A federal judge in Texas will hear arguments Wednesday in a closely watched dispute that could halt distribution of a key drug used for medication abortion and disrupt access nationwide, even in states where reproductive rights are protected.
the challengers' request for the court to withdraw approval of mifepristone is"extraordinary and unprecedented." Administration lawyers said they have been unable to find any case where a court has"second-guessed FDA's safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market — much less an example that includes a two-decade delay.
The Biden administration argued that serious adverse events associated with mifepristone are rare and said the claims raised by the medical associations are speculative. Patients, they said, would be harmed by a court order rescinding mifepristone's approval. The Justice Department further warned that halting access to mifepristone would threaten the capacity of state healthcare systems, as it would lead more patients to seek surgical abortions at clinics already under stress from patients traveling from states with restrictive abortion laws to seek care.
A coalition of 22 red states that have tightened abortion restrictions after the Supreme Court reversed Roe are siding with the anti-abortion rights associations and accused the FDA of contravening federal law.
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