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1 1 (February 14, 2023)

handle is hein.crs/govekou0001 and id is 1 raw text is: Congressional_______ ~ Research Service8 Medication Abortion: New Litigation May Affect Access February 14, 2023 After the Supreme Court's decision in Dobbs v. Jackson Women 's Health Organization, there has been increasing focus on federal and state regulation of medication abortion-a pregnancy termination method involving the use of prescription drugs. Recent attention has centered on how medication abortion drugs may provide broader access to elective abortion, particularly for those residing in areas with few or no abortion providers. The scope of federal and state authority to regulate medication abortion is now the subject of litigation that may affect access to these products. This Legal Sidebar discusses federal and state regulation of medication abortion drugs, recently filed lawsuits concerning medication abortion, and selected legal considerations for Congress. Background on FDA and State Regulation of Medication Abortion According to recent data, medication abortions represent roughly half of all U.S. abortions. The medication abortion regimen typically involves using the prescription drug mifepristone (the only drug approved by the Food and Drug Administration (FDA) as an abortifacient), followed by a second drug, misoprostol, to terminate an early pregnancy. Like other prescription drugs available on the market, FDA evaluated and approved the medication abortion drugs pursuant to requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under current law, to market a new brand-name drug, a manufacturer must file a new drug application with FDA, which must include full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use. FDA may approve an application if the sponsor of the application (e.g., a drug manufacturer or marketer) demonstrates, among other things, that the drug is safe and effective under the conditions prescribed, recommended, or suggested in the product's labeling. As a condition of mifepristone's approval, FDA requires compliance with distribution controls pursuant to a risk evaluation and mitigation strategy, or REMS. In general, a REMS is an FDA-imposed drug safety plan designed to ensure that the benefits of a drug with serious potential safety concerns outweigh its risks. While the mifepristone REMS has been modified over time, the current version requires health care professionals who prescribe the drug to be certified; meet particular qualifications (e.g., the ability to assess the duration of a pregnancy accurately); and ensure that patients receive and sign a patient agreement fonn relating to mifepristone use. Earlier REMS versions specified that mifepristone had to be Congressional Research Service https://crsreports.congress.gov LSB10919 CRS Legal Sidebar Prepared for Members and Committees of Congress

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