FDA Referral to Scientific Advisory Committee?
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Oh, oh ... I know.
They're talking about the TPSAC, the Tobacco Products Scientific Advisory Cmte - chaired by this guy:
Chair of FDA Tobacco Advisory Committee Took Tobacco Industry Money to Help Craft Research Agenda for Fraudulent Industry Research Enterprise
And, speaking of chairs ... guess what he recently said about them:
Touching a Chair in a Restaurant Could Be Hazardous to Your Health if Vaping is Allowed, According to Tobacco Control Researcher
They're talking about the TPSAC, the Tobacco Products Scientific Advisory Cmte - chaired by this guy:
Chair of FDA Tobacco Advisory Committee Took Tobacco Industry Money to Help Craft Research Agenda for Fraudulent Industry Research Enterprise
And, speaking of chairs ... guess what he recently said about them:
Touching a Chair in a Restaurant Could Be Hazardous to Your Health if Vaping is Allowed, According to Tobacco Control Researcher
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Here's the roster for the committee
IMO, it adds another plausible layer of delay, like requesting an extension.
And if science is 'bad' it could work for us politically, based on scrutiny and ultimately credibility of science
And if science is 'good' it could work great for us politically, based on idea that Committee might say certain provisions of the proposal are not supported by scientific data to fall under TCA.
I don't get what we'd have to lose by suggesting (or demonstrating good cause for) the referral. Proposal has already admitted it lacks on scientific data to establish some of what it is going for.
IMO, it adds another plausible layer of delay, like requesting an extension.
And if science is 'bad' it could work for us politically, based on scrutiny and ultimately credibility of science
And if science is 'good' it could work great for us politically, based on idea that Committee might say certain provisions of the proposal are not supported by scientific data to fall under TCA.
I don't get what we'd have to lose by suggesting (or demonstrating good cause for) the referral. Proposal has already admitted it lacks on scientific data to establish some of what it is going for.
Whether such a request would be helpful to us or not in terms of either increasing delay, or changing the nature of the science which the FDA will rely upon, might be a question for Azim Chowdhury, Bill Godshall, C.V. Phillips, etc. I certainly have no clue.
I also have no idea who an "interested person" is, either - although the FDA may have already implicitly declared that to be the pubic, by throwing the comments open to everyone. (The FSTPCA doesn't define the term, but it's often used in admin law.)
The one thing that caught my eye is that the sec'y of HHS has to make the determination. This may (by itself) provide some interesting opportunities for political organizing. For example, petitions, perhaps even a public action such as a protest - some event that generates media attention.
If my memory serves me correctly, the new HHS sec'y will be Sylvia Mathews Burwell, who was head of OMB last fall when OMB first kicked the FDA's draft proposed rule back to them. But she was also there when OMB approved the current rule. What differences - if any - exist between them is unclear, since I don't believe the earlier version has ever been made public.
I also have no idea who an "interested person" is, either - although the FDA may have already implicitly declared that to be the pubic, by throwing the comments open to everyone. (The FSTPCA doesn't define the term, but it's often used in admin law.)
The one thing that caught my eye is that the sec'y of HHS has to make the determination. This may (by itself) provide some interesting opportunities for political organizing. For example, petitions, perhaps even a public action such as a protest - some event that generates media attention.
If my memory serves me correctly, the new HHS sec'y will be Sylvia Mathews Burwell, who was head of OMB last fall when OMB first kicked the FDA's draft proposed rule back to them. But she was also there when OMB approved the current rule. What differences - if any - exist between them is unclear, since I don't believe the earlier version has ever been made public.
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When one of these people you noted suggest the idea, and everyone is patting them on the back for that suggestion, you and I will know how it originated. In the meantime...
I'm an "interested person" and see no reason in this moment to not include that request in comments to the FDA.
Where are you seeing this? Are you saying sec'y of HHS makes determination of who is an interested person?
Exactly. I was getting at this in post #3, but glad you were specific about the opportunities.
I'm interested in the overall result (namely: to preserve as much as we can of "vaping as we presently know it"). Who gets what credit is not an issue for me personaly.
I don't know what "interested person" means for purposes of the statutory language you quoted.
The language you quote says that the sec'y "may" decide to invoke the services of the advisory cmte. Normally this type of phrasing in a statute means that the sec'y is making a dermination.
Whenever a public official is so tasked by a law to make such a dermination, their decision becomes a matter of public record, including the basis for doing so. For that reason, it may become the focus of organizing and/or the creation of talking points, press releases, and the like.
So then, can you think of a legitimate reason why this would not be something to pursue in comments? From what I'm reading you say, you cannot but would like to pose question for such tactic to others before you proceed. And maybe, you are implying, before anyone on our side proceeds with this. Is that accurate? Realizing that we are likely to frame our assertions regarding the proposal differently than ANTZ, I am seeing no reason, right now, how this could work against us. Especially since such reporting must be made publicly available.
