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FDA’s Authority Looks Safe From Judicial Interference Following Supreme Court Abortion Pill Arguments

Executive Summary

The agency's and the pharma industry’s worst fears – that a potential ruling in the mifepristone case might usurp the FDA’s scientific authority and throw the stability of the US drug approval process into question – seem unlikely to materialize as the majority of the Supreme Court justices signal the Alliance for Hippocratic Medicine lacks standing to sue.

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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.

Mifepristone Ruling Casts ‘Shadow Of Uncertainty’ Over Every FDA Approval, Biopharma Industry Tells Supreme Court

As the new Supreme Court term begins, PhRMA and a host of biopharma CEOs and investors implore justices to take up mifepristone case to prevent chaos for drug development. High court will also consider a lawsuit that would reduce deference to federal rulemaking and it may consider another that would increase corporate liability under the Anti-Terrorism Act.

Breaking Down The Arguments In The Mifepristone Case

Chart encapsulates the fundamental questions in Alliance for Hippocratic Medicine v. FDA and the arguments of both parties on standing to sue, the agency’s approval standards, REMS changes, and the Comstock Act of 1873.

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