FDA Cannot Have Until 2076 to Disclose Pfizer/BioNTech Vaccine Data
Published at : January 15, 2022
A U.S. federal judge in Texas has denied attempts by the U.S. Food and Drug Administration (FDA) to conceal data on Pfizer’s COVID-19 vaccine. The judicial rule overturned the regulatory agency’s plan to withhold data for up to 55 years. Judge Napolitano breaks it all down.
#Pfizer #COVID #FDA
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The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization. In its lawsuit, which was filed in September, the PHMPT claimed that under federal law, the data and information in the biological product file that was submitted to the FDA are expected to be available for public disclosure unless extraordinary circumstances have been shown. The judge presiding over the lawsuit agreed.
U.S. District Judge Mark Pittman found that the Freedom of Information Act filed by PHMPT “is of paramount public importance.” The judge’s ruling demands that the FDA make the data publicly available within a span of eight months.
The FDA has not disputed that the data should be made available to the public. However, the regulatory agency has claimed that each page of the file must be closely reviewed in order to redact confidential details or trade secrets that could be exposed.
#Pfizer #COVID #FDA
More from BioSpace:
The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization. In its lawsuit, which was filed in September, the PHMPT claimed that under federal law, the data and information in the biological product file that was submitted to the FDA are expected to be available for public disclosure unless extraordinary circumstances have been shown. The judge presiding over the lawsuit agreed.
U.S. District Judge Mark Pittman found that the Freedom of Information Act filed by PHMPT “is of paramount public importance.” The judge’s ruling demands that the FDA make the data publicly available within a span of eight months.
The FDA has not disputed that the data should be made available to the public. However, the regulatory agency has claimed that each page of the file must be closely reviewed in order to redact confidential details or trade secrets that could be exposed.
CannotUntilDisclose