Maryland Attorney General Anthony G. Brown is part of a coalition of 17 states and the District of Columbia that has formally petitioned the U.S. Food and Drug Administration (FDA) to remove what they describe as burdensome restrictions on mifepristone. Mifepristone is one of two medications used in medication abortions. The filing emphasizes the established safety of medication abortion and highlights the obstacles created by the FDA’s current regulations on mifepristone access, particularly for individuals in rural and medically underserved areas.
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The petition supplements a citizen petition previously filed with the FDA by California, Massachusetts, New Jersey, and New York. The coalition’s filing presents extensive evidence supporting the safety and efficacy of mifepristone, a drug that has been FDA-approved since 2000 for use in conjunction with misoprostol to end early pregnancies. Scientific studies and the experience of over 7.5 million women in the U.S. who have safely used mifepristone for abortion care or miscarriage management underscore its safety profile. Despite this record, the FDA has maintained restrictions that the petition argues are not justified by the drug’s history.
These restrictions, which are noted as being unique among FDA-regulated drugs, include requirements for healthcare providers to become registered prescribers, special certification for pharmacies to dispense the medication, and mandatory patient forms acknowledging voluntary pregnancy termination. Such measures, according to the petition, hinder medical professionals who are already trained to prescribe mifepristone and create unnecessary hurdles for patients seeking access. Attorney General Brown and the coalition are seeking the elimination of these restrictions. Alternatively, they have requested that the FDA cease enforcement of these requirements within their respective states, arguing that their existing regulatory frameworks adequately ensure patient safety.
The states joining Maryland in this petition are Arizona, Colorado, Connecticut, Delaware, Hawai‘i, Illinois, Maine, Michigan, Minnesota, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Washington, and Pennsylvania, with Governor Josh Shapiro representing the Commonwealth of Pennsylvania. The filing comes in the context of a broader review of mifepristone, with U.S. Health and Human Services Secretary Robert F. Kennedy Jr. having indicated a comprehensive review of the drug in May.
Article by Mel Anara, based upon information from the Maryland Attorney General’s Office.
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