If You Ever Wanted to File a FOI Request with FDA: Forget it.
(Thursday, December 2, 2021)
For those who have tried, sending a Freedom of Information (FOI) request to FDA is like dropping a coin in a wishing well and then hoping for your prayers to be answered. FDA recently provided a rare glimpse into its FOI process in response to a court case and it would come as no surprise as to why FDA is so painfully slow in responding to FOI requests. The case in point was a FOI request filed by Public Health and Medical Professionals for Transparency (PHMPT) to release documents related to the Pfizer Covid vaccine. According to publicly available information, the BLA for the Pfizer vaccine contained about 329,000 pages and many spreadsheets containing thousands of rows of data. The requesters want FDA to release most of these documents under their FOI request. FDA replied that it can at best release about 500 pages per month “on an expedited basis”. That translates to FDA needing about 55 years to release all the pages in the Pfizer application. FDA stated that as required by law it needs to review every page line-by-line and redact proprietary information, a process that must be manually done by its FOI staff. FDA’s FOI Branch in CBER has a total of 10 employees including the director and two trainees. They are currently responsible for processing about 400 FOI requests. You can bet that none of those 400 FOI requests are expected to be fulfilled in the near future. FDA further countered that its FOI staff is not of the same competence as the review staff, and that it is anyway not required to disclose all the information contained in an application under normal circumstances. FDA suggested that the requesters in this case could narrow their request by listing specific documents they desire to see to reduce the burden on the FOI staff and get the documents earlier (earlier than 55 years!). But without knowing what is included in a confidential application, there is no suggestion from FDA as to how the requester would choose what they want to see and what is not as important. While we can argue about the merits of this particular request which seems politically motivated, the case points to the futility of the FOI process in general. FOI requests are presented, by FDA, as the only recourse available to developers seeking more in-depth information on FDA’s past regulatory decisions. While FDA publishes high level summary basis for approval for most drug and biologics it approves, these summaries do not contain intricate details of the development plans and strategies, which could be invaluable to other developers of similar products. The FOI process was created to increase transparency of FDA’s processes but obviously the FOI process is seriously flawed. So, applicants hoping to get any valuable information through their FOI requests, should do the opposite: forget about FOI and employ their resources elsewhere as the FOI request is obviously a canonical black hole from which information rarely escapes.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC