Federal judge strikes down FDA limits on abortion pill
A U.S. federal judge in Maryland ruled that the FDA's restrictions on the abortion medication mifepristone were unlawful, benefiting plaintiffs from three states. The decision blocks requirements for in-person dispensing and a reduced gestational age limit. This preserves broader access to the drug used in most medication abortions.
On October 8, 2024, U.S. District Judge Theodore D. Chuang issued a ruling in a lawsuit brought by New York, Connecticut, and Washington state against the Food and Drug Administration (FDA). The judge found that the FDA's 2019 and 2021 modifications to the prescribing information for mifepristone violated the Administrative Procedure Act by being arbitrary and capricious.
Mifepristone, approved by the FDA in 2000, is the first drug in a two-step regimen for medication abortion, which accounts for more than 60% of abortions in the United States. The 2016 FDA label allowed use up to 10 weeks of pregnancy with in-person administration. However, in 2019, the agency reduced the limit to seven weeks, and in 2021, it added requirements for in-person dispensing and follow-up visits, citing safety concerns amid increased demand.
Judge Chuang's 78-page opinion stated, 'The FDA failed to provide a reasoned explanation for its decisions,' particularly regarding the risk evaluation and mitigation strategy (REMS) changes. The ruling enjoins the FDA from enforcing these restrictions in the plaintiff states, maintaining access via telehealth and the original 10-week limit.
This decision comes amid ongoing legal battles over abortion access following the 2022 Supreme Court overturning of Roe v. Wade. The FDA had defended its actions as necessary to ensure safe use, but the court sided with the states' argument that the changes lacked sufficient evidence and hindered access without improving safety outcomes.
Advocates for reproductive rights hailed the ruling as a victory for patients. 'This protects essential healthcare in the face of political interference,' said a spokesperson for the plaintiffs. The FDA may appeal, potentially escalating the case to higher courts. The ruling does not affect nationwide access but sets a precedent for similar challenges.