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  • 2022-04-05 (xsd:date)
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  • Pfizer did not bribe the FDA for approval of its COVID-19 vaccine (en)
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  • 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. Several other Twitter users make the same claim . 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. Our ruling 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. (en)
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