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US Supreme The court on Friday stayed a lower court’s order to ban the abortion pill mifepristone. The act means the drug remains available and legal until the case goes through an appeals process, which could take months.
The final decision of the court may be the highest result since the abolition of reproductive rights Roe v. Wade In June 2022
Mifepristone has been available in the United States since 2000, when the US Food and Drug Administration approved its use. It is the first dose of the two-drug series used in medical abortions, which now account for more than half of all abortions in the country. Medication abortion is already restricted in 15 states.
But on April 7, Judge Matthew Kaczmaric of the Northern District of Texas ruled to revoke the drug’s license nationwide. In the case, the plaintiffs’ anti-abortion doctors argued that the drug was unsafe and FDA approval was invalid because pregnancy is not a disease. However, the drug has a decades-long safety record, and a comprehensive review by the National Academies of Sciences found it to have a very low rate of serious complications.
The following week, the Fifth Circuit Court of Appeals partially blocked Kaczmaric’s decision, allowing the pill to retain FDA approval but reversing changes the agency has made in recent years to expand its reach. Among them: pandemic provisions that made it easier to order mifepristone online and distribute it by mail, and a 2016 change that allowed the pill to be taken up to the 10th week of pregnancy.
The US Department of Justice, acting on behalf of the FDA and New York-based Danco Laboratories, which makes mifepristone, asked the judges to intervene. Last week, the Supreme Court issued two separate short-term jail terms while examining the case. The court had set a deadline of midnight Wednesday to decide whether the pill would face tougher laws while the appeal continues, but extended the deadline until today.
GenBioPro, the maker of the generic version of mifepristone, entered the fray this week by suing the FDA. If mifepristone’s license is revoked, the generic version of GenBioPro will also be suspended. The company has argued that if the FDA upholds Kaczmarik’s decision, it will violate the legal process for withdrawing a previously approved drug from use.
“There is a very detailed process for removing drugs from the market,” said Amit Sarpatwari, an assistant professor and professor of medicine at Harvard Medical School. The Kacsmarik governor has interrupted the process, says Sarpatwari. Manufacturers and the FDA have removed drugs from the market before because of low demand or risks to patients, but a court has never stepped in to pull a long-approved drug from service.
Pharmaceutical companies and drug manufacturers say the lower courts’ decision is an unprecedented intrusion on the