Tag: Janet Woodcock

Biden Nominates (Pharma) Industry Insider Robert Califf to Head the FDA

Tina Marie (Ms. Cat)

Nature.com

After nearly ten months without a permanent commissioner, US President Joe Biden has nominated Robert Califf, former head of the Food and Drug Administration (FDA), to lead the agency once again. Although some in the research community are opposed to the nomination because of Califf’s ties to industry, others welcome a permanent director after such a long delay, particularly amidst the COVID-19 pandemic, in which the agency plays a crucial part.

Biden Nominates (Pharma) Industry Insider Robert Califf to Head the FDA

They’re lying about Pfizer—The road to Aduhelm: What one ex-FDA adviser called ‘probably the worst drug approval decision in recent US history’ for an Alzheimer’s treatment

Tina Marie (Ms. Cat)

The road to Aduhelm: What one ex-FDA adviser called ‘probably the worst drug approval decision in recent US history’ for an Alzheimer’s treatment

Worse yet, according to the critics, the FDA gave Aduhelm accelerated approval in June, another possibility that had not been raised before the committee. (In notable contrast, the FDA did not act in an accelerated fashion when it finally approved the Pfizer/BionTech vaccine for Covid-19 in August.)**

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Carome believes the shift at the FDA began in earnest in 1992, when the funding stream for the government agency changed. Under an act of Congress that year, the pharmaceutical industry paid “user fees” to support its regulators. The idea was that since the companies would benefit from the FDA’s decisions, they should cover the costs. User fees now pay for roughly 45% of the FDA’s budget.

“The politicians like user fees, because that means they don’t have to allocate taxpayer money,” Carome said, “but what this has done is encourage the agency to become a partner with industry. This has led to regulatory capture of the agency, which is now looking at best interests of the company rather than the best interests of public health.”

**They’re lying about this!? The FDA fast tracked Pfizer’s jab AND accelerated it’s review! The advisory committee didn’t even hold another meeting about the updated data from clinical trials! How is that not different?!

Pfizer, BioNTech’s coronavirus vaccine candidates get FDA’s ‘fast track’ status

FDA, under pressure, plans ‘sprint’ to accelerate review of Pfizer’s Covid-19 vaccine for full approval

FDA Reassigns Staff to Accelerate Full Approval for Pfizer’s COVID-19 Vaccine

Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data

The FDA just fully approved Pfizer’s COVID-19 vaccine in a move that could lead to more vaccinations

Tina Marie (Ms. Cat)1 Comment

The FDA just fully approved Pfizer’s COVID-19 vaccine in a move that could lead to more vaccinations

The shift to full approval could persuade some vaccine-hesitant people in the US to get the shot. A common talking point among skeptics of the COVID-19 shots has been that they’re not fully approved and are technically experimental medicines under emergency OKs. Pfizer’s vaccine winning standard approval directly addresses that concern.

No, it won’t, because they were fast-tracked! All they care about are profits!

He said the fast-track decision appeared more political than scientific since it skipped the usual formal advisory committee meeting and did not fully account for the reports of deaths and disabilities suffered by people after being vaccinated.

Senator Ron Johnson

‘No need to rush’: Senator warns of FDA’s shortcuts to full approval of COVID-19 vaccine

Tina Marie (Ms. Cat)1 Comment

‘No need to rush’: Senator warns of FDA’s shortcuts to full approval of COVID-19 vaccine (Archived)

“I see no need to rush the FDA approval process for any of the three COVID-19 vaccines. Expediting the process appears to only serve the political purpose of imposing and enforcing vaccine mandates,” Mr. Johnson wrote in the letter, a copy of which was obtained by The Washington Times.

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U.S. Surgeon General Vivek Murthy told “Fox News Sunday” that moving the Pfizer vaccine from “emergency” to “full approval” would make mandates more appealing.

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Former FDA Commissioner Scott Gottlieb, who is on the Pfizer board of directors, also said the full approval will prompt more vaccine mandates.

Related:

Gottlieb’s Pfizer Announces $1.95 Billion Deal with Feds for COVID-19 Vaccine

Just hours before the Pfizer vaccine news became public, Gottlieb appeared on CNBC’s Squawk Box to explain that any vaccine will need to be administered on an annual basis.

Source.

Some more notes that I made, about Gottlieb and the coronavirus, in March 2020.