FDA Rep a No-Show at Court Hearing, Citing COVID Concerns; FDA Releases Additional Docs; and FDA Triples Down On 75-Year Production
By Aaron Siri
A few updates on the battle to get FDA to release the licensure documents for Pfizer’s vaccine, which will hopefully address most of the inquiries on this matter:
1. The FDA incredibly failed to send a representative to a federal court hearing in this matter on December 14th because of the “FDA’s protocols” regarding COVID-19. Meaning, despite the federal health agencies’ compliance rate with its mandatory vaccination policy of over 98.8% and its resounding claim that the vaccines are “effective,” the FDA is apparently still scared. Its actions speak volumes and cast serious doubt on its words.
2. Just prior to the Court hearing, the FDA released additional documents. These included a report on vaccine safety and a report on vaccine efficacy. There are many notable portions, but we will leave that to the scientists to analyze noting that, as the experts in the plaintiff’s group have explained, adequate analysis of the vaccines’ safety and efficacy is nearly impossible to complete without the full universe of documents.
3. Contrary to what has been reported elsewhere, there has been no decision issued in this case yet and any documents produced to date have been produced by the FDA apparently in the hopes of softening any decision the Court may render.
4. Regarding the hearing this week, the public will get to read the transcript when it is released, which we expect should be soon. In the meantime, it is noteworthy that the DOJ attorney who appeared without an FDA representative effectively argued that the American people and the plaintiff should just trust the FDA that it will produce documents as fast as possible even though it has now been over 110 days since the request was made to the FDA and it has produced on average only ~29 pages per day. The FDA also continued to maintain that it does not want the Court to require it to produce at a rate faster than 500 pages per month as it continued to harp on Pfizer’s interests and its trade secrets, for the most part ignoring the interests of the American people. For our part, we had the privilege of arguing many of the points that you can read below in our papers.
There is one point that is particularly noteworthy: Americans must routinely produce documents, pay fines, and otherwise expend resources to comply with the law. Courts don’t inquire as to the ability or financial resources to comply with the law – they must comply. In fact, it would be laughable if a billionaire defendant came before a court and claimed poverty to escape making a document production, but that is the FDA’s position. The Court, we hope, will do what it does with all parties: enter an order requiring the FDA to follow the law. If the FDA has an issue with doing so, it should take its complaint to Congress, not ask the Court to deviate from the law or give it any special accommodation from compliance with the laws that every other American must comply with.
(A more granular point for those interested: the FDA also argued that the Court cannot consider all of the evidence presented by the plaintiff in its papers because it is limited to consider only the record that was before the FDA when the agency initially denied the plaintiff’s request for expedited processing. The FDA must appreciate, however, that that rule only applies to deciding expedition – it does not apply to deciding the rate of production. The case law is clear on that point. Obviously, if that limitation did apply to the rate of production, none of the declarations submitted by the FDA could be considered by the Court. 266 F. Supp. 3d 241. In any event, even with regard to deciding expedition, numerous courts have held that they can rely on their equitable powers to consider documents outside the administrative record. 910 F. Supp. 2d 270, 274-75.)
5. As previously posted, the parties filed dueling opening briefs on December 6, 2021. On Monday, December 13, 2021, the parties filed dueling reply briefs. Below is a copy of the introduction from the December 13 brief responding to the FDA’s argument, and full copies of the parties’ December 13 papers are linked at the end of this article.
INTRODUCTION FROM PLAINTIFF’S REPLY BRIEF OF DECEMBER 13, 2021
Defendant, incredibly, focuses its opening brief on the idea that fairness requires it to take decades to produce the Pfizer vaccine licensure documents. Fairness? Fairness would be giving millions of Americans who are mandated to receive this liability-free vaccine today assurance regarding the FDA’s review by allowing independent scientists access to the same data the FDA reviewed, without making them wait decades. Fairness would be allowing Americans injured by the vaccine today, who cannot sue Pfizer or anyone else for the harm, hope that independent scientists with access to that data can more readily develop treatments for their ailments. Fairness would be our federal health authorities allocating more than one person spending a few hours each month to review Pfizer’s documents for public disclosure after having given Pfizer over $17 billion of taxpayer money to develop and market the product. Fairness would be releasing the documents so that independent scientists can have this data to assist in addressing serious issues of waning immunity, diminished efficacy, vaccine-immunity evading variants, etc. Fairness would be producing documents that the American taxpayers paid for while those same people are still alive, not decades after most are dead. That would be fair to the American people.
