Case: 23-10362 Document: 543-1 Page: 50 Date Filed: 08/16/2023
to perhaps the best source of data: the prescribers. The agency is responsible for its own inability to obtain probative data; it cannot then cite its lack of information as an argument in favor of removing further safeguards. As the motions panel aptly put it: “It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.” All. for Hippocratic Med., 2023 WL 2913725, at *17.
Moreover, considerable evidence shows that FAERS data is insufficient to draw general conclusions about adverse events. Indeed, in describing the database, FDA itself recognizes that “FAERS data cannot be used to calculate the incidence of an adverse event or medication error in the U.S. population.” FDA admits that FAERS reporting is purely voluntary, FDA Br. at 53; consequently, many adverse events will go unreported.
For example, one doctor testified that she obtained adverse-event data from one provider (Planned Parenthood) and compared it to FAERS data for the same time period. For 2010, the provider reported 1,530 adverse events, whereas FAERS reported only 664 events for all providers nationwide. Dr. Harrison Declaration ¶ 17; see also id. (“These discrepancies render FAERS inadequate to evaluate the safety of mifepristone abortions.”).
In addition, the Doctors introduced evidence that many physicians do not use FAERS, either because they are not aware of the system or because they believe that using the system is difficult, and takes time away from their ordinary medical practice:
Many doctors likely do not know about the need to report adverse events related to chemical abortion to the FDA. Similarly, many doctors likely do not know how to report adverse events. … I personally know of practitioners … who have tried to report adverse events related to chemical abortion drugs to the FDA. The process is complicated, cumbersome, and time-consuming. The adverse event reporting require-
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