Comment from The Catholic Medical Association
AnonymousOpposeAdvocacy
Summary: The Catholic Medical Association (CMA) opposes the petition to reduce or eliminate FDA safety regulations (REMS and EASU) for mifepristone. They argue that the petition relies on biased data that underestimates serious adverse effects and that removing these safeguards would exacerbate ethical issues, risks to minors, and potential for coercion in telemedicine chemical abortions.
Edit to Comment Tracking Number: me1-mz29-3zai. We are a Health Care Association. The Catholic Medical Association (CMA), the largest association of Catholic physicians and healthcare professionals in the United States, submits the attached comments in response to the above-referenced Citizen Petition. This petition seeks to reduce or eliminate the FDA’s current safety regulations on the chemical abortion drug mifepristone, specifically concerning the Risk Evaluation and Mitigation Strategy (REMS) and Elements to Assure Safe Use (EASU), including Prescriber, Patient, and Pharmacy Certification elements. The CMA strongly opposes the requested changes to mifepristone’s REMS and EASU oversight based on two primary concerns: 1. Reliance on Inadequate and Biased Data; 2. Ethical and Societal Consequences of Chemical Abortion.