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Press Releases
Rep. Ralph Norman Introduces Legislation to Expedite FDA Compliance with FOIA Requests for Vaccine Approval Data
Washington, D.C.,
December 2, 2021
On Thursday, Congressman Ralph Norman (R-SC) introduced legislation that would require the Commissioner of the Food and Drug Administration (FDA) to release all records of information submitted to the FDA regarding the authorization of emergency use of, or licensing of all COVID-19 vaccines. The bill requires all records and information to be released to the public no later than 100 days.
Background
The Pfizer COVID-19 vaccine was licensed by the FDA on August 23, 2021, 108 days after Pfizer began submitting documents for approval by the FDA.
The Public Health and Medical Professionals for Transparency (PHMPT) is a group of public health and medical professionals, which includes professors and scientists from universities including Yale, Harvard, UCLA, and Brown.
Through a Freedom of Information Act, PHMPT sought an expedited request "to obtain the data and information relied upon by the FDA to license the Pfizer Vaccine" in part to "confirm the FDA’s conclusion that the Pfizer Vaccine is safe and effective."
The FDA denied expedited processing of PHMPT's request, prompting that organization to file a lawsuit against the FDA in September 2021. In total, PHMPT is seeking more than 329,000 pages of documents detailing the approval of the Pfizer vaccine.
On November 15, 2021, FDA attorneys asked the court to allow the FDA to release just 500 pages per month to the public, resulting in a timeline of roughly 55 years for the disclosure of all documents. More than 256 million doses of Pfizer's vaccine have been administered in the United States since the approval of the vaccine in August 2021 by the FDA.
The FOIA request and lawsuit are exclusive to the FDA approved Pfizer vaccine, but Rep. Norman's legislation would require the public release of all documentation related to Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines.
Rep. Norman issued the following statement on Thursday:
"The FDA's only priority should be the health and safety of consumers. The agency has compromised its integrity by delaying information that belongs to the public. Since the Biden administration is hell-bent on forcing these vaccine mandates on us, the public has every right to know how this vaccine was approved, especially in such a short amount of time. After all, the FDA managed to consider all 329,000 pages of data and grant emergency approval of the Pfizer vaccine within just 108 days. So it’s hard to rationalize why it now needs 55 years to fully release that information to the public."
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