FDA Resists FOIA Request for Vaccine Approval Info as Biden Administration Offers to Share it with the World


“At this very moment, the Biden Administration is supporting a radical proposal by the governments of India and South Africa to waive patent and trade secret rights relating to COVID-19 vaccines. Yet, the Biden Administration itself is telling a federal district court judge that it is not feasible to release documents relating to the Pfizer COVID-19 vaccine approval.”

https://depositphotos.com/471450802/stock-photo-global-covid19-vaccination-strategy-concept.htmlFrom the “one hand doesn’t know what the other hand is doing” category, believe it or not, the Food and Drug Administration (FDA) is effectively refusing to release documents it possesses relating to the approval of the Pfizer-BioNTech COVID-19 vaccine.

More precisely, Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and scientists, submitted a Freedom of Information Act (FOIA) request for documents relating to the approval of the Pfizer COVID-19 vaccine. After the FDA denied a request by the PHMPT to expedite release of the documents, a lawsuit was filed. In response to that lawsuit, the FDA proposed to release 500 pages per month, which would allow the agency time to redact material as necessary. Given that there are 329,000 pages responsive to the PHMPT request, at the proposed FDA rate of 500 pages per month it would take 55 years for the FDA to fully release the Pfizer COVID-19 vaccine documents.

Oh, the irony! At this very moment, the Biden Administration is supporting a radical proposal by the governments of India and South Africa  to waive patent and trade secret rights relating to COVID-19 vaccines. Yet, the Biden Administration itself is telling a federal district court judge that it is not feasible to release documents relating to the Pfizer COVID-19 vaccine approval. If I were the district court judge, there would be some explaining necessary. Why does the Biden Administration support the entire rest of the world getting access to Pfizer’s exclusive rights and trade secret information while it can’t be bothered to release its own information at a rate of more than 500 pages a month and over a period of more than two generations?

Frankly, it seems as if the Biden Administration is fine with requiring innovators to turn over their work product to direct and future competitors at the behest of WTO Member Countries but is fighting to protect FDA work product from the public. Whether incompetence or ignorance, the desire of the FDA fight to slow walk the release of COVID-19 vaccine documents while redacting confidential information along is the very definition of hypocrisy. Apparently, what is good for the goose is not good for the gander.

Let’s Review this Bad Idea

Let’s take a step back. The Indian and South African proposals relate to the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property (TRIPS). The proposals by South Africa and India in question are to waive patent and trade secret protections relative to COVID-19 innovations, which would allow countries to require companies with IP rights relating to COVID-19 to forfeit those exclusive rights.

While at first blush that might seem like a laudable proposal, the research and development of COVID-19 vaccines has been going on for nearly two decades, making whatever the general public has been told by popular media outlets simply inaccurate. Indeed, pharmaceutical and biotech companies that have been researching and developing the technology behind these vaccines since at least 2003. See e.g. Settings for recombinant adenoviral-based vaccinesU.S. Patent No. 7,598,078 (filed by Crucell Holland B.V. in 2003 and later acquired by Johnson & Johnson). So, when it is said that governments paid for the development of COVID-19 vaccines, that is simply incorrect.

Even if the TRIPS waiver were to be implemented, there are serious questions about what a waiver would mean. For example, would a waiver mean going back nearly 20 years and requiring all of the innovation that led up to the COVID-19 vaccines to be forfeited, or just the ultimate innovation?  So many details will need to be worked out that by the time there is a workable framework, COVID-19 will be endemic, not a pandemic.

A Very Good Question

Perhaps most ironic is that the proposed TRIPS waiver does not apply only to patents, but also to trade secrets. So, as the FDA argues that they need time to redact documents prior to release under FOIA, but if the TRIPS waiver is agreed to by Member Countries of the WTO it is doubtful there be the ability for pharmaceutical or biotech companies to redact secret or confidential information.

Presumably, countries that would be so inclined to compel disclosure of trade secret information would do so as a contingency to market access, but who knows for sure the extent of the intrusion into the several decades of research and development that went into COVID-19 vaccines. What we do know, however, is that once extraordinarily valuable trade secret information is disclosed it will be passed along to foreign entities that are direct or future market competitors to U.S. innovators who developed this technology. This is worse than a compulsory licensing regime. If the TRIPS waiver is approved, it will be an enormous transfer of technology from innovators who have invested massive amounts of time and money to create to free riders who have done nothing but will still reap a windfall. It will be theft of innovation.

So, exactly why is the FDA functionally refusing to disclose documents while the Biden Administration is arguing at the WTO that companies like Johnson & Johnson, Moderna and Pfizer will presumably have to disclose that same or similar information without any redaction to all signatories to TRIPS? That is a very good question, and one that will be very difficult to answer if it is asked in the proper forum by someone – like a judge – who can demand an answer.

Gene Quinn

Gene Quinn

is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded IPWatchdog.com in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. Gene is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.



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