Justice Department Seeks Clarification From Federal Court Over Competing Abortion Pill Rulings

Washington- The Justice Department on Monday asked a federal judge in Washington state to clarify his obligations under an order that the Food and Drug Administration (FDA) maintains the availability of the abortion pill in more than a dozen states because it contradicts a separate decision by a Texas federal judge which halted the agency’s approval of the same drug.

U.S. District Judge Thomas Rice of the Federal District Court in Spokane issued a preliminary injunction on Friday that prevents the FDA from “changing the status quo and rights with respect to the availability of mifepristone,” one of the two drugs used in medical abortions.

Rice’s order only applies to the 16 states and the District of Columbia that sued the Biden administration in February in an effort to protect access to mifepristone.

But Rice’s decision follows a ruling by a federal judge in Amarillo, Texas, in a separate case involving mifepristone, which blocked the drug’s FDA approval. Unlike Rice’s ruling, U.S. District Judge Matthew Kacsmaryk’s decision applies nationwide.

Kacsmaryk suspended her decision for seven days to allow the Biden administration to appeal to the US Court of Appeals for the 5th Circuit, which it did on Friday. But in its latest petition to Rice, the Justice Department asked him to clarify his obligations under the preliminary injunction “in the event that the [Texas] the order takes effect and suspends the approval of mifepristone.

“The outcome of this order appears to be in significant tension with this court’s order prohibiting the FDA from ‘altering the status quo and rights with respect to the availability of mifepristone’ in the requesting states,” the author wrote. Biden administration. “The court did not address the interaction between the two orders, likely because they were issued less than 20 minutes apart.”

Rice was nominated by former President Barack Obama and Kacsmaryk was appointed to the federal bench by former President Donald Trump.

Competing orders from Texas and Washington have created a sense of whiplash over access to mifepristone and added further uncertainty in a legal landscape disrupted by the Last year’s Supreme Court decision overturning Roe v. wade.

The Texas case was brought in November by a group of doctors and anti-abortion medical associations who challenged the FDA’s 2000 approval of mifepristone and asked the court to suspend or revoke that approval.

Although Kacsmaryk’s decision didn’t go that far, the White House and abortion rights advocates called the decision “unprecedented” and warned it could impact the FDA’s ability to approve other drugs.

In the Washington case, 16 states and the District of Columbia sued the FDA and argued that it singled out mifepristone for a “unique set of restrictions,” known as the Evaluation and Mitigation Strategy. risk, which imposed burdens on a drug that has been on the market for more than two decades and has “extremely rare” adverse events.

The states claimed the restrictions made mifepristone harder for them and their healthcare providers to distribute, and harder for patients to access. They asked the court to preserve the status quo by preventing the FDA from removing mifepristone from the market, and Rice granted the states’ request.

The FDA approved mifepristone more than 20 years ago, and the drug is taken with a second drug, misoprostol, to terminate a pregnancy up to 10 weeks gestation. Since then, the agency has made several changes to the rules surrounding the abortion pill, including approving a generic version of mifepristone in 2019 and lifting the requirement that pills must be dispensed in person in 2021, which allowed the drug to be prescribed by a doctor. provider during telemedicine appointments and sent by mail.

But the FDA still maintains an additional set of requirements for mifepristone, including that the drug must be prescribed by a healthcare provider who meets certain qualifications and is certified under the REMS mifepristone program, which requires providers complete a prescriber consent form. The abortion pill can also only be dispensed by or under the supervision of a certified prescriber, which requires pharmacies to complete a pharmacy agreement form. The FDA also requires a patient to review and sign a patient consent form.

Medical abortions have become more common over the years, accounting for more than half of all abortions in the United States in 2020, according to the Centers for Disease Control and Prevention. The American College of Obstetricians and Gynecologists notes that medical abortion has been used by more than 3 million women in the United States since FDA approval in 2000, and states that it is “safe and effective”.

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