Did Pfizer pay a US$2.8 million bribe to the FDA for the approval of their COVID-19 vaccine?!
Take a look at the new viral claim, and find out what the facts really are!
Claim : Pfizer Paid $2.8 Million Bribe For FDA Vaccine Approval!
People are sharing a screenshot of a Pfizer document, calling it evidence that they paid the FDA a US$2.8 million bribe for the approval of their COVID-19 vaccine!
Truth : Pfizer Did Not Pay $2.8 Million Bribe For FDA Vaccine Approval!
This is yet another piece of anti-vaccination FAKE NEWS based on the Pfizer documents released by the FDA, and here are the reasons why…
Fact #1 : It Was A Cover Letter
First of all, you should read the entire letter in full. You can download the copy provided to PHMPT on 1 March 2022.
You will note that it is a 6-page cover letter for the Rolling Biologics License Application (BLA) request for Priority Review Designation submission.
Fact #2 : Sentence Was Truncated
Instead of posting the entire letter so you can read it, they shared the first page, with a single truncated sentence highlighted.
If they posted the complete sentence, you would have read that the $2.8 million dollars was for “the user fee for this application“.
No wonder they cut off that part…
Fact #3 : $2.8 Million Was Standard FDA Application Fee, Not Bribe
What these anti-vaccination activists don’t want you to know is that the $2.8 million was not to bribe the FDA into approving their COVID-19 vaccine.
The truth is – Pfizer was paying the standard FDA user fee of $2.8 million for a “human drug application” with clinical data required.
When Pfizer submitted their application in May 2021, the FDA user fee was $2,875,842 – the exact amount stated in their cover letter. That actually increased to $3.1 million in 2022.
On top of that, pharmaceutical companies have to pay an additional Program Fee, which was $336 thousand in 2021, and just under $370 thousand in 2022.
|FDA User Fee||2021||2022|
|Application Fee (With Clinical Data)||$2,875,842||$3,117,218|
|Application Fee (No Clinical Data)||$1,437,921||$1,558,609|
Fact #4 : $2.8 Million Fee Was Required By Law
The $2.8 million fee was actually required by law, specifically the Prescription Drug User Fee Act (PDUFA), that the US Congress enacted in 1992.
The PDUFA provides that the FDA is entitled to collect the application fee from pharmaceutical companies that submit a New Drug Application (NDA) or Biologics License Application (BLA) application.
Read more : Is Pfizer Delisting Itself On Nasdaq + NYSE?!
Fact #5 : FDA Fee Only Used For Review + Approval
The funds is designated to be used only for the review and approval process of the NDA or BLA applications.
Since it was enacted in 1992, PDUFA funds have allowed the FDA to greatly increase staffing to expedite the time it takes to review each new drug or vaccine.
In fact, the FDA is required to meet certain performance benchmarks, in order to continue collecting these fees.
In other words, Pfizer did not pay the FDA to approve their vaccine. They paid the Congress-mandated fee, to fund the expedited review of their COVID-19 vaccine… just like all other pharmaceutical company applying for FDA approval.
Fact #6 : FDA Fee Had Nothing To Do With Priority Review
Under the Prescription Drug User Act (PDUFA), the FDA has a two-tiered review system – Standard Review and Priority Review.
The payment of the PDUFA user fee does not grant any application a Priority Review designation. All NDA / BLA submissions to the FDA incur the same user application fee.
Pharmaceutical companies can request for priority review, but it is up to the FDA to review and designate whether an application should receive a Standard Review, or a Priority Review.
Fact #7 : Priority Review Based On Need + Urgency
The FDA decides which application gets a Priority Review, based on whether the drug / vaccine could potentially offer “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications“.
Based on that criteria, the FDA granted the Pfizer COVID-19 vaccine a Priority Review on 16 July 2021 – just over 2 months after they applied for the Priority Review.
This had nothing to do with the payment of the application fee, which was paid in advanced more than two months earlier.
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