Case: 23-10362 Document: 543-1 Page: 47 Date Filed: 08/16/2023
is that the removal of the adverse-event reporting requirement significantly diminishes FDA’s ability to collect this data. Danco’s residual reporting requirements do not cure this APA violation.
C. 2021 Non-Enforcement Decision
We now assess whether the Medical Organizations and Doctors are likely to succeed on their claim regarding the 2021 Non-Enforcement Decision. That decision essentially involves three parts. First, in April 2021, FDA announced that it would temporarily suspend enforcement of the in-person dispensing requirement in light of the COVID-19 pandemic. Next, in December of that year, FDA stated its intent to eliminate the requirement permanently. See 2021 Denial Letter at 25 (“[W]e believe that the Mifepristone REMS Program must be modified to remove the requirement that mifepristone be dispensed only in certain healthcare settings … because this requirement is no longer necessary to ensure that the benefits of the drug outweigh the risks.”). And then in January 2023, FDA amended mifepristone’s REMS, for Mifeprex and the generic, formalizing the change.
FDA supported its decision by pointing to two sources of information. First, the agency examined adverse-events data collected during the period of time when the in-person dispensing requirement was enjoined. FDA obtained this data from FAERS—the voluntary reporting website. 2021 Denial Letter at 26. Danco also submitted its records of adverse events during the relevant interval, but its data set was the same as the one obtained via FAERS. Id. at 27 (“The information provided by the Applicants included the same cases identified in FAERS….”). Five events[1] were reported during that
- ↑ According to FDA, the causes of those events are as follows: ongoing pregnancy, drug intoxication and death, death (unknown cause), sepsis and death, and pulmonary embolism. 2021 Denial Letter at 26.
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