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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.]] | |||
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