FDA Reagan Udall foundation investigation - Revision history

Richardpruen at 18:21, 17 November 2022

2022-11-17T18:21:32Z

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	[https://reaganudall.org/operational-evaluation-fdas-tobacco-~~programl page~~ The Reagan-Udall page] on the FDA review page, including links, plus information on progress and links to view the meetings.
			[https://reaganudall.org/operational-evaluation-fdas-tobacco-program The Reagan-Udall page] on the FDA review page, including links, plus information on progress and links to view the meetings.

	[https://twitter.com/VaporAmerican/status/1585759856622899201 AVM Twitter thread]		[https://twitter.com/VaporAmerican/status/1585759856622899201 AVM Twitter thread]

Richardpruen: Changed to make the page appear in search

2022-10-29T09:06:42Z

Changed to make the page appear in search

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	''<br />Let’s wrap by applauding the integrity and courage of these FDA staff members. It takes real guts to speak out like this and here’s hoping they continue to stand tall.''		''<br />Let’s wrap by applauding the integrity and courage of these FDA staff members. It takes real guts to speak out like this and here’s hoping they continue to stand tall.''

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Richardpruen: Added links to top of page

2022-10-28T12:59:40Z

Added links to top of page

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	The information below is derived from an American Vapour Manufacturers twitter thread, with additional information and links to further information added.		The information below is derived from an American Vapour Manufacturers twitter thread, with additional information and links to further information added in this section.



	[[Wikipedia:Reagan-Udall Foundation\|wikipedia's Page on the Reagan-Udall Foundation]]		[[Wikipedia:Reagan-Udall Foundation\|wikipedia's Page on the Reagan-Udall Foundation]]



	[https://reaganudall.org/operational-evaluation-fdas-tobacco-programl page The Reagan-Udall page] on the FDA review page, including links, plus information on progress and links to view the meetings.		[https://reaganudall.org/operational-evaluation-fdas-tobacco-programl page The Reagan-Udall page] on the FDA review page, including links, plus information on progress and links to view the meetings.

			[https://twitter.com/VaporAmerican/status/1585759856622899201 AVM Twitter thread]

	~~{{Break}}~~		== Below is the content from the Twitter thread ==

Richardpruen: Add info and images

2022-10-28T12:52:29Z

Add info and images

Show changes

Richardpruen: added more images

2022-10-28T10:07:54Z

added more images

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	Corrupt political influence infects that entire process. This is truly outrageous and further confirmation of the complaints we have lodged with HHS Inspector General and the Senate Ethics Committee.		Corrupt political influence infects that entire process. This is truly outrageous and further confirmation of the complaints we have lodged with HHS Inspector General and the Senate Ethics Committee.

			[[File:FgHARaFVEAA5Bnt.png\|alt=For the PMTA program, we need to keep the scientific decision-making within OS [Office of Science] as we have more or less done for the SE [substantial equivalence] and EX [exemption from substantial equivalence] programs. Whether perceived or true, it seems that politics (congress, commissioner, or OCD), have been too influential in the scientific decision making of the sciences and the proposed actions.\|center\|frame\|For the PMTA program, we need to keep the scientific decision-making within OS [Office of Science] as we have more or less done for the SE [substantial equivalence] and EX [exemption from substantial equivalence] programs. Whether perceived or true, it seems that politics (congress, commissioner, or OCD), have been too influential in the scientific decision making of the sciences and the proposed actions.]]



	Scientific personnel are being actively and routinely intimidated.		Scientific personnel are being actively and routinely intimidated.

			[[File:FgHASXeVIAElux4.png\|alt=My recommendation would be to have an extra barrier of isolation to prevent such influence with the scientists in the OS. Furthermore, with this influence, staff are feeling intimated by others in more senior leadership positions which creates an unhealthy work environment.\|center\|frame\|My recommendation would be to have an extra barrier of isolation to prevent such influence with the scientists in the OS. Furthermore, with this influence, staff are feeling intimated by others in more senior leadership positions which creates an unhealthy work environment.]]



	Those personnel wish to do the right thing but the agency prevents them.		Those personnel wish to do the right thing but the agency prevents them.

			[[File:FgHATUFVEAAxHBn.png\|alt=<nowiki>The goal of the PMTA program is to authorize tobacco products that move down the continuum of risk from harmful products to less harmful products, yet limit youth initiation. \| feel we have lost our way in the PMTA program. Both industry and CTP have had many challenges with the outcome of the court order where CTP was not prepared for the influx of applications and then changed mid-stream during the year and industry scrambled to submit submissions without a final rule from CTP in terms of what to submit.</nowiki>\|center\|frame\|<nowiki>The goal of the PMTA program is to authorize tobacco products that move down the continuum of risk from harmful products to less harmful products, yet limit youth initiation. \| feel we have lost our way in the PMTA program. Both industry and CTP have had many challenges with the outcome of the court order where CTP was not prepared for the influx of applications and then changed mid-stream during the year and industry scrambled to submit submissions without a final rule from CTP in terms of what to submit.</nowiki>]]


	They know they system is rigged but there’s nothing they can do.		They know they system is rigged but there’s nothing they can do.

