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Comments by Larry D. Sasich, Pharm.D., M.P.H, FASHP Public Citizen’s Health Research Group Before the FDA’s Public Meeting on the Prescription Drug User Fee Act (PDUFA)
citizen.org ^ | SEPTEMBER 15, 2000 | Vanity, excerpt from Sidney Wolf, MD

Posted on 05/10/2021 7:26:09 PM PDT by ransomnote

I went looking for the reason the FDA no longer is invested in protecting the public. The FDA has silently observed illegal advertising of unapproved drugs and treatments like the Covid 'vaccines'. It remained silent throughout the CDC and Fauci's push to falsely portray the 'vaccines' as FDA approved. The FDA even helped the CDC participate in a feeble review of Covid vaccine safety, a role for which the FDA is unprepared.

The FDA helped the CDC 'scrub' clean a review of the worrisome number of deaths following Covid vaccination by abandoning the traditional role of the FDA and exceeding its legitimate professional, medical capacity. 

"FDA when it evaluates drug products or other biologic products  - there are two assessments of causality. One is by the local doctor and the other is by the sponsor or drug manufacturer. The FDA does not opine on causality (FDA doesn't opine on whether a death was due to a product).

A typical new drug, after 5 deaths, would get a black box warning. Your listeners would see that on TV, "May cause death...."

At about 50 deaths for a new product, it's pulled off the market.

We do have some precedent for vaccines. In the 1976 swine flu pandemic, we attempted to vaccinate 55 million Americans. There were 500 cases of Guianne Barre syndrome (ascending paralysis)  and 25 deaths. The program was killed at 25 deaths.

We know annually the influenze vaccines (multiple manufacturers), 195 million people vaccinated about 20 to 30 deaths are reported through VAERS.

In the US today, we have approximately 77 million individuals fully vaccinated for Covid and we have 2602 deaths. 

[ransomnote: at the time of this writing, COVID DATA - OpenVaers states a total of 3544 deaths]

So it's unprecedented how many deaths have accrued. Previous studies indicate only 1% to 10% of adverse events following vaccination are ever reported to VAERS.

[ransomnote: Certainly less than 20% of received reports have been published by the CDC for the Covid 'vaccines', so actual reported deaths and other adverse events are underreported.]

Most of the deaths occur on days 1, 2 and 3 (some in the vaccination clinics) and are often reported by nursing staff etc.  On March 8, the CDC announced with little fanfare it had reviewed about 1600 deaths with unnamed FDA doctors and they indicated not a single death was related to the vaccine.

That was concerning in the academic community. I have chaired and participated in dozens of safety monitoring boards and critical endpoint committees, and I can tell you based on my experience that kind of work would have taken many months to review all the laboratories, the death certificates, and all the circumstances.

It is impossible for unnamed regulatory doctors without any experience with Covid-19 to opine that none of the deaths were related to the vaccines, so I think this was effectively a scrubbing, like we've seen elsewhere." ~ Dr. Peter McCullough

COVID Vaccine Killing Huge Numbers, Warns Leading Doctor – Liberty Sentinel [32 minute video] (freerepublic.com)

The 'talking points' distrubuted by the CDC, MSM etc. say that no deaths have been attributed to the Covid vaccines, but in reality, deaths resulting from vaccination are being scrubbed and suppressed, in the US, just as they are in Israel. Fortunately for Israel, Israeli citizens and physicians forged their own route around the information gatekeepers and exposed the harm caused by the 'vaccines' that their government agencies are suppressing.

Israeli People Committee’s Report Find Catastrophic Side Effects Of Pfizer Vaccine To Every System In Human Body

In the United States, the FDA is now signalling it will grant the experimental Covid vaccines full FDA approval. This is being pushed to help the CDC and Fauci force them on the public, paving the way for these needless, dangerous bioagents to become mandatory.

Currently, it's not legal to mandate experimental drugs or treatments. Medications withheld from the public, like HCQ and Ivermectin were blocked to meet the conditions required for the Covid-19 vaccines to receive Emergency Use Authorization in the first place. But as lawsuits are pushing the implementation of Ivermectin in specific medical cases, the 'vaccine's EUA status is in jeapordy.

