Original plan would have taken 76 years to produce records
Weeks after a federal judge ordered the Food and Drug Administration to get Americans the data it relied upon when it approved Pfizer’s COVID-19 vaccine, it appears the FDA and Pfizer are balking.
Aaron Siri, the lawyer for the group that sued to have the 450,000 pages of information published sooner rather than later, said the FDA is already objecting to a timetable that called for an accelerated publication schedule to take effect March 1, according to a Wednesday post on his Substack.
Siri said the FDA — which had initially called for publishing 500 pages a month and been told to hit the level of 55,000 pages a month — wants to delay the start of that until May 1.
The FDA’s plan would have taken 76 years to produce the records. The revised plan it was ordered to adopt would get the job done in eight months.
“[A]ll of this insanity is simply in response to an attempt to obtain some basic transparency,” Siri wrote. “This should again bring into sharp focus why the government should never coerce or mandate anyone to get an unwanted medical product or procedure.”
Further complicating the picture is a motion filed by Pfizer to intervene.
“Pfizer supports the public disclosure of the vast majority of this information to promote transparency and the public’s confidence in the vaccine, and Pfizer seeks to intervene for the limited purpose of ensuring that information that is exempt from disclosure under FOIA is not disclosed inappropriately,” the company said in its motion.
“In light of FDA’s statements regarding its capacity to review the requested information at an increased pace, and this Court’s order to produce this information on an expedited basis, Pfizer seeks leave to intervene in this action for the limited purpose of ensuring that information exempt from disclosure under [the Freedom of Information Act] is adequately protected as FDA complies with this Court’s order,” the motion said.
“[T]here is a risk that this matter could result in inadvertent disclosure of FOIA-protected material. Pfizer’s ability to protect its interests would be directly impaired if its trade secrets and other proprietary information were disclosed as a result of this action,” it said.
The FDA said in a court filing Tuesday it welcomed Pfizer’s review. Public Health and Medical Professionals for Transparency, which sued to get the documents released, opposes that intervention.
U.S. District Judge Mark Pittman of the Northern District of Texas, who ruled earlier this month that the FDA should move quickly to produce the documents, was to hold a hearing on Pfizer’s intervention on Friday, Reuters reported.
Siri said the public will lose if Pfizer wins.
“Just look at this circus — the government mandates Pfizer’s product, gives it immunity for any safety or efficacy issues, promotes its product using taxpayer money, gives Pfizer over $17 billion and then uses taxpayers’ money to fight to avoid providing even the most basic level of transparency to the public,” he said.
In his ruling earlier this month, Pittman said the FDA’s initial plan, which would have taken until 2097 to produce all the documents requested, was not good enough.
The judge quoted multiple precedents on the issue of the timely sharing of vital information.
“‘Open government is fundamentally an American issue’ — it is neither a Republican nor a Democrat issue,” Pittman wrote, quoting Republican Sen. John Cornyn of Texas.
“As James Madison wrote, ‘[a] popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which knowledge gives,'” the judge said.
“John F. Kennedy likewise recognized that ‘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.’ And, particularly appropriate in this case, John McCain (correctly) noted that ‘[e]xcessive administrative secrecy … feeds conspiracy theories and reduces the public’s confidence in the government.'”
Pittman recognized in his order that meeting the timetable he had adopted would be a challenge for the FDA, but said the “Court concludes that this FOIA request is of paramount public importance.”
Quoting a comment from a past court ruling that “[S]tale information is of little value,” he wrote that “the expeditious completion of Plaintiff’s request is not only practicable, but necessary.”
He said that “the production rate, as detailed below, appropriately balances the need for unprecedented urgency in processing this request with the FDA’s concerns regarding the burdens of production.”