Mifepristone, also often called RU-486, is a drugs typically used together with misoprostol to bring a few medical abortion while pregnant and manage early miscarriage.
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Drug company Danco Laboratories on Friday asked the Supreme Court to review the case difficult the legality of the abortion pill mifepristone.
Danco’s request is available in response to a ruling by the U.S. Court of Appeals for the Fifth Circuit that might impose major restrictions on how the medication is used and distributed to patients.
Danco, which distributes the abortion pill, wants the Supreme Court to reverse the lower court ruling. The drug company said the case is of “indisputable importance” to women’s health in addition to the pharmaceutical industry.
“For the ladies and teenage girls, health care providers, and States that rely upon FDA’s actions to make sure secure and effective reproductive health care is obtainable, this case matters tremendously,” Danco’s attorneys wrote of their filing.
“And for the pharmaceutical and biotechnology industry, permitting judicial second-guessing of FDA’s scientific evaluations of knowledge could have a wildly destabilizing effect,” the attorneys wrote.
Danco’s request for the Supreme Court to take up the case comes nearly 15 months after the court’s conservative majority overturned Roe v. Wade, the landmark 1973 decision that protected abortion as a constitutional right. Greater than a dozen states have banned abortion within the wake of that ruling.
The Supreme Court’s latest term starts next month. 4 justices must comply with take up the abortion pill case. The U.S. Department of Justice can also be expected to ask the high court to review the case.
Download Danco Laboratories’ filing here.
The appeals court ruling is on hold until the Supreme Court comes to a decision concerning the case. The high court, in April, pressed pause on lower court decisions as litigation concerning the pill proceeds in response to a request from the Biden administration.
A 3-judge panel on the Fifth Circuit ruled that decisions the U.S. Food and Drug Administration took in recent times to make mifepristone more accessible to women failed to handle safety concerns.
Should the Supreme Court take the case and uphold the appeals court decision, mifepristone will remain available on the market within the U.S., but patients will face more barriers to accessing the medication.
If the high court declines to take the case, the appeals court restrictions will go into effect.
Mifepristone, used together with one other drug called misoprostol, is probably the most common method to terminate a pregnancy within the U.S.
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The appeals court order would end mail delivery of mifepristone and prescriptions via telemedicine appointments. Women would must see a physician in person to get a prescription and go to a few follow-up visits as they take the course of medication.
The ruling also shortens the time when women can take mifepristone to seven weeks into their pregnancy, down from 10 weeks currently.
The litigation against mifepristone began last November when a gaggle of physicians who oppose abortion called the Alliance for Hippocratic Medicine sued to overturn the FDA’s original approval of the pill, which dates back greater than 20 years.
U.S. Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a sweeping order in April that suspended the FDA approval of mifepristone.
The appeals court dialed back Kacsmaryk’s order and kept the unique FDA approval in place in addition to the agency’s authorization of a generic type of the pill.
