Mifepristone, also known as RU-486, is a medication commonly used in combination with misoprostol to induce a medical abortion during pregnancy and manage early miscarriage.
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The pharmaceutical company, Danco Laboratories, has filed a request with the Supreme Court to review the case challenging the legality of the abortion pill mifepristone.
This request from Danco follows a ruling by the U.S. Court of Appeals for the 5th Circuit, which would impose significant restrictions on the usage and distribution of the medication to patients.
Danco, the distributor of the abortion pill, is urging the Supreme Court to reverse the decision made by the lower court, emphasizing the “indisputable importance” of the case to women’s health and the pharmaceutical industry.
In their official filing, Danco’s attorneys stated, “This case matters tremendously to the women, teenage girls, health care providers, and states that rely on FDA’s actions to ensure the availability of safe and effective reproductive health care. Additionally, it will have a wildly destabilizing effect on the pharmaceutical and biotechnology industry by permitting judicial second-guessing of FDA’s scientific evaluations of data.”
The Supreme Court’s next term is set to begin next month, and at least four justices must agree to take up the case.
The appeals court ruling is temporarily on hold while the Supreme Court decides whether to hear the case. In April, the high court paused lower court decisions to allow for ongoing litigation regarding mifepristone at the request of the Biden administration.
A three-judge panel at the 5th Circuit declared that the recent decisions made by the Food and Drug Administration (FDA) to increase access to mifepristone for women did not adequately address safety concerns.
If the Supreme Court decides to take on the case and upholds the appeals court ruling, mifepristone will remain on the market in the United States, but patients will encounter more obstacles when seeking the medication.
If the Supreme Court declines to hear the case, the restrictions set by the appeals court will take effect.
Mifepristone, when used in combination with another drug called misoprostol, is the most commonly used method for terminating a pregnancy in the United States.
The appeals court order would eliminate mail delivery of mifepristone and prescriptions obtained through telemedicine appointments. Women would be required to visit a doctor in person to acquire a prescription and attend three follow-up visits while undergoing the medication regimen.
The ruling also shortens the timeframe for women to take mifepristone to seven weeks into their pregnancy, down from the current 10-week limit.
The litigation against mifepristone originated in November of last year when the Alliance for Hippocratic Medicine, a group of physicians opposing abortion, filed a lawsuit to overturn the FDA’s original approval of the pill, which dates back over 20 years.
In April, U.S. Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a broad order that suspended the FDA’s approval of mifepristone.
The appeals court scaled back Judge Kacsmaryk’s order and maintained the original FDA approval of the pill, as well as the agency’s authorization of a generic version.
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