Justice Department seeks clarification from federal court on competing abortion pill rulings

Washington — The Justice Department asked a federal judge in Washington state on Monday to clarify its obligations under an order that the Food and Drug Administration (FDA) maintains the availability of the abortion pill in more than a dozen states, as it is at odds with a separate decision from a federal judge in Texas that 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 Friday that blocked the FDA from “altering the status quo and rights as it relates to the availability of mifepristone,” one of two drugs used in medication abortions.

Rice’s order applies only 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 came on the heels of a ruling from a federal judge in Amarillo, Texas, in a separate case involving mifepristone, which blocked the FDA’s approval of the drug. Unlike Rice’s decision, the ruling from U.S. District Judge Matthew Kacsmaryk applies nationwide. 

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

“The result of that order appears to be in significant tension with this court’s order prohibiting FDA from ‘altering the status quo and rights as it relates to the availability of mifepristone’ in plaintiff states,” the Biden administration wote. “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 to the federal bench by former President Donald Trump.

The competing orders from Texas and Washington created a sense of whiplash regarding access to mifepristone and injected further uncertainty into a legal landscape upended by the Supreme Court’s decision last year overturning Roe v. Wade.

The case from Texas was brought in November by a group of anti-abortion rights physicians and medical associations who challenged the FDA’s approval of mifepristone in 2000 and requested the court suspend or withdraw that approval.

While Kacsmaryk’s decision did not go that far, the White House and pro-abortion rights advocates called the ruling “unprecedented” and warned it could impact the FDA’s ability to approve other medications. 

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

The states claimed the restrictions made mifepristone more difficult for them and their health care providers to dispense, and harder for patients to access. They asked the court to preserve the status quo by blocking 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 together with a second medicine, misoprostol, to terminate a pregnancy through 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 a requirement that the pills be dispensed in-person in 2021, which allowed the drug to be prescribed by a 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 health care provider that meets certain qualifications and is certified under the Mifepristone REMS Program, which requires providers to complete a prescriber agreement 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 mandates that a patient must review and sign a Patient Agreement Form.

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

Source link

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    Skip to content