This article about FDA responses to Freedom of Information Act (FOIA) requests by anti-vaccine activists was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.
In contrast to anti-vaccine claims (and the headline that echoed them), the FDA responses to a broad Freedom of Information Act (FOIA) requests are not evidence of a conspiracy or some kind of unusual problem (though it may reflect some of the general issues with our FOIA system).
In a recent set of posts by anti-vaccine activists, they criticized FDA for, allegedly, wanting 55 years to process a FOIA request for vaccine data. Unfortunately, some media sources repeated the claim uncritically.
The reality, unsurprisingly, is different. A group that includes several anti-vaccine activists and people who have had anti-vaccine support in the past submitted a very broad request for documents related to the Pfizer-BioNTech vaccine trial.
These documents need to be redacted before being released, to protect interests like patient privacy and trade secrets. The parties are wrangling about the rate at which FDA should process those documents, and the anti-vaccine talking point is basically a misrepresentation of the FDA’s position about the schedule. Here is the report of both parties’ positions to the courts.
FDA explained that this is a very large request, it is one of several hundred they are dealing with, and their FOIA office is small. It wants to provide it at a rate of 500 pages a month, a rate that, from cases cited by FDA, has been repeatedly accepted by courts as reasonable (reflecting standard practice) and has already started providing some of the data. The group is demanding all the information in the next four months. The court will have to decide what is the appropriate rate of release.
To emphasize — at no point did FDA ask the plaintiffs to wait 55 years for documents. The FDA offered to start releasing documents immediately, and work at a rate of 500 pages a month after December 1, releasing 500 pages to the plaintiffs each month – in order of priorities set by the plaintiffs.
This post will examine numerous issues surrounding FOIA requests to the FDA, and whether the responses by the FDA are reasonable or not.
Background
I want to make three background points.
First, as many people who submitted FOIA requests can testify, agencies tend to be… imperfect in their handling of FOIA requests. Requests are often slowly handled. Even though the Freedom of Information Act (FOIA) sets very strict deadlines, agencies often fail to meet them. Agency FOIA teams are often understaffed, and the FDA’s team – consisting of ten people – may be in that category. FOIA is often not a priority.
Agencies also may well redact more than they should. There are often legitimate reasons to criticize agencies’, like the FDA’s, responses to FOIA requests. In this case, too, I cannot be sure the FDA is doing all it can. I can be sure that the anti-vaccine claims misrepresent the case.
Second, the fact that this is a group likely seeking to misuse FOIA to create fear, uncertainty, and doubt about COVID-19 vaccines isn’t relevant to whether the agency should comply with the request and whether it is meeting its FOIA obligations. FOIA is in place to increase government transparency. The motives of the person requesting documents are not relevant to whether they deserve the documents, and whether the agency is meeting its obligations. That’s the law.
Third, in contrast to the way anti-vaccine activists try to present this, it’s not as if we are lacking information about the COVID-19 trials. There is a lot of information about the trials already out, and further, there is a lot more information about the vaccines that don’t depend on Pfizer from the real world.
That said, having more data available about the trials – if this group does in fact make it available to researchers – is certainly a plus. While some group members are likely to misrepresent the trial’s data – and have in the past done just that (group member Dr. Peter Doshi’s previous work on this is a case in point) – having more data about an important clinical trial has real advantages. But we already have good data about the vaccines’ safety and effectiveness, at this point. The CDC has links to some of the studies on the vaccines’ effectiveness and safety easily available online, and there is more.
Since the clinical trial, the vaccines have been given to literally hundreds of millions of people. We have extensive information from all around the world about their safety and effectiveness. That information may not support what the requesters want to believe, but it’s there.
The result of the FOIA requests is unlikely to change the conclusions of experts about the vaccines. More so, since the clinical trial predated the delta variant. It could – and likely will – be used by this group to try to cast doubt on the data.
The Request
The organization requesting the information describes itself as “over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, and Brown.”
A quick look at their list of members shows that they include several people who have actively promoted misinformation about COVID-19 vaccines. These people include Dr. Peter McCullough, who has a history of promoting misinformation about COVID-19 vaccines.
Dr. Peter Doshi, who has made problematic, misleading claims about COVID-19 vaccines trials, as mentioned already. Dr. Bryam Bridle, who did the same. Several of the members have also had work that supported – and was used – by anti-vaccine activists in the past. These include Dr. Tom Jefferson, Dr. Peter Goetzche, Dr. Peter Aaby, and Dr. Christine Stabell Benn.