I would think it would mean any person interested in submitting comments as noted in (2)(B) of FSPTCA (p.23) or as noted in the proposed regulations on p.192 under "A. General Information About Submitting Comments." I would be very curious as to how anyone could interpret "interested persons" to be something other than any person that is interested in submitting comments. And very intrigued if it actually is referring to special subset of the general population (of everyone) and yet not making note of that.
The part I quoted doesn't say "may decide" but does say, "Secretary may make a referral under this paragraph." It is self evident that it has to go through the Secretary, but also fairly evident that the initiation of the referral occurs in one of two ways: 1 - because Sec'y has determined it or 2 - because someone in the general public has requested it. It then seems to prevent any willy nilly request by saying that there must be 'good cause' for the referral.
Which, admittedly, if there is inherent bias on Sec'y's part to not have referrals on certain items go to committee, might lead to situation where 'good cause' was never established. But given the language of the proposed regulations, it seems quite plausible that FDA is expecting such referrals, or at very least, that publicly available comments would be able to show that good cause. If Sec'y then refuses to act on that request, it would open up later lawsuits based on this one point that TCA covered and that Sec'y chose to essentially ignore, even while public record could show that the request was made, and 'good cause' was provided within a comment.
Within context of TCA (and likely within proposed regulations), I would say that "a tobacco product standard" refers to a rule (or rules) that govern tobacco regulations under the authority of the FDA.
On p. 6 of TCA, Sec. 3 with regards to PURPOSE it reads:
Also on p.21 of TCA there is section (907) titled, "TOBACCO PRODUCT STANDARDS"
This makes note of what I feel is pertinent to this thread by stating in (a)(2):
The proposed regulations are seeking revision of tobacco product standards.
This thread is concerned with what is brought up in subsection (5) of section 907, and as quoted in OP.
Looks like there are only two Tobacco Product Standards currently, as outlined in Paragraph (1) of that section...
1) With respect to cigarettes, no flavors except tobacco and menthol
2) Limits on pesticide chemical residue
1) With respect to cigarettes, no flavors except tobacco and menthol
2) Limits on pesticide chemical residue
Let's see, judging by their clickable resumes/bios at the above link for the roster of the FDA's Tobacco Products Scientific Advisory Committee ("qualified experts with minimal conflicts of interest")...
A bunch of anti-smoking "researchers," plus..
Suchitra Krishnan-Sarin, Ph.D. -- ties to Pfizer (maker of Chantix)..
James E. Swauger, Ph.D., DABT -- lifer at Reynolds American (RJ Reynolds)..
[BT alternate: Jeffrey Walker, M.D. -- Altria (Philip Morris)]
And, of course, the Chair, Jonathan M. Samet, M.D., M.S. -- with former ties to BT & bogus studies under his belt..
Chair of FDA Tobacco Advisory Committee Took Tobacco Industry Money to Help Craft Research Agenda for Fraudulent Industry Research Enterprise
http://tobaccoanalysis.blogspot.com/2010/03/chair-of-fda-scientific-advisory.html
"'They've stacked the deck with people who have close ties to the tobacco industry,' said Dr. Alan Blum, a founder of the antismoking group Doctors Ought to Care. 'It's pathetic.'
The panel members are linked to the Center for Indoor Air Research of Linthicum, Md. The center is financed by Philip Morris, the R. J. Reynolds Tobacco Company and Lorillard Inc., three of the nation's largest tobacco companies. Its board of directors is made up of employees of those companies, said Pamela Phillips, an administrator at the center."
6 Members of Panel on Smoking Have Ties to Tobacco Group - NYTimes.com
I'm sure I might have missed some stuff..
Anybody care to dig a little deeper?
Just because I can't think of a reason why it's a bad idea, doesn't mean anything.
I only speculated that making the request and having the HHS sec'y decline to accede might be a useful tool for political action (assuming that it's denied).
I think I'll stop playing "armchair strategist" on this, because I have no experience in such matters, nor any basis for forming any opinion whatsoever.
The speculation was pure idle banter on my part. Nothing more.
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That's from 1990 and I believe it is a different panel.
The current TPSAC committee is stacked with Big Pharma folks...
Alleged Conflict of Interest on FDA Tobacco Panel | Competitive Enterprise Institute
http://www.e-cigarette-forum.com/fo...t-their-drug-industry-conflicts-interest.html
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...setting up FDA for a later lawsuit from vaping industry.
It doesn't matter if it's from 1990..
Bottom line is, Samet was involved back then, and he's now Chair of TPSAC today..
In other words, links to BT & bogus studies are nothing new to him...
As for the 3 mentioned in your links, it appears they're no longer on the current panel...
EDIT: Of course, apparently they were fairly recently.. Hmm...
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Meh.. this is just the easy, publicly available stuff..
I'd wager there's a lot more behind the scenes to this whole e-cig reg proposal saga, which is a lot more damaging & incriminating...
Which is reason to get 'science' involved. If their version of science is 'stack the deck and let the chips fall where they may,' then I say let that be exposed during the comment period so that the saga stands a chance of going another way.
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