Supreme Court Revisits Abortion Pill Access and FDA’s Authority in Landmark Case

December 13, 2023

The Supreme Court has agreed to review the accessibility of mifepristone, a commonly used abortion pill, marking its first significant abortion case since the overturning of Roe v. Wade. The decision to hear this case could significantly impact the Food and Drug Administration’s (FDA) regulatory authority.

Since Roe v. Wade was overturned, allowing states to set their abortion laws, 13 states have banned abortion, and seven others have imposed severe restrictions. The Supreme Court’s upcoming decision will focus on state-level restrictions concerning mifepristone, which the FDA approved over two decades ago for abortions up to 10 weeks. Medication abortions, which primarily involve mifepristone, account for about half of all abortions annually.

The case arises amidst conflicting judicial decisions. A Texas judge ruled that the FDA had ignored safety concerns due to political pressure when approving mifepristone. In contrast, a Washington state judge directed the FDA to maintain its approval, citing its proven safety record.

After temporarily staying the Texas decision, the Biden administration has appealed the Texas ruling, and the Supreme Court has now agreed to review the case. The Alliance for Hippocratic Medicine and Danco Laboratories initiated the lawsuit; the manufacturer of Mifeprex (a branded version of mifepristone) is a defendant.

This case arrives at a time when the Supreme Court’s stance on abortion is critical, especially after its 5-4 ruling in June 2022 to overturn Roe v. Wade. This previous ruling has opened discussions about the potential to review other rights established in past cases.

GenBioPro, which produces a generic form of mifepristone, asserts that the drug remains lawfully available but expresses concern over the courts being used to challenge scientific evidence and access to medication.

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[Source: STAT, December 13th, 2023]

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