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1 1 (March 9, 2022)

handle is hein.crs/govefjp0001 and id is 1 raw text is: Congressional ______ *.Research Service Medication Abortion: A Changing Legal Landscape March 9, 2022 As the Supreme Court considers the constitutionality of abortion prohibitions before fetal viability in Dobbs v. Jackson Women 's Health Organization, there have been recent legal developments related to medication abortion, a pregnancy termination method involving the use of prescription drugs, rather than surgery. Recent attention has centered on the availability of these drugs through telehealth, particularly for pregnant individuals residing in areas with few or no abortion providers. Historically, the Food and Drug Administration (FDA) imposed distribution restrictions on mifepristone (brand name Mifeprex), requiring the drug to be dispensed in specified types of in-person health care settings. In December 2021, however, FDA announced it would lift the in-person dispensing requirements, allowing mifepristone to be prescribed via telehealth and sent to patients through the mail under certain conditions. Several states have taken steps to regulate access to medication abortion, leading to questions about the interplay between state and federal law. This Legal Sidebar explores federal regulation of medication abortion drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act), state efforts to regulate access to medication abortion, and considerations for Congress. FDA Regulation of Medication Abortion According to recent data published by the Centers for Disease Control, medication abortions represented approximately 42% of all U.S. abortions by 2019. The medication abortion regimen involves use of the prescription drug mifepristone, followed by a second drug, misoprostol, to terminate an early pregnancy. Similar to other prescription drugs available on the market, FDA evaluated and approved the medication abortion drugs pursuant to the agency's authority under the FD&C Act. As a condition of mifepristone's approval, FDA requires compliance with a risk evaluation mitigation strategy, or REMS. In general, a REMS is an FDA-imposed drug safety plan designed to ensure that the benefits of a drug outweigh its risks. While modified over time, the 2019 version of the mifepristone REMS requires health care professionals who prescribe the drug to be certified and meet particular qualifications (e.g., the ability to accurately assess the duration of a pregnancy), and ensure that patients receive and sign a patient agreement form relating to mifepristone use. Additionally, the REMS specifies that mifepristone could only be dispensed in certain clinics, medical offices, and hospitals, or under the supervision of a certified prescriber (although a patient could take the drug in a different location, including the patient's home). These in-person dispensing requirements sparked extensive debate and ongoing litigation. While FDA Congressional Research Service https://crsreports.congress.gov LSB10706 CRS Legal Sidebar Prepared for Members and Committees of Congress

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