Attorney General Merrick Garland has announced that Biden administration “strongly disagrees” with the Fifth Circuit’s partial denial of its request for a stay pending appeal and will seek emergency relief from the Supreme Court “to defend the FDA’s scientific judgment.”

But what the Fifth Circuit ruled is that the FDA had failed to carry its burden (as the procedural posture of its emergency motion requires) of showing that its actions with respect to the 2016 Major REMS Changes were not arbitrary and capricious.

The Fifth Circuit’s critique of the FDA’s supposed “scientific judgment” is devastating and rests on elementary logic, not arcane science:

First, FDA failed to “examine the relevant data” when it made the 2016 Major REMS changes. That’s because FDA eliminated REMS safeguards based on studies that included those very safeguards. Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts. For nearly a decade, the agency collects those studies and continues studying how cars perform with passive safety measures. Then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures. That was obviously arbitrary and capricious in [1983 Supreme Court ruling in] State Farm. And so too here. The fact that mifepristone might be safe when used with the 2000 Approval’s REMS (a question studied by FDA) says nothing about whether FDA can eliminate those REMS (a question not studied by FDA).
True, FDA studied the safety consequences of eliminating one or two of the 2000 Approval’s REMS in isolation. But it relied on zero studies that evaluated the safety-and-effectiveness consequences of the 2016 Major REMS Changes as a whole. This deficiency shows that FDA failed to consider “an important aspect of the problem” when it made the 2016 Major REMS Changes.
Second, the 2016 Major REMS Changes eliminated the requirement that non-fatal adverse events must be reported to FDA. After eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is “safe.” This ostrich’s-head-in-the-sand approach is deeply troubling—especially on a record that, according to applicants’ own documents, necessitates a REMS program, a “Patient Agreement Form,” and a “Black Box” warning. And it suggests FDA’s actions are well “outside the zone of reasonableness.” 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.

(Italics in original; underlining added; various citations omitted.)

(Disclosure.)