Senator Mayer & 31 NYS Senate Democratic Colleagues Urge FDA to Improve Access to Safe Abortion Care

Remove Burdensome Regulations Surrounding the Prescription, Dispensing, and Pharmaceutical Distribution of Mifepristone

(Port Chester, NY) – In the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, New York State Senator Shelley B. Mayer and 31 of her New York State Senate Democratic colleagues sent a letter to Dr. Robert Califf, Commissioner of Food and Drugs at the U.S. Food and Drug Administration, urging him to remove burdensome regulations surrounding the prescription, dispensing, and pharmaceutical distribution of the abortion pill mifepristone, an essential option for those seeking abortions, through the removal of the Risk Evaluation and Mitigation Strategy (REMS) and Elements To Assure Safe Use (ETASU) requirements.

“In New York State, we have taken strong steps to ensure we remain one of only several safe haven states for women seeking an abortion. We are concerned that, notwithstanding the safety and efficacy of mifepristone for use in medical abortions, the FDA’s current limitations on prescribers and planned restrictions on pharmacies place unwarranted limits on who can prescribe, dispense and obtain mifepristone,” said Senator Shelley B. Mayer. “These limits are not acceptable given the safety and efficacy of this medication, the unique applicability of the medication for medical abortion, and the urgent need for action. As some of us have already requested prior to the Dobbs decision, we urge you to reexamine your current rules and move to immediately expand who may prescribe and dispense this medication.”

Earlier this year, Senator Mayer co-sponsored legislation to protect patients traveling to New York for healthcare from states that have taken away their reproductive rights as well as providers, which was subsequently passed by the legislature under the leadership of Senate Majority Leader Andrea Stewart-Cousins and Assembly Speaker Carl Heastie, and signed into law by Governor Kathy Hochul on June 13. Additionally, the legislature began the process of codifying reproductive rights in the New York State Constitution during the Extraordinary Session.