Summary

Prohibits the FDA from approving new applications or allowing investigational use of drugs the bill defines as "abortion drugs," and restricts how already-approved abortion drugs may be labeled, dispensed, and administered. Requires a Risk Evaluation and Mitigation Strategy (REMS) with specific elements (provider certification, clinical capability standards, limits on dispensing and administration, patient acknowledgments, and expanded adverse-event reporting) and creates new reporting duties for health care practitioners; it also provides for rescission of certain previously granted investigational exemptions after three years.

• Prohibits FDA approval of new abortion drugs and bars investigational studies that knowingly destroy an unborn child.
• Places existing approved abortion drugs under strict controls, including a prohibition on labeling that permits use after 70 days' gestation.
• Requires in-person administration by the prescribing practitioner and forbids remote dispensing methods for these drugs.
• Mandates a REMS with minimum elements: practitioner certification, clinical capability standards, limits on dispensing, patient acknowledgment, and enhanced adverse-event reporting.
• Creates new mandatory adverse-event reporting by manufacturers, prescribers, and other health care practitioners (excluding identifiable patient data).
• Preserves the ability of federal and State authorities to impose additional restrictions beyond this law.
• Provides for automatic rescission of previously granted investigational exemptions three years after enactment if they would be barred under the new rule.
• Does not create new spending programs or tax changes in the language provided.