New court-imposed restrictions on the abortion pill mifepristone could cut off access to the drug entirely for months, the Biden administration and the drug's distributor, Danco Laboratories, said in petitions asking the U.S. Supreme Court to lift the curbs.
Marketing the drugs under the conditions imposed by the 5th U.S. Circuit Court of Appeals on Wednesday will require a new approval from the U.S. Food and Drug Administration and new labeling, they said.
Danco, whose sole product is the abortion pill, said that if the Supreme Court does not act, it may have to halt its operations.
The FDA declined to comment. Danco could not immediately be reached for comment.
Following the 5th Circuit's ruling, mifepristone must be prescribed and dispensed by a doctor in person over multiple visits and can only be used only within the first seven weeks of pregnancy, restoring restrictions that the FDA had lifted since 2016.
However, both the government and Danco said in their filings that the company cannot immediately revert to the 2016 conditions. Instead, they said, Danco must obtain approval for new labels and safety procedures, and doctors must be certified to prescribe mifepristone under the new limits.
They also noted that a conflicting ruling from a federal judge in Spokane, Washington forbids the FDA from tightening restrictions on the drug in 17 states, which could prevent it from granting the necessary approvals.
Legal experts have said that the FDA could choose not to enforce the new court-imposed restrictions, particularly in light of the conflicting orders, though it is not clear whether the agency will take that route.
The 5th Circuit's order also suspended approval for the only generic version of mifepristone, which is sold by GenBioPro Inc. GenBioPro on Thursday told pharmacies that it sells to that it would be in touch with them once it had more information about the orders.
Some Democratic-led states have said that they have taken steps to stockpile mifepristone in case it becomes unavailable.
(Reporting By Brendan Pierson in New York, editing by Alexia Garamfalvi and Peter Henderson)
