New Attack Against FDA’s Mifepristone Approval Targets Potential Water Contamination
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.
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There are growing demands from government officials, investors and employees for the pharmaceutical industry to reduce emissions and waste, and – most of all – make environmental sustainability a core part of its business.
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.
Attorneys discuss host of questions the agency faces in the wake of the Dobbs decision, including whether to take enforcement action against mifepristone REMS violations, whether to change restrictions on its use, and how to deal with challenges to its drug approval authority.