			[[File:FgHAUUGUcAABwb1.png\|alt=CTP has explicitly stated that the science supports the notion of a continuum of risk, i.e. that combustible products are the deadliest and noncombustible products appear to be nominally safer. Nevertheless, CTP has elected to conduct a product by product premarket review of new tobacco products. So any innovative product, such as an e-cigarette, would most likely have to undergo a more robust and burdensome pathway to market, e.g. PMTA.\|center\|frame\|CTP has explicitly stated that the science supports the notion of a continuum of risk, i.e. that combustible products are the deadliest and noncombustible products appear to be nominally safer. Nevertheless, CTP has elected to conduct a product by product premarket review of new tobacco products. So any innovative product, such as an e-cigarette, would most likely have to undergo a more robust and burdensome pathway to market, e.g. PMTA.]]



	They also know the agency’s corrupt approach is causing active public health harm but, again, no one will listen to them.		They also know the agency’s corrupt approach is causing active public health harm but, again, no one will listen to them.

			[[File:FgHAVSXUAAIM6eB.png\|alt=The TCA appears to have given an upper hand to the deadliest forms of tobacco products, i.e. combustible products. Unfortunately, it allows them to either be considered pre-existing tobacco products or avail themselves of the easiest premarket pathways, e.g. SE [substantial equivalence], EX [exemption from substantial equivalence].\|center\|frame\|The TCA appears to have given an upper hand to the deadliest forms of tobacco products, i.e. combustible products. Unfortunately, it allows them to either be considered pre-existing tobacco products or avail themselves of the easiest premarket pathways, e.g. SE [substantial equivalence], EX [exemption from substantial equivalence].]]



	They are proposing fixes to the system but FDA leadership doesn’t care.		They are proposing fixes to the system but FDA leadership doesn’t care.

			[[File:FgHAWU9UUAAB0W2.png\|alt=Shouldn't CTP fully embrace a continuum of risk approach and prioritize the issuance of product standards applicable to ALL tobacco products, such as a reduction of a harmful additive, constituent, component, or ingredient that would ensure that the deadliest products allowed on the market by this unfortunate drafting of the TCA would be pulled, and only safer forms of products would be allowed - assuming they are authorized under one of the premarket pathways.\|center\|frame\|Shouldn't CTP fully embrace a continuum of risk approach and prioritize the issuance of product standards applicable to ALL tobacco products, such as a reduction of a harmful additive, constituent, component, or ingredient that would ensure that the deadliest products allowed on the market by this unfortunate drafting of the TCA would be pulled, and only safer forms of products would be allowed - assuming they are authorized under one of the premarket pathways.]]

Richardpruen: Formatting

2022-10-28T09:46:19Z

Formatting

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	As the Reagan-Udall Foundation undertakes its much-needed review of rampant dysfunction at FDA, the agency’s personnel are speaking out – and whey they have to say is shocking. Let’s take a look.		As the Reagan-Udall Foundation undertakes its much-needed review of rampant dysfunction at FDA, the agency’s personnel are speaking out – and whey they have to say is shocking. Let’s take a look.

	~~THREAD 🚨🔎~~

	Using the comment portal that RUF set up, FDA personnel describe a broken culture, corrupt political influence, rigged processes, and retribution for anyone that tries to repair it. Their identities have been shielded.		Using the comment portal that RUF set up, FDA personnel describe a broken culture, corrupt political influence, rigged processes, and retribution for anyone that tries to repair it. Their identities have been shielded.


	There are courageous whistleblowers here from a variety of offices within FDA, all describing a broad pattern of unethical misconduct at the agency. Here are some of the highlights.		There are courageous whistleblowers here from a variety of offices within FDA, all describing a broad pattern of unethical misconduct at the agency. Here are some of the highlights.

	[[File:FgHAMm6VIAAIVC3.png\|alt=There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]\|center\|frame\|There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]]]		[[File:FgHAMm6VIAAIVC3.png\|alt=There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]\|center\|frame\|There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]]]
	Ignoring the science and rigging the outcomes:		Ignoring the science and rigging the outcomes:

Richardpruen at 09:45, 28 October 2022

2022-10-28T09:45:02Z

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	[[File:FgHANhkVUAE3a1h.png\|alt=There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]\|center\|frame\|The so-called leader do not solicit feedback from the actual reviewers, instead, listening to a few of the loudest ducks, who are not the experts in any of the specific disciplines. ]]		[[File:FgHANhkVUAE3a1h.png\|alt=There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]\|center\|frame\|The so-called leader do not solicit feedback from the actual reviewers, instead, listening to a few of the loudest ducks, who are not the experts in any of the specific disciplines. ]]

			{{Megaphoneduck}}

	Dr. Califf postures as a champion of inclusion and diversity. But in reality:		Dr. Califf postures as a champion of inclusion and diversity. But in reality:

Richardpruen: Started building page based on AVM thread on twitter regarding FDA employee comments

2022-10-28T09:43:37Z

Started building page based on AVM thread on twitter regarding FDA employee comments

New page

As the Reagan-Udall Foundation undertakes its much-needed review of rampant dysfunction at FDA, the agency’s personnel are speaking out – and whey they have to say is shocking. Let’s take a look.