Benn’s work on non-specific effects on vaccines, to give another example, was misused by anti-vaccine groups. Dr. Benn has recently argued openly for letting – or supporting – children getting sick with COVID-19, something most experts find highly problematic. As a reminder, hundreds of children in the United States died from COVID-19.
The person named first in the group – Dr. Aaron Kheriaty – is a newcomer on the scene, but has already brought two lawsuits against being required to vaccinate for his job as a doctor, against the University of California and the California Department of Public Health. He seems at least sympathetic to anti-vaccine claims – for example, he tweeted implying that the number of unverified reports in the World Health Organization’s VigiAccess database shows that COVID-19 vaccines are dangerous, even though the database warns that the reports cannot be used to present risks directly.
This does not look like a simple group of experts with an interest in the area. It looks to me like a group of people, many of whom are hostile to COVID-19 vaccines, seeking to cast doubt on the vaccines. The fact that they are represented by Aaron Siri, the lawyer representing the anti-vaccine organization ICAN, reinforces that impression, and the way the FOIA request is being used – to try and argue there’s a problem with the data – also supports that.
According to the parties’ joint report in a court case addressing the scheduling of releasing the data, plaintiffs filed a FOIA request requesting “All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51 (e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.”
The relevant section enumerates the following types of data:
(1) All safety and effectiveness data and information.
(2) A protocol for a test or study . . .
(3) Adverse reaction reports. . .
(4) A list of all active ingredients and any inactive ingredients . . .
(5) An assay method or other analytical method . . .
(6) All correspondence and written summaries of oral discussions relating to the biological product file . . .
(7) All records showing the manufacturer’s testing of a particular lot . . .
(8) All records showing the testing of and action on a particular lot by the [FDA].
The FDA described the data requested as comprising at least 329,000 pages. At least, because this count does not include “certain types of records that cannot be meaningfully paginated, such as data captured in spreadsheets that contain thousands of rows of data.” This information cannot be immediately released.
That is because some of it is bound to fall into at least two of the exceptions to FOIA. Some of it is going to include Pfizer’s trade secrets information, and FOIA has an exception for trade secrets. And some of it is going to include private information of trials participants, and that needs to be protected. So FDA needs to go through the material and redact the materials that should not be provided.
To address that, FDA offered to provide certain records by November 17, with other documents by December 1. After December 1, FDA offered to work in order of priority and:
…release the non-exempt portions of those records to the Plaintiff on a rolling basis. FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month. This rate is consistent with processing schedules entered by courts across the country in FOIA cases.
When plaintiffs are saying, as attorney Aaron Siri said in his post in substack, that:
The FDA has asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine. That is not a typo. It wants 55 years to produce this information to the public.
However, that claim is misleading.
It is true that the entirety of the documents, under this schedule, would take decades to provide. But the plaintiffs would start getting documents immediately and get the ones they themselves marked as most important first.
In contrast, the plaintiffs want them to provide the information within less than four months. FDA (through the Department of Justice lawyers that represent the government) explains that doing so “would force FDA to process more than 80,000 pages per month. Undersigned counsel is not aware of any court ever granting such a request.”
The report points out that doing so creates numerous issues.
First, it can lead to information that should be kept private accidentally disclosed. As a reminder, the information includes the private information of trial participants. People who volunteered to be part of the trial deserve better than to have their information given to a group that includes anti-vaccine activists.
Second, FDA pointed out that it does not have the personnel to process the request at the rate requested. The relevant unit processing it is the Access Litigation and Freedom of Information Branch in the FDA’s Center for Biologics Evaluation and Research (CBER), the unit that oversees vaccines. The report says:
The Branch has a total of ten employees, including the director and two trainees. It is currently responsible for processing a total of approximately 400 currently pending FOIA requests, including Plaintiff’s. CBER is currently involved in 6 active FOIA litigation matters. By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources and where fewer requesters’ requests are being fulfilled. Simply put, processing resources are finite. Increasing the volume to more than 80,000 pages per month (if such rate is even possible – and it likely is not), as Plaintiff requests, would result in Plaintiff monopolizing essentially all of FDA’s resources and leaving little resources to process other FOIA requests.
