The Washington PostDemocracy Dies in Darkness

Opinion 55 years to fulfill a records request? Clearly, the FDA needs serious reform of its data-sharing practices.

The Food and Drug Administration's inability to provide Freedom of Information Act requests in a timely manner is in need of improvement. (Jacqueline Martin/AP)
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Christopher J. Morten is an associate clinical professor of law at Columbia Law School. Reshma Ramachandran is a physician and fellow within the Yale National Clinician Scholars Program. Joseph S. Ross is a professor of Medicine and Public Health at Yale University. Amy Kapczynski is a law professor at Yale Law School and faculty co-director of the Yale Global Health Justice Partnership and the Law and Political Economy Project.

If the Food and Drug Administration had its way, it would take 55 years or longer to fulfill a Freedom of Information Act request to review and release the vast amount of data it has on the Pfizer/BioNTech coronavirus vaccine.

You read that right. 55 years.

That may sound absurd, but if you’re experienced with FOIA requests to the FDA, as we are, the slow timeline is just more proof that the agency needs a proactive, well-funded data-sharing system to protect public trust and promote scientific research.

The FOIA request, filed in August by a group called Public Health and Medical Professionals for Transparency, seeks essentially all data on the Pfizer vaccine, including all correspondence between Pfizer, BioNTech and the FDA, as well as clinical trial data, manufacturing data and reports of potential side effects.

The FDA responded in November, proposing to produce thousands of high-priority pages by January but then to slow its pace to 500 pages per month. Given the huge scope of records involved, the FDA could take more than half a century to complete production.

As a result, right-wing media aligned with the “anti-vaccine” movement has insinuated a nefarious attempt to hide vaccine data. Republicans in Congress recently introduced legislation to compel the FDA to fulfill the entire request within 100 days.

But this is no coverup. This glacial pace is broadly consistent with the FDA’s standard timelines for fulfilling record requests. The FDA does often prioritize more important documents, but complete responses can take years. The agency’s FOIA office is badly backlogged, with more than 3,000 requests outstanding at the end of 2020. The agency routinely fails to meet response deadlines set by Congress.

As researchers and lawyers, we have experienced such delays firsthand. For example, it took three years and extensive litigation to get the FDA to provide some — not all — of the clinical trial data used to support the agency’s approval of sofosbuvir, a hepatitis C drug, after one of us requested the data with collaborators at the Treatment Action Group.

We have also worked with journalist Charles Seife since 2016 to demand records on eteplirsen, a controversial muscular dystrophy drug. After suing the agency to force production, what we received was heavily redacted. In 2019, a federal court chastised FDA for over-redacting and ordered the production of less-redacted versions. Five years have now passed, and Seife remains embroiled in litigation over the request.

How did FOIA at the FDA become so difficult? Partly because the agency is overwhelmed by commercial FOIA users. Fortune 500 companies use FOIA to gather intel on competitors. Some for-profit specialty companies do nothing but file FOIA requests.

But the FDA’s dysfunction is also self-inflicted, having promulgated unnecessary regulations that designate huge swaths of data as “confidential commercial information.” These self-imposed regulations require painstaking, line-by-line document redaction before the FDA can disclose anything. They require the FDA to err on the side of confidentiality, even though the agency has no actual statutory obligation to do so.

FOIA is a major burden on the FDA, costing the agency $305 million between 2008 and 2017. By comparison, the Center for Biologics Evaluation and Research — the FDA center that evaluates vaccines and hundreds of other vital biologic products — has an annual budget of about $400 million.

There is a better way: The FDA should begin disclosing data, promptly and proactively, whenever it approves a new product, instead of inconsistently disclosing information made in reaction to FOIA requests. As some of us have shown, the FDA already has authority to change its rules and begin disclosing much more information on new approvals.

Rather than undertake line-by-line redaction, the FDA could make some data available in complete or near-complete form, subject to legal and technical constraints on data access and use. Proactive disclosure would permit the FDA to privilege noncommercial data uses likely to serve the public interest.

Proactive data sharing isn’t radical. The FDA’s counterparts in Canada and the European Union are already doing it. In fact, Health Canada has already posted some of the Pfizer vaccine data the researchers are seeking in their FOIA request, belying claims that the vaccine is unsafe.

To be sure, the FDA does proactively disclose some data for new approvals. Yet while these “approval packages” publicize vital information, they also leave some out. The FDA also briefly experimented with a small pilot program that encouraged drugmakers to voluntarily share summaries of clinical trial data, but the program died quietly after only one company volunteered.

Now is the time for the FDA to undertake long-overdue structural reform of its data-sharing practices. The FDA’s sibling agency, the National Institutes of Health, recently announced a laudable new policy of expanded data sharing. The FDA should do the same. Fortunately, President Biden’s nominee for FDA commissioner has voiced support for more proactive data sharing, but he must keep his commitments.

If the FDA doesn’t act, Congress should — not with piecemeal legislation specific to one vaccine or disease, but with legislation that guarantees proactive data sharing for all medical products. The FDA’s work is vital. Reforming its data-sharing practices is essential to combating future vaccine misinformation and preventing public mistrust of the FDA from festering further.