So, the FDA/CDC/Fauci triumverate is floating the idea of skipping the years of study normally required to test products prior to FDA approval, and just whitewashing these experimental Covid-19 vaccines as 'FDA approved", rendering the term meaningless.

How could the FDA do this to the American people?

I wondered if it was compromised the same way CDC is compromised. In 1992, the CDC was essentially weaponized in 1992 when CDC Foundation was authorized by congress and began accepting donations. Bill Gates (largest donor), George Soros, and other 'interests' began formally driving the the decision making. 

Bill Gates, George Soros and others are driving the CDC's medical Tyranny with Private Donations to CDC Foundation. We have to reject the CDC to free ourselves.

The FDA doesn't appear to have the same donor control as the CDC, but it is compromised and now a partner with Pharma. In 1992  Congress passed the Prescription Drug User Fee Act (PDUFA). When reauthorized in 1997, it opened the door to the  Food and Drug Administration Modernization Act (FDAMA). This toxic duo of the PDUFA - FDAMA made the FDA a partner of Pharma and depleted funds for safety surveillance and  monitoring of prescription drug advertising, and manufacturer and import inspections.

Here's the FDA's current page for 2021's Prescription Drug User Fee Amendments | FDA

Since candid articles about this act remaining on the Internet are hard to find, I'll include  a link to an old article (2002) by PBS here describing the PDUFA: The Fda - How Independent Is The Fda? | Dangerous Prescription | FRONTLINE | PBS

Below is excerpt of another article from 2000 identifying what I believe is the reason behind the rotting of the FDA. 

Comments by Larry D. Sasich, Pharm.D., M.P.H, FASHP 
Public Citizen’s Health Research Group
Before the FDA’s Public Meeting on the Prescription Drug User Fee Act (PDUFA)

Testimony on Prescription Drug User Fee Act (PDUFA) - Public Citizen

"Public Citizen appreciates this opportunity to comment on the Prescription Drug User Fee Act (PDUFA) and what we hope will be its non re-authorization in September 2002.

When first put forth in 1992, PDUFA appeared to be a reasonable attempt to improve a drug review process reeling under chronic, imprudent under-funding of the Food and Drug Administration (FDA) by Congress. PDUFA’s re-authorization in 1997 opened the door for passage of the Food and Drug Administration Modernization Act (FDAMA). This ill-advised law included such anti-consumer protection provisions as the off-label promotion of drugs and its dangerous pharmacy compounding provisions, neither of which remotely relate to the FDA’s drug review process which is the subject of PDUFA. This highlights the dangers to the public of re-opening the Food, Drug and Cosmetic Act (the Act) every five-years giving the drug industry and its paid advocates in Congress the opportunity to play mischief with the Act. The toxic duo of PDUFA-FDAMA has weakened the FDA and for the first time rolled back consumer protection laws that had become progressively stronger during the last century."

MORE AT LINK

Together, the establishment of the CDC's Foundation to accept donations and regulatory changes to the FDA are likely just part of the steps taken to weaponize the medical establishment in the US.

In the past, I had the usual vaccinations and was grateful for them. But today's vaccinations are not the same. Starting around 1994, they began to be associated with increased health problems. Bill Clinton's administration ushered in an entirely new, perhaps strategic, approach to public health and I believe we are seeing  the fruition of those early efforts today.

I don't think it's a coincidence that, in 1994, the CDC's vaccination schedule coorelated with rising illness in the US. (Below is one of many graphs, charts in a legal case found here: https://informedconsentdefense.org/)


Click the image to view our many graphs proving the very high correlation between rising national disease rates and the growing CDC Vaccination Schedule.


 
Click the image for our informational graphic (a demonstrative evidence exhibit) featuring some highlights from our Request for Judicial Notice #3 (“Vaccines Are Made In Communist China”).

We the People have to push back on the CDC, the FDA, and any other arm of the government serving their own interests and betraying the American public.



TOPICS: Miscellaneous
KEYWORDS: covid; covidvaxdeaths; vaccinedeaths; vaccines

1 posted on 05/10/2021 7:26:09 PM PDT by ransomnote
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