Agencies do have limited resources, and there are other requests. I cannot assess whether 500 is the appropriate number (the report cites cases that found that number reasonable), but the FDA is not avoiding or refusing the request – it’s rationing it compared to the other things on its desk. That’s reasonable, even if the end decision is, say, 700 pages a month instead of 500.
The plaintiffs claimed that:
The FDA is an organization comprised of more than 18,000 people with a budget of $6 billion.18 It has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this vaccine. This request is precisely why the need for transparency is so critical and why Congress enacted FOIA. If the FDA claims its obligations under FOIA are too burdensome, it should take its complaints to Congress – not this Court.
This is not a very good argument. Essentially saying the FDA should stop everything else it is doing and just go over its documents is not very reasonable. FDA was transparent – large amounts of data are easily available online about the vaccine. To give one example, here are the extensive materials provided in preparation for the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on October 26, 2021, about children’s approval – and such an amount of information was made public on each step of the way.
Having more information about the trial is great. Demanding the FDA puts all the other things it is doing on hold to provide this group with 329,000 pages of information that covers ground that is largely covered by existing materials, not so much.
Third, FDA points out that the process of examining a biologics license application is different than the process of reviewing documents for FOIA compliance. This seems obvious, but the reason they needed to say that is that the plaintiffs’ argument was that the time for reviewing the application should be the measure for doing the FOIA review.
Fourth, contrary to plaintiffs’ claims, the regulations – rather than demanding immediate disclosure of all trial data – clarify when it is legitimate to start releasing data. FDA’s argument here is a reasonable interpretation of this language:
After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown…
This is the language in 21 C.F.R. §601.51(e), and it needs to be read in context. Sections b, c, and d prohibit disclosure of information in a file before a license for a product has had issues. S. (e) can be fairly read – as FDA does – to allow disclosure on submitting of a FOIA request and making the information available upon proper redaction, for two reasons.
First, it’s in line with the rest of the section, which makes any information available when a freedom of information act request is submitted (see §601.51(d)(d)).
Second, the Freedom of Information Act has exceptions for a reason, and it’s reasonable not to see the regulation as aiming to disclose, for example, the private medical information of trial participants – and hence, making disclosure contingent on proper redaction, which takes time.
It’s not the only interpretation possible, but it’s a reasonable one, and the reality is that even if it was less reasonable, courts are highly deferential to agency interpretation of their own rules.
Finally, FDA points out that it’s the plaintiffs’ choice to submit such a broad request, and plaintiffs were not inclined to suggest anything they do not want.
Plaintiffs are arguing they need the information because the vaccines are mandated and Pfizer is not liable, under a Public Readiness and Emergency Preparedness Act (PREP), for vaccines harms. But neither claim is convincing.
First, as FDA points out, this is a FOIA case. Not a case about vaccines mandates or liability.
Second, the claim that it’s crucial that this small group of scientists have the information to address vaccine safety is unconvincing. On both the safety and effectiveness, there is extensive data available – much of it published – to assess the vaccines’ safety and effectiveness.
As FDA FOIA documents start being released…
A look at the use the first delivery of data was put to also shows that it’s not clear that the public interest is served by this group’s efforts. On November 17, 2021, the FDA, as it proposed, delivered to the group its first round of FOIA documents, which the group, to its credit, put up on its website.
What is the first use the document was put to? Anti-vaccine lawyer Aaron Siri, who is not a science or public health expert, wrote a post referring to reports submitted to Pfizer.
As a reminder, in a trial like this anything that happened to trials participants would be reported – caused by the vaccine or not. But Siri’s post does not say that and instead tries to present the reports as showing that the vaccines were risky.
If this is an indication of the group’s intentions, the materials are being asked in order for a group seeking to create talking points – and misleading talking points – about COVID-19 to have more ammunition to mislead the public. That’s not actually an important public interest.
To be clear, this problematic intent does not remove FDA obligations under FOIA and does not undermine the group’s right to the data, after redaction. But it does undermine their effort to present their request as serving a goal that the public should support.
One last word. I found some of the coverage of this problematic. For example, this article by Reuters actually does a really nice job, once you get past the first paragraph, of setting out the FOIA issue, even if it does give the group a lot of credit which it might not deserve.
But the heading. And the first paragraph. Those serve exactly the anti-vaccine goal here, and do not capture the actual issue – and many people would stop there.
It’s a disservice to the public to misrepresent this claim in a way that serves anti-vaccine goals.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
