Supreme Court Justice Samuel Alito Puts Hold on FDA Approval of Abortion Pill Mifepristone: What It Means for Women's Reproductive Rights

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Key Highlights :

1. The Food and Drug Administration's approval of the abortion pill mifepristone is being challenged by anti-abortion rights advocates.
2. The challenge was brought by a conservative legal organization on behalf of the physicians and medical associations in .
3. Lawyers for the challengers argued the FDA erred in determining mifepristone's safety and effectiveness, and claimed the agency exceeded its regulatory authority in approving the drug more than 20 years ago.
4. The FDA has stressed that serious adverse events are exceedingly rare when mifepristone is used as the agency directs and noted that more than 5 million women have taken the medication since 2000.
5. The case is the most significant one involving abortion rights to land before the Supreme Court since it ended the constitutional right to abortion by last year.


Supreme Court Justice Samuel Alito granted the Justice Department's request to put on hold a lower court's decision involving the FDA's approval of the abortion pill mifepristone, preserving access to the drug for now. Limits on how late into a pregnancy the drug can be taken, who can prescribe it and how it can be dispensed were set to take effect Saturday at 1 a.m. Alito's hold will stay in place until 11:59 p.m. Wednesday. The Biden administration and the drug's maker, Danco Laboratories, asked the Supreme Court to intervene and block an April 7 order from a federal district judge that halted the FDA's 2000 approval of mifepristone and subsequent actions taken by the agency that made it easier to access.

This article will discuss the conflicting court orders, the FDA's stance on the drug's safety and effectiveness, and the impact of the decision on women's reproductive rights. The challenge to mifepristone's FDA approval is the latest effort from anti-abortion rights advocates to curtail abortion access. Medication abortions accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention. With access to mifepristone at risk, Democratic-led states have moved to beef up their supplies of the drug and misoprostol, which can be taken on its own, to ensure that women have access to safe and effective reproductive care.



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