Difference between revisions of "Scott Gottlieb"
(Abolishing inspections of facilities producing biological products) |
|||
| (One intermediate revision by the same user not shown) | |||
| Line 30: | Line 30: | ||
In 2018, Gottlieb, while FDA Commissioner, changed the rules for manufacturing facilities inspections. Until May 2, 2019, FDA inspectors were required to inspect all establishments or facilities producing biological products at least once every two years, and held eight enumerated inspection duties. Since May 2, 2019, FDA inspectors have had none of those duties, and are not required to inspect biological product manufacturing facilities at any time intervals.<ref name=cath/> | In 2018, Gottlieb, while FDA Commissioner, changed the rules for manufacturing facilities inspections. Until May 2, 2019, FDA inspectors were required to inspect all establishments or facilities producing biological products at least once every two years, and held eight enumerated inspection duties. Since May 2, 2019, FDA inspectors have had none of those duties, and are not required to inspect biological product manufacturing facilities at any time intervals.<ref name=cath/> | ||
| − | + | This rule change affects all biologics manufacturing, not just Emergency Use Authorization (EUA) [[countermeasures]]. This includes all [[vaccines]], human and animal, and all other [[biologics]] products. These products include medications for a variety of [[autoimmune conditions]] which patients typically take for life, [[monoclonal antibodies]], and some cancer medications. | |
| − | This rule change explained why the [[FDA]] did not audit [[Pfizer]] and [[Moderna]] prior to large scale commercial deployment of "[[Covid jab | + | As of 2023, there is no legal requirement for an initial [[FDA]] inspection; no minimum interval for subsequent FDA inspections, and there are no legal consequences for compliance failures, such as establishment or product license denial or revocation.<ref name=cath>https://archive.md/uvY7F#selection-757.90-757.173</ref> |
| + | |||
| + | This rule change explained why the [[FDA]] did not audit [[Pfizer]] and [[Moderna]] prior to large scale commercial deployment of "[[Covid jab|Covid vaccines]]". At the time, in late 2020 to 2021 they in addition claimed it was dangerous to send inspectors out due to "[[Covid]]". Later in 2022 some of the inspections were done at suppliers - all found non-compliant with Good Manufacturing Practices. Zero enforcement action resulted from these findings, since it is legal to ship adulterated and misbranded EUA [[countermeasures]].<ref>https://archive.md/wVIuX#selection-801.537-801.686</ref> | ||
=== Punditry === | === Punditry === | ||
Latest revision as of 11:56, 6 December 2024
 Scott Gottlieb     (doctor, bureaucrat) | |
|---|---|
 | |
| Born | June 11, 1972 East Brunswick, New Jersey, U.S. |
| Nationality | US |
| Alma mater | Wesleyan University, Mount Sinai Medical Center |
| Member of | Illumina, National Resilience |
| Party | Republican |
Dr. Scott Gottlieb is an American physician and investor who was the 23rd commissioner of the Food and Drug Administration (FDA) from 2017 until April 2019.
Contents
Career
Gottlieb became[When?] a resident fellow at the conservative think tank theAmerican Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA)[1][2], and a member of the board of directors of drug maker Pfizer,[3]
As of 2024, he sits on the boards of two other companies central in Covid, Illumina, Inc and National Resilience.
Abolishing inspections of facilities producing biological products
In 2018, Gottlieb, while FDA Commissioner, changed the rules for manufacturing facilities inspections. Until May 2, 2019, FDA inspectors were required to inspect all establishments or facilities producing biological products at least once every two years, and held eight enumerated inspection duties. Since May 2, 2019, FDA inspectors have had none of those duties, and are not required to inspect biological product manufacturing facilities at any time intervals.[4]
This rule change affects all biologics manufacturing, not just Emergency Use Authorization (EUA) countermeasures. This includes all vaccines, human and animal, and all other biologics products. These products include medications for a variety of autoimmune conditions which patients typically take for life, monoclonal antibodies, and some cancer medications.
As of 2023, there is no legal requirement for an initial FDA inspection; no minimum interval for subsequent FDA inspections, and there are no legal consequences for compliance failures, such as establishment or product license denial or revocation.[4]
This rule change explained why the FDA did not audit Pfizer and Moderna prior to large scale commercial deployment of "Covid vaccines". At the time, in late 2020 to 2021 they in addition claimed it was dangerous to send inspectors out due to "Covid". Later in 2022 some of the inspections were done at suppliers - all found non-compliant with Good Manufacturing Practices. Zero enforcement action resulted from these findings, since it is legal to ship adulterated and misbranded EUA countermeasures.[5]
Punditry
With his board memberships undeclared, he frequently appears as a neutral expert in corporate media, including on CNBC, and a frequent guest on CBS' Face the Nation.
COVID-19 Censorship
On August 27th 2021, Dr. Gottlieb emailed Todd O’Boyle, a top lobbyist in Twitter’s Washington office, after seeing a tweet disparaging the Covid vaccines.
The tweet was posted by Dr. Brett Giroir, another government health official under the Trump administration, and touted the superiority of natural immunity over vaccine-conferred immunity.
Dr. Gottlieb, who currently has a Twitter following of about 550,000, lobbied for the Tweet to be flagged as misinformation.
Dr. Gottlieb said in the email the language could prove ‘corrosive’ to the nationwide Covid vaccination campaign.
And even though Twitter could not prove outright that the tweet was a violation of its misinformation policy, it was slapped with a ‘Misleading’ label anyway.[6]
National security agencies to stop the next pandemic
Historically, the national security agencies wanted to avoid public health issues. And the public health community didn’t want the clandestine services anywhere near its mission out of concern that everyone with a white coat would be perceived to be a spy. Covid-19 showed us that the intelligence agencies need to be involved in gathering information about emerging infections around the world. This information is held by soft targets.[7]
References
- ↑ https://www.wsj.com/articles/former-fda-commissioner-gottlieb-returns-to-nea-as-venture-investor-11558568895
- ↑ https://www.prnewswire.com/news-releases/nea-welcomes-scott-gottlieb-md-as-special-partner-300855462.html
- ↑ https://www.businessinsider.com/scott-gottlieb-goes-from-fda-commissioner-to-pfizer-board-member-2019-6
- ↑ a b https://archive.md/uvY7F#selection-757.90-757.173
- ↑ https://archive.md/wVIuX#selection-801.537-801.686
- ↑ https://www.dailymail.co.uk/health/article-11616745/Pfizer-board-member-leaned-Twitter-censor-tweet-arguing-natural-immunity-vaccination.html
- ↑ https://anti-empire.com/ex-fda-head-wants-the-cia-involved-in-stopping-the-next-pandemic/
