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Danco Laboratories asks the Supreme Court to decide the abortion pill case

US President Joe Biden delivers a speech on abortion rights in a speech hosted by the Democratic National Committee (DNC) at the Howard Theater in Washington, October 18, 2022.

Leah Millis | Reuters

Pharmaceutical company Danco Laboratories has asked the Supreme Court to reconsider the case challenging the legality of mifepristone, an abortion pill.

Danco’s request follows a ruling by the US Court of Appeals for the 5th Circuit that would place significant restrictions on how the drug is used and dispensed to patients.

The pharmaceutical company, which distributes the abortion pill, asked the Supreme Court to overturn the lower court’s decision, saying the case is of “unquestionable importance” to women’s health as well as to the pharmaceutical industry.

“For the women and adolescent girls, health care providers, and states who depend on the actions of the FDA to ensure the availability of safe and effective reproductive health care, this case is extremely important,” Danco’s attorneys wrote. in their file.

“And for the pharmaceutical and biotech industry, allowing judicial challenge to the scientific assessments of the data by the FDA will be extremely destabilizing,” the attorneys wrote.

The decision of the appeals court is suspended until the Supreme Court rules on the case. In April, the High Court imposed a pause on lower court rulings as litigation over the pill continues in response to a request from the Biden administration.

A panel of three 5th Circuit judges ruled that decisions made by the Food and Drug Administration in recent years to make mifepristone more available to women fail to address safety concerns.

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If the Supreme Court takes up the case and upholds the appeals court’s decision, mifepristone will remain on the market in the United States, but patients will face more barriers to accessing the drug.

If the High Court declines to take up the case, the Court of Appeal restrictions will come into effect.

Mifepristone, used in combination with another drug called misoprostol, is the most common method of terminating a pregnancy in the United States.

The appeals court order would end the mail delivery of mifepristone and prescriptions through telemedicine appointments. Women should see a doctor in person to get a prescription and go for three follow-up visits while on their treatment.

The decision also reduces the time frame in which women can take mifepristone to seven weeks after the start of their pregnancy, from the current 10 weeks.

The mifepristone litigation began last November when a group of anti-abortion doctors called the Alliance for Hippocratic Medicine filed a lawsuit to overturn the pill’s original FDA approval, which dates back to over 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 suspending FDA approval of mifepristone.

The appeals court overturned Kacsmaryk’s order and upheld the original FDA approval as well as the agency’s clearance for a generic form of the pill.

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