Kyle Faget discusses FDA’s mifepristone safety review and the Louisiana v. FDA litigation with Inside Health Policy

In a recent Inside Health Policy article, Kyle Faget discusses what FDA’s status report on its mifepristone safety assessment could mean for the Louisiana v. FDA case, which seeks to reinstate in-person requirements for the drug and could upend telehealth access to abortion pills.

Kyle explained that FDA would need to find safety signals to justify rolling back the current REMS to in-office dispensing, and that the agency will face pressure from both sides of the abortion debate whatever the review concludes. She also questioned whether the incoming FDA commissioner will push to speed up the process as political pressure builds. If the review finds no new safety signals and the prescribing requirements stay the same, Kyle noted, the case would turn on a larger question: what a single state can do to challenge FDA’s regulatory framework with nationwide effect.