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1 1 (October 5, 2022)

handle is hein.crs/govejch0001 and id is 1 raw text is: Congressional_______ S*Research Service Medication Abortion: A Changing Legal Landscape Updated October 5, 2022 Following the Supreme Court's decision in Dobbs v. Jackson Women 's Health Organization, questions have been raised about continued access to medication abortion, a pregnancy termination method involving the use of prescription drugs. Recent attention has centered on the availability of these drugs, as their availability may allow those residing in areas with few or no abortion providers to access an elective abortion. The Food and Drug Administration (FDA) regulates the distribution of mifepristone (sold under the brand name Mifeprex) pursuant to its authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the agency's current policies may permit the drug to be dispensed to patients without an in-person visit to a health care provider. At the same time, state legislatures have taken steps to restrict access to medication abortion, including bans on medication abortion drugs under particular circumstances. Prior to Dobbs, such restrictions may have been subject to legal challenge based on the Court's abortion-related decisions in Roe v. Wade, Planned Parenthood of Southeastern Pennsylvania v. Casey, and other cases that recognized a woman's constitutional right to terminate a pregnancy. Now that Roe and Casey have been overruled, a state's ability to restrict or prohibit access to these drugs may depend on the interplay between state and federal law. This Legal Sidebar explores federal regulations of medication abortion drugs under the FD&C Act, state efforts to regulate access to medication abortion, issues related to federal preemption of state law, and related legislation in the 117th Congress. FDA Regulation of Medication Abortion According to recent data published by the Centers for Disease Control and Prevention, medication abortions represented approximately 42% of all U.S. abortions by 2019. The medication abortion regimen involves using 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 in accordance with requirements of 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 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 form relating to mifepristone use. Congressional Research Service https://crsreports.congress.gov LSB10706 CRS Legal Sidebar Prepared for Members and Committees of Congress

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