Bill would restrict abortion drug approvals, access, and research

The FDA would be barred from approving applications to market abortion drugs. The ban covers drugs or substances intended or actually used to intentionally end a known pregnancy, regardless of their labels. The definition excludes drugs intended to produce a live birth, remove an embryo or fetus that has died, or treat a pregnancy outside the uterus.

The FDA would require prescription-only access and a safety plan for covered abortion drugs. These requirements cover abortion drugs with approval in effect when the bill becomes law. Certified prescribers would need pregnancy assessment and emergency care abilities and could not act as pharmacists. Patients would receive written risk information and acknowledge receiving it. Manufacturers and health care providers would report harmful events without identifying patients. For drugs approved when the bill becomes law, the FDA could not approve label changes allowing use beyond 70 days of pregnancy or dispensing without in-person administration by the prescriber.

The FDA would be barred from granting certain permissions to use drugs in research. The restriction covers abortion drugs and investigations that knowingly destroy an embryo or fetus of a woman known to be pregnant. An earlier research permission would end only if the bill's restrictions would prohibit granting it at the three-year mark. The three-year deadline applies to research permissions granted before the bill becomes law.