Mifepristone REMS For Pharmacies Contains Some Unusual Provisions, Continues Debate Over Access
After FDA clears modified REMS, certified retail pharmacists are permitted to dispense the abortion medication. Some advocates argue program is unnecessary, while others want a broader federal effort to expand access. Walgreens intends to become a certified pharmacy.
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US CBER director Peter Marks suggests CDER could join its real-time communications pilot program, CDER's Jacqueline Corrigan-Curay says the use of decentralized trials has declined since the pandemic eased, and the GAO concludes that revisions to the mifepristone REMS do not require congressional review.
West Virginia judge finds GenBioPro has standing to sue state and that Comstock Act does not prohibit mailing of medication abortion drugs. Ruling deepens conflict between courts as Fifth Circuit hears appeal of Texas district court order staying approval of mifepristone.
Agency appeals Texas federal court decision staying its approval of the medication abortion pill. It is unclear how the ruling would be implemented if it stands, and what the impact might be from an opposing same-day order from another court for FDA to keep mifepristone available. Texas ruling could have significant consequences for industry, former FDA attorney says.