Supreme Court Could Curtail Mifepristone Access, Lay Out ‘Road Map’ To Challenge FDA Approvals

Court decision on whether an anti-abortion group has standing to challenge FDA actions could dispose of case or open door to similar suits. Ruling will determine if pre-2016 REMS restrictions are reinstated.

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US Supreme Court to decide whether FDA should not have eased restrictions on access to mifepristone • Source: Brenda Sandburg

The US Supreme Court’s ruling in the battle over access to the abortion pill mifepristone could determine whether the tighter pre-2016 restrictions on its use will go back into effect. But more broadly, the case could impact the US Food and Drug Administration’s scientific decisions about other drugs.

Key Takeaways

  • Supreme Court almost certainly won’t take the abortion pill off the market, but could essentially limit its availability to patients able to visit a doctor multiple times.

FDA and Danco Laboratories, manufacturer of Mifeprex (brand name mifepristone), are hoping the Supreme Court will overturn an appeals court...

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