THREAD 🚨🔎

Using the comment portal that RUF set up, FDA personnel describe a broken culture, corrupt political influence, rigged processes, and retribution for anyone that tries to repair it. Their identities have been shielded.

There are courageous whistleblowers here from a variety of offices within FDA, all describing a broad pattern of unethical misconduct at the agency. Here are some of the highlights.
[[File:FgHAMm6VIAAIVC3.png|alt=There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]|center|frame|There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]]]
Ignoring the science and rigging the outcomes:

[[File:FgHANhkVUAE3a1h.png|alt=There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]|center|frame|The so-called leader do not solicit feedback from the actual reviewers, instead, listening to a few of the loudest ducks, who are not the experts in any of the specific disciplines. ]]

Dr. Califf postures as a champion of inclusion and diversity. But in reality:

[[File:FgHAOeDUUAAARu6.png|alt=Favoritism, unconscious bias, racism/sexism, permeating the whole office/division, the minority and women constantly being ignored for their suggestions/feedbacks, although they are the ones who did the most amount of work.|center|frame|Favoritism, unconscious bias, racism/sexism, permeating the whole office/division, the minority and women constantly being ignored for their suggestions/feedbacks, although they are the ones who did the most amount of work.]]

And if the scientific review doesn’t comport with the preconceived outcome that FDA leaders want, they just replace the reviewer:

[[File:FgHAPdkVQAA6EHZ.png|alt=And unreasonable workload/deadlines ... micromanaging the selection of the reviewers without allowing rotations, burning out many top performers. In addition. instead of listening to the people who have actually done reviews...the leadership continues to listen to few of the "loudest ducks" who had not conducted many actual reviews, which added bureaucracy and more roadblocks for the reviewers.|center|frame|And unreasonable workload/deadlines ...]]

Naturally, this leads to infighting and jockeying among the people who are supposed to be doing objective analysis:

[[File:FgHAQadVIAENVOi.png|alt=promotes many toxic employees, self-proclaimed "experts", who backstabs/steal credits, which creates even more toxic atmosphere, and more disengaged and disfranchised work force. A thorough cultural change is urgently needed before we lose more real top performers and be left with mediocre and those toxic self-proclaimed "experts".|center|frame|The "so-called" leadership also tolerates/ promotes many toxic employees, self-proclaimed "experts", who backstabs/steal credits, which creates even more toxic atmosphere, and more disengaged and disfranchised work force. A thorough cultural change is urgently needed before we lose more real top performers and be left with mediocre and those toxic self-proclaimed "experts".]]

Corrupt political influence infects that entire process. This is truly outrageous and further confirmation of the complaints we have lodged with HHS Inspector General and the Senate Ethics Committee.

Scientific personnel are being actively and routinely intimidated.

Those personnel wish to do the right thing but the agency prevents them.

They know they system is rigged but there’s nothing they can do.

They also know the agency’s corrupt approach is causing active public health harm but, again, no one will listen to them.

They are proposing fixes to the system but FDA leadership doesn’t care.

Yep.

Those who have tried to speak out internally are swiftly penalized or have their careers derailed.

Leadership at FDA has violated their duty to the American public. This is the appalling culture that Mitch Zeller, Brian King, and Robert Califf have created:

Of course, those personnel are forbidden from dialogue with actual stakeholders. Memo to FDA: you can’t catch Covid over Zoom.

I guess when Senator Durbin or Matt Myers calls the head honcho with their latest demands, ya gotta hop to it.

Infuriating.

What happens when the reviewers concur with an application?

Here’s another and read it closely. Because of political pressure, FDA leadership is *altering* the scientific findings of its own staff and reversing their decisions.

Those personnel also point out that FDA is doing most of this in the absence of formal rulemaking – that is to say, unlawfully. Again, political pressure preventing that.

This deserves to be a major scandal and FDA leadership ought to be truly ashamed. It’s a total disgrace. But the FDA beat writers in the national press have done next to nothing to expose this corruption.

Why is it left to vaping advocates like us to bring this story to light? Why haven’t reporters at NYT, AP, WashPost, CBS, or Reuters tried to cultivate these sources and tell the American public what’s really going on inside that broken agency?

We know why NPR, STAT, TBIJ, and Bloomberg haven’t done it – it’s because they are on the prohibition payroll, taking outright cash payments from billionaires that are engineering the political influence. They condone this corruption and they sold out the public.

These whistleblowers are obviously keen to share their stories and their insight – but apparently no one in the national news media wants to hear it. Those outlets quote unnamed officials at federal agencies all the time. But here? No curiosity, zero effort.

Some people say AVM has been too tough on FDA. But does it still seem “hyperbolic” when we say the agency is rigging the process and is riddled with political influence? Even the agency’s own people can’t engage in a meaningful, constructive dialogue with their own colleagues!

Let’s wrap by applauding the integrity and courage of these FDA staff members. It takes real guts to speak out like this and here’s hoping they continue to stand tall.