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U.S. Rep. Ralph Norman (R-S.C.) on Thursday introduced legislation that would require the U.S. Food and Drug Administration (FDA) to release, within 100 days, all records of information submitted to the agency regarding the Emergency Use Authorization of, or licensing of all Pfizer COVID-19 vaccines.
The legislation stems from the FDA’s appeal to delay — by up to 55 years — the release of documents requested in August, under the Freedom of Information Act (FOIA), by the Public Health and Medical Professionals for Transparency (PHMPT).
PHMPT, a group of more than 30 scientists, medical professionals, international public health professionals and journalists, asked the FDA for “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports and a list of active and inactive ingredients.
In September, PHMPT sued the FDA, in the U.S. District Court for the Northern District of Texas, for failing to respond to the FOIA request.
Norman called the FDA’s request to delay release of the documents “the beginning of a very bad joke.”
In a statement, Norman said:
“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.”
“Hiding the data for 55 years is the opposite of transparency,” Kennedy said. “It’s no wonder Americans no longer trust these vaccines or the governmental agencies that regulate them.”
PHMPT’s lawsuit referenced the Aug. 23 approval of Pfizer’s Comirnaty COVID vaccine for individual 16 and older. The lawsuit alleges that while the FDA claims the vaccine “meets the high standards for safety, effectiveness and manufacturing quality,” medical experts and others have questions regarding the data.
According to the complaint:
“The medical and scientific community and the public have a substantial interest in reviewing the data and information underlying the FDA’s approval of the Pfizer Vaccine. Reviewing this information will settle the ongoing public debate regarding the adequacy of the FDA’s review process. Releasing this data should also confirm the FDA’s conclusion that the Pfizer Vaccine is safe and effective and, thus, increase confidence in the Pfizer Vaccine.
“The public’s need for this information is urgent given the fact that COVID-19 vaccines are being mandated to individuals across the country by federal, state and local governments as well as private businesses.”
The FDA responded on Nov. 15 stating there are more than 329,000 pages of documents, which would require the agency to process more than 80,000 pages a month to fulfill the FOIA request.
The FDA asked to be allowed to provide 500 pages a month, which would mean 658 months — or just under 55 years — for the full release.
The FDA said that from its experience with other FOIA requests, “such records can be expected to contain both confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.”
The FDA said it’s a “specious argument” that the process to release documents can be done in the same timeframe it took the FDA to review the documents for the approval of Pfizer’s COVID vaccine — as the agency has only 10 employees who process FOIA requests.
In its response, the FDA said:
“Increasing the volume to more than 80,000 pages per month (if such rate is even possible — and it likely is not), as Plaintiff requests, would result in Plaintiff monopolizing essentially all of FDA’s resources and leaving little resources to process other FOIA requests. Indeed, the D.C. Circuit has recognized that another agency’s policy of processing 500 pages per request per month ‘serves to promote efficient responses to a larger number of requesters.’”
Redactions raise questions about what FDA deems ‘confidential,’ attorney says
Aaron Siri, one of the lawyers representing PHMPT, said the lawsuit was filed in September after the FDA “produced nothing” from the August FOIA request.
Siri wrote on his Injecting Freedom Substack page:
“So, let’s get this straight. The federal government shields Pfizer from liability. Gives it billions of dollars. Makes Americans take its product. But won’t let you see the data supporting its product’s safety and efficacy. Who does the government work for?
“The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure. Everyone who wants to get vaccinated and boosted should be free to do so. But nobody should be coerced by the government to partake in any medical procedure. Certainly not one where the government wants to hide the full information relied upon for its licensure until the year 2076!”
In a Nov. 19 blog post, Siri wrote that the first 91 pages had been produced. However, some information was redacted, raising questions about what the FDA views as “confidential.”
“Pfizer explains, on page 6, that ‘Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritized the processing of serious cases …’ and that Pfizer ‘has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports’ including ‘increasing the number of data entry and case processing colleagues’ and ‘has onboarded approximately [REDACTED] additional full-time employees (FTEs).’”
Siri also asked why it would be proprietary to share how many people Pfizer had to hire to track all of the adverse events being reported shortly after launching its product.