HomeLatest NewsUS judge gives FDA 8 months to produce Pfizer safety data

US judge gives FDA 8 months to produce Pfizer safety data

The U.S. Food and Drug Administration will have eight months — not the 75 years it requested — to release all documents related to the licensing of Pfizer’s Comirnaty COVID vaccine, a federal judge ruled

Washington: The U.S. Food and Drug Administration (FDA) will have eight months — not the 75 years it requested — to release all documents related to the licensing of Pfizer’s Comirnaty COVID vaccine, a US federal judge ruled on 8th January 2022.

In his ruling, Judge Mark Pittman of the U.S. District Court for the Northern District of Texas, quoted President John F. Kennedy, writing, “a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”

Judge Pittman rejected the FDA’s claim that it could release redacted versions of documents at a rate of only 500 pages per month, which would have meant the full cache of documents wouldn’t become public until 2096.

The documents in question relate to a Freedom of Information Act (FOIA) request filed in August 2021 by Public Health and Medical Professionals for Transparency (PHMPT), a group of more than 30 medical and public health professionals and scientists from institutions such as Harvard, Yale, and UCLA.

In his four-page order, Judge Pittman ordered the FDA to produce more than 12,000 pages of documents on or before Jan. 31, and thereafter to “produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.”

According to this timeline, the almost-400,000 pages of documents will have been made public, sans redactions, within eight months, rather than by the year 2097.

In its FOIA request, PHMPT asked the FDA to release “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.

PHMPT had initially requested expedited processing of its FOIA submission on the basis there is a “compelling need” for the swift release of the documents in question, further arguing that the documentation should be fully released within 108 days — the number of days it took the FDA to approve Pfizer’s vaccine.

When the organization’s request was rejected by the FDA, PHMPT filed a lawsuit against the agency.

The FDA, in its argument, recognized that it had an “obligation” to make the information public, but claimed its Center for Biologics Evaluation and Research, which maintains the records in question, has only 10 staff members, two of whom are “new.” Web Desk

 

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