has taken the place in the media of all the questioning that was beginning to get going about the FDA's approval of so many drugs that have lethal side effects.

Personally I think they are using this as a tool to refocus the American People Away From Their Mistakes by allowing lethal pharmaceuticals into the prescription drug list.

Lets think on that for a few moments and realize that this is just a ploy to draw attention away from themselves and their clearly lethal errors in approval.

 

[Dasbeermeister]

I'm not trying to make excuses for the FDA but with the way the do their double blind studys on new drugs if the group using the drug has only one more occurrence of a side affect over the placebo group then they have make the warning.
So if 1 in 5000 of a placebo group poops their pants and 2 in 5000 of the actual drug group poops their pants there will be an uncontrollable BM warning on said drug.

 

[Devonmoonshire]

I'm not trying to make excuses for the FDA but with the way the do their double blind studys on new drugs if the group using the drug has only one more occurrence of a side affect over the placebo group then they have make the warning.
So if 1 in 5000 of a placebo group poops their pants and 2 in 5000 of the actual drug group poops their pants there will be an uncontrollable BM warning on said drug.

Well, technically there is NO excuse that can justify the FDA putting out Humera. A Drug that is known to cause certain types of cancer. There is Nothing Anywhere that can convince me that ANY type of cancer causing drug has ANY place on the FDA's approved list.

They screwed up and now they are trying to put up a smoke screen to make it go away. Well I got news for them, it is NOT going to go away. EVER, not as long as their is breath in my lungs and life in my body.

 

[Devonmoonshire]

Well the latest From CASAA seems to indicate we are close to the CTA.

CASAA is shooting for releasing the Call to Action within a week.

In addition to working on the Call to Action, CASAA is also working on other related and important activities:

1) We are filing for an extention to the comment period, increasing it to 180 days.
2) We are putting together a new e-cigarette user survey to provide statistical data for the official CASAA public comment, which requires a review of all of the requests for information made by the FDA in the proposed rules.
3) We are compiling a list of potential "asks" to petition Congress regarding the FDA's actions.
4) We are still working out facts of the rules vs. rumors/opinions (ex. definition of "finished product," actual costs of filing applications, number of comments allowed, etc)
5) We are still collecting information for the Call to Action, which will include instructions for submitting comments so they show up publicly, a summary of the rules and our objections and talking points for members to pick and chose from when submitting their story. (Note: the CTA will be written for individual comments, so it won't be asking members to submit comments with all of the technical and science facts like the CASAA comment will have.)

We know people are chomping at the bit, however, we cannot take the risk of "shoot first, ask questions later." CASAA has been gearing up for this for 5 years now and we aren't going to risk dropping the ball now. We continue to ask members to be patient and let us do this the right way. We are not leaving this to the last moment, so there is no need to worry that you will be under the gun time-wise after we release the Call to Action. Once we release the CTA, members will still have over 60 days to submit their own comments.