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The Prescription Drug User Fee Act was passed in 1992 and allows the FDA to collect fees from drug companies seeking approval of products.
The fees provide funding that helps the agency speed the review and approval process, the FDA said.
Spokespersons for Pfizer and the FDA confirmed the payment was for the fee required under the law.
Some social media users are falsely describing a document showing a $2.8 million payment from Pfizer to the U.S. Food and Drug Administration as a "bribe" for approval of the company’s COVID-19 vaccine.
"$2.8 million bribe payment from Pfizer to FDA for their Bioweapon ‘approval.’ You’re not supposed to know that. Look the other way," reads an April 2 tweet.
The tweet includes a photo of a document with a line at the bottom that reads: "A wire transfer of $2,875,842.00 was made to the U.S. Department of Treasury. (TREAS)," before cutting off.
The payment was not a bribe, but rather an application fee required under a 30-year-old law for any drugmaker seeking FDA approval of their products.
The Prescription Drug User Fee Act was signed into law in 1992 and has been reauthorized every five years. It allows the FDA to collect fees from pharmaceutical companies "that produce certain human drug and biological products," and helps the agency streamline the approval process, the FDA website says. (The law is due for reauthorization again this year.)
"User fees provide instrumental funding for the FDA’s independent review of medical products that make a difference in the lives of all Americans, without compromising the agency’s commitment to scientific integrity, public health and regulatory standards, patient safety, and transparency," FDA spokesperson Abby Capobianco wrote in a statement to PolitiFact.
The FDA’s fiscal year 2021 budget was $6.1 billion. Industry user fees paid about 46% of the budget; the federal budget authorization covered the other 54%.
A spokesperson for Pfizer also confirmed that the $2.8 million mentioned in the tweets was a required Prescription Drug User Fee Act payment.
The FDA released the document as part of an ongoing Freedom of Information Act lawsuit, said Capobianco.
The lawsuit seeking the documents came from a group called the Public Health and Medical Professionals for Transparency. That group, which MedPage Today reports has several members known for spreading false information during the pandemic, sued the FDA in September for the release of COVID-19 vaccine review documents.
The photo shared by some on social media only shows the first page of the six-page document, and ends in mid-sentence, cutting off the portion that states the payment is for a "user fee."
The payment shown in the May 6, 2021 document, matches the 2021 rates posted on an FDA webpage for applications that are required to present clinical data.
In August 2021, the FDA gave Pfizer’s COVID-19 vaccine full approval for use in people ages 16 and older. "The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," then-Acting FDA Commissioner Janet Woodcock said in August.
Social media users are saying a document recently released by the FDA shows that Pfizer paid the agency a $2.8 million "bribe" for approval of its COVID-19 vaccine.
But those posts mislead by sharing a truncated version of the letter that describes a user fee. Those fees are paid to the FDA under the Prescription Drug User Fee Act. All drug companies must pay the fees to have their products reviewed for approval.
We rate this claim False.
FDA, "Prescription Drug User Fee Amendments," updated Feb. 15, 2022
FDA, "PDUFA Legislation and Background," Dec. 15, 2015
FDA, "Fact Sheet: FDA at a Glance," Nov. 18, 2020
FDA, "CDER’s Work to Meet User Fee Goals During the Pandemic," Feb. 17, 2022
MedPage Today, "FDA Begins Releasing Pfizer COVID Vax Documents," March 7, 2022
Statement from Pfizer spokesperson, April 5, 2022
Pfizer press release, July 16, 2021
TechArp, "Did Pfizer Pay $2.8 Million Bribe For FDA Vaccine Approval?!" March 24, 2022
Public Health and Medical Professionals for Transparency, Pfizer letter to FDA
Michael Gabay, "The Prescription Drug User Fee Act: Cause for Concern?" April 2018
The Conversation, "Why is the FDA funded in part by the companies it regulates?" May 13, 2021
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