washington — The Justice Department on Monday asked a Washington state judge to clarify his obligations under an order that the Food and Drug Administration (FDA) maintain availability of the drug abortion pill in more than a dozen states as it conflicts with a separate decision of a federal judge in Texas that stopped the agency’s approval of the same drug.
U.S. District Judge Thomas Rice of the Federal District Court in Spokane on Friday issued an injunction preventing the FDA from “changing the status quo and rights regarding the availability of mifepristone,” one of two drugs used in medical abortions be used.
Rice’s order applies only to the 16 states and the District of Columbia that sued the Biden administration in February to protect access to mifepristone.
However, Rice’s decision followed a ruling by a federal judge in Amarillo, Texas, in a separate case involving mifepristone, that blocked FDA approval of the drug. Unlike Rice’s decision, US District Judge Matthew Kacsmaryk’s ruling applies nationwide.
Kacsmaryk deferred his decision for seven days to allow the Biden administration to appeal to the U.S. 5th Circuit Court of Appeals, which it did on Friday. But in its most recent filing with Rice, the Justice Department asked him to continue his obligations under the restraining order “in the event that the [Texas] The order is effective and remains the approval of mifepristone.”
“The outcome of this order appears to be in material conflict with this court’s order prohibiting the FDA from altering the status quo and rights regarding the availability of mifepristone in the plaintiff states,” the Biden administration said. “The court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart.”
Rice was appointed by former President Barack Obama, and Kacsmaryk was nominated for the Federal Bank by former President Donald Trump.
The competing orders from Texas and Washington created a whiplash over access to mifepristone and added further uncertainty to a legal landscape upended by the Last year’s Supreme Court decision in which Roe v. Wade was lifted.
The Texas case was brought up in November by an anti-abortion group and medical associations that challenged the FDA’s 2000 approval of mifepristone and asked the court to suspend or withdraw that approval.
While Kacsmaryk’s decision didn’t go that far, the White House and abortion rights advocates called the ruling “unprecedented” and warned it could affect the FDA’s ability to approve other drugs.
In the Washington case, 16 states and the District of Columbia sued the FDA, arguing that it singled out mifepristone because of a “unique set of limitations,” known as the risk assessment and mitigation strategy, that placed burdens on a drug being ingested It has been on the market for more than two decades and has “extremely rare” adverse events.
States claimed the restrictions made dispensing mifepristone more difficult for them and their healthcare providers, and more difficult for patients to access. They asked the court to maintain the status quo by preventing the FDA from taking mifepristone off the market, and Rice granted the states’ motion.
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 removing the requirement for the pills to be delivered in person in 2021, making the drug prescribed by a could be sent to service providers for telemedical appointments and by post.
However, the FDA still maintains additional requirements for mifepristone, including that the drug must be prescribed by a healthcare provider who meets certain qualifications and is certified under the Mifepristone REMS program, which requires providers to fill out a prescriber agreement form. The abortion pill can also only be dispensed by or under the supervision of a certified prescribing physician, which requires pharmacies to fill out a pharmacy agreement form. The FDA also requires a patient to read and sign a patient agreement form.
Medical abortions have become increasingly 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 states that since FDA approval in 2000, medical abortions have been used by over 3 million women in the United States and that they are “safe and effective.”
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