A federal judge recently ordered that the U.S. Food and Drug Administration release Pfizer vaccine data in approximately eight months. This comes after the FDA had requested 75 years to comply with a large public records request.
President Donald Trump appointed Judge Mark Pittman to the agency. He ordered 12,000 pages of Public Health and Medical Professionals for Transparency (PHMPT), by January 31, 2022. Then, 55,000 pages every 30-days. The first round of requests must be submitted by March 1, 2022.
Open government is fundamentally an American issue. It is not a Republican or Democrat issue. James Madison said, “[a] popular government, without popular information or the means to acquire it, is only a Prologue of a Farce, a Tragedy, or both.” Knowledge will always govern ignorance. People who want to be their own governors must equip themselves with the knowledge that gives them.
John F. Kennedy also recognized that “a nation which is afraid to let people judge truth and falsity in an open marketplace is a nation who is afraid of its citizens” John McCain correctly noted that “[e]xcessive administration secrecy is. . . This encourages conspiracy theories and lowers public confidence in the government.
Aaron Siri, PHMPT’s attorney, estimated in court filings that the FOIA request was at least 451,000 pages. This would require approximately 75 years to complete at FDA’s proposed rate 500 pages per month. PHMPT should receive 451,000 documents by October 1, 2022, according to the court-ordered production plan.
Pittman concluded that the request was not burdensome, but that the release of the data is of “paramount” public importance.
PHMPT requested the FOIA from PHMPT. This group includes at least 30 scientists and professors representing universities such as UCLA, Yale, Brown, and Brown. According to the group, it is a non-partisan organization that does not take a partisan view on the data and “exists solely for the purpose of obtaining and disseminating the data relied upon to license COVID-19 vaccinations by the FDA.”
PHMPT filed a lawsuit against the U.S. District Court in the Northern District of Texas in September after the FDA refused to grant an expedited records request of all data relating to Pfizer’s license. According to the group, reviewing the data will resolve the ongoing public debate about the FDA’s review process. PHMPT filed a lawsuit in September against the U.S. District Court for the Northern District of Texas, claiming that receiving the product is a condition of participation in civil society.
Court documents show that Pittman initially asked the FDA to give the agency 55 years to release all data. This was due to the sheer volume of the request. In a December 6 brief, however, the FDA acknowledged that it had discovered tens of thousands more pages of data and 126 additional data files to support the request. This would mean that the 500-page per monthly timeline could be completed in 2096. It is possible that most members of PHMPT will be dead by then.
Pittman acknowledged that a timely order was necessary, and cited court precedent to support his reasoning. He wrote that Congress has long understood that “information is only useful if it’s timely” and that, therefore, any delay by an agency in responding to a request is often tantamount of denial.
The FDA spokesperson stated that they cannot comment on any pending, ongoing or potential litigation.
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