Supreme Court’s Stay Of Mifepristone Ruling Gives FDA Respite For Next Round
Medication abortion pill can remain on the market under current conditions until appeal on the merits of the preliminary injunction is decided. Justice Alito dissents, noting that FDA could exercise its enforcement discretion to prevent harm to mifepristone manufacturer Danco.
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Students for Life of America requests that FDA revoke approval of mifepristone and REMS changes, claiming the agency failed to determine the medication abortion drug would not pollute waterways. The group’s fourth citizen petition follows similar claim that the agency failed to comply with the Endangered Species Act.
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.
Commissioner also talks drug shortages, difficulty getting key agency and industry priorities done in new pandemic legislation, and how legal challenges to FDA authority could impact pharma companies desire to develop new medicines.