NOTICIAS

On January 3, 2023, the U.S. Food and Drug Administration (FDA) began allowing pharmacies, including mail-in services, to distribute the chemical abortion pill mifepristone with no in-person distribution requirement. Data shows mifepristone is dangerous, which is why women were previously required to use the drug under medical supervision.

On January 31, U.S. Senator Marco Rubio (R-FL) and U.S. Representative Andrew Clyde (R-GA) sent a letter to the Government Accountability Office (GAO) arguing the FDA’s new guidance may constitute a “rule” and thereby be subject to Congressional review under the Congressional Review Act (CRA).

GAO has yet to respond with its conclusion. Meanwhile, after careful consideration, Rubio and Clyde have determined the FDA’s new guidance does indeed constitute a “rule,” and that by failing to submit a report to Congress, the FDA violated the CRA. They sent their analysis to GAO in a letter.

• “We believe the FDA’s updated REMS for mifepristone is a ‘rule’ under CRA because it has general applicability; has future effect; implements or prescribes law or policy; and is not subject to the limited exceptions to a ‘rule’ defined by the CRA because it is not a rule of particular applicability; it does not relate to agency management/personnel; and it substantially impacts the rights and duties of non-agency parties.”

• “The FDA did not submit this policy to Congress and we believe it is imperative that all agency rules remain subject to the full spectrum of congressional oversight afforded by law.”

Senators Cindy Hyde-Smith (R-MS), Rick Scott (R-FL), James Lankford (R-OK), and Mike Braun (R-IN), and 15 other members of Congress also signed the letter.