Yahoo Finance Biden administration asks Supreme Court to restore status quo access to abortion drug
The US Justice Department has asked the Supreme Court to intervene in a legal fight over the Food and Drug Administration's approval of abortion medication.
On Friday, the Biden administration filed an application to pause a Texas federal district judge's April 7 order that temporarily suspended the FDA’s approval of mifepristone, one of the medications used in a two-drug regimen to end early pregnancy.
"This application concerns unprecedented lower court orders countermanding FDA's scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone," administration officials wrote in a request to keep mifepristone fully accessible and immediately reinstate FDA regulations that have governed access to the drug since 2016.
"If allowed to take effect, the lower courts' orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority."
The administration also asked for the court to do away with a subsequent order issued by the 5th Circuit Court of Appeals.
The dispute — one of two similar cases playing out in separate jurisdictions — led the appellate court in New Orleans to restore access to mifepristone according to pre-2016 FDA conditions which prohibited mail order prescriptions and use beyond approximately seven weeks of pregnancy. These rules also required patients to make three in-person doctor visits.
In the United States, two companies are FDA-approved to produce and sell mifepristone, Mifeprex brand manufacturer Danco Laboratories and generic manufacturer GenBioPro.
Mifepristone is the first of two separate drugs taken to terminate pregnancy in a medical abortion. Misoprostol, which is also used to treat ulcers and other ailments, is used in the second step of the two-pill regime.
In an email to Yahoo Finance following the appellate court's order, Danco marketing and public affairs director Abby Long said, "All changes that have been made to the Mifeprex label are supported by safety and efficacy data. FDA has been empowered by Congress to make decisions about what drugs are safe and effective and how they should be available to patients. Danco remains unchanged in its commitment to do all that we can to support and protect the availability of and access to Mifeprex for healthcare providers and all people in the United States."
In the Texas district court case underlying the 5th Circuit's emergency stay, US District Judge Matthew Kacsmaryk — a Trump appointee serving in the Northern District of Texas — suggested in an order to pause access to mifepristone that the FDA had obscured risks associated with the drug's use.
According to the FDA, mifepristone, which has been FDA-approved for 23 years and prescribed 5.6 million times since 2000, is associated with 28 patient deaths.
The drug is now used for a majority of abortions in the US and nearly all medical abortions. Since the Supreme Court overturned the Constitutional right to abortion last year the procedure has been fully banned in 13 states and banned after a certain duration of pregnancy in 5 US states.
The administration's request to stay the lower court orders was submitted to Justice Samuel Alito, who is assigned to handle emergency applications arising out of the 5th Circuit. Justice Alito can choose to issue a decision independently, or open the request to the court's full panel of justices to render a decision.
Alexis Keenan is a legal reporter for Yahoo Finance. Follow Alexis on Twitter @alexiskweed.
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