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1 1 (July 8, 2022)

handle is hein.crs/goveiep0001 and id is 1 raw text is: \Congressional_______ * Research Service Medication Abortion: A Changing Legal Landscape Updated July 8, 2022 Following the Supreme Court's recent 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 regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Recent attention has centered on the availability of these drugs, as the drugs' availability may allow those residing in areas with few or no abortion providers to have access to an elective abortion. The Food and Drug Administration (FDA) regulates the distribution of mifepristone (sold under the brand name Mifeprex), and the agency's current policies allow the drug to be prescribed via telehealth and sent to patients through the mail under specified conditions. At the same time, state legislatures have taken steps to regulate access to medication abortion, including, since the Court's decision in Dobbs, proposing specific 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 decisions in Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey, as well as other cases that recognized a woman's constitutional right to terminate a pregnancy. Now that the Court's majority opinion in Dobbs has overruled Roe and Casey, a state's ability to restrict or prohibit access to these drugs may solely 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 and issues regarding federal preemption, and considerations for 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 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 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, Congressional Research Service https://crsreports.congress.gov LSB10706 CRS Legal Sidebar Prepared for Members and Committees of Congress

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