All of the FDA’s griping about fairness comes down to one thing, and one thing alone: it has not sufficiently staffed its FOIA office to properly meet its legal obligations to respond to the requests it receives. In passing FOIA, Congress made the policy decision that it wanted to ensure transparency, and it knew that transparency delayed is transparency denied, therefore it required agencies like the FDA to produce documents as soon as practicable where the request qualifies for expedited processing. That is the FDA’s legal obligation: to promptly produce records. The FDA is not permitted to thwart Congress’ policy choice by understaffing its FOIA response office. Numerous cases show how other agencies, when dealing with a production that is eligible for expedited processing, have transferred staff, or hired more staff, in order to promptly comply with its statutory obligations. Here, for the reasons explained in PHMPT’s opening brief, the instant FOIA request is the prime example of one that requires expedited processing, and as a result, the FDA cannot be heard to claim that it has too few people to meet its statutory obligations.
Law journal articles, ABA publications, and legal decisions all reflect a document review rate of at least 50 pages per hour per reviewer, and often far more, for reviewing documents for production in litigation – where those reviewers are also searching the documents for relevance, responsiveness, privilege, hot documents, confidentiality designations, attorney-eyes only designation, trade secrets, certain personal information, coding by category, etc. Those are tasks far more complex than called for here. For the simpler task of reviewing for only personally identifiable information and trade secrets under FOIA, assuming a low average of 50 pages per hour per person, even to review the hundreds of thousands of pages the FDA estimates, the agency would need just 19 reviewers to work full time for 12 weeks to review and produce these documents – which is a tiny fraction of its approximately 18,000 employees or, if it outsources the review as is common in litigation reviews, a mere rounding error in its approximately $6.5 billion budget and an even smaller rounding error of the over $17 billion given by the federal government to Pfizer. Plaintiff, in fact, obtained a quote from the e-discovery company BIA dated December 10, 2021 to conduct this precise review of 400,000 pages. BIA concluded that the review could be completed in a period of 6-8 weeks with 10 reviewers and 1 team leader for a total price tag of approximately $132,000. The FDA should be directed to do precisely that. It should do what everyone else in this country must do – follow the requirements of federal law.
Companies do not get to delay paying taxes because they don’t have enough tax personnel. They don’t get to avoid complying with environmental regulations because they don’t have enough compliance officers. They don’t get to avoid responding to a U.S. Attorney’s subpoena because they don’t have enough staff to review the documents. They must follow the law, and so must federal agencies. And here the law says “promptly” and “as soon as practicable,” and the regulation says, “immediately available.” All of this statutory and regulatory language is intended to ensure transparency. These requirements are utterly defeated if the documents are not produced forthwith. Waiting for transparency until almost everyone alive today is dead makes a mockery of FOIA and of the promise of transparency.
Showing just how misguided the FDA is in its approach, in its brief and declaration in support of same, the FDA ignores all the arguments made by Plaintiff with regard to fairness in the parties’ First Joint Report and Second Joint Report. It ignores the incredible unfairness to the American people to not have access to the Pfizer documents.
Instead, the FDA repeatedly discusses in its motion papers what is fair to the vaccine sponsor, meaning Pfizer, and “the interests of the vaccine sponsor.” Putting aside that this is not a real concern in this case, if Pfizer is concerned about its trade secrets, then it has more than sufficient resources to perform the necessary review and inform the FDA what it believes should be withheld from disclosure in a timely manner. This is not a novel concept as other FOIA matters have been resolved in this manner wherein the FDA has adopted redactions proposed by the creator of the documents based on the company’s representations that the documents covered confidential commercial information that would cause harm if disclosed. In fact, if Pfizer spent just .01% of the $17 billion in taxpayer money it received from the federal government for its liability-free mandated product, it could complete this review in less than a week. At a minimum, Pfizer’s interests must be viewed through the lens of its obligation to the American people who are underwriting its profits for a product the government has marketed for Pfizer, given immunity from harm, and mandated American take under penalty of exclusion from civil society.
The FDA also says it is unfair to other pending FOIA requesters to prioritize this request. First, since this request qualifies for expedited processing, it must by statute take priority over all other requestors. Second, any unfairness to other requestors is outweighed by the interest of millions of Americans who are being affected by the Pfizer vaccine in having independent scientists review the Pfizer data. Third, any unfairness falls squarely on the shoulders of the FDA for choosing, even now during a pandemic, to only have 10 people in its FOIA office (only 8 of whom with experience) despite a budget of over $6.5 billion and over 18,000 employees. Regardless of whether the FDA has made FOIA or transparency a priority, it is an obligation imposed by law and one that must be upheld by the courts despite any claimed hardship it may impose. For the hardship suffered by the American people in the alternative far outweighs any felt by the agency.
PHMPT Opposition Brief & Appendix:
FDA Opposition Brief & Appendix:
Source: Originally published on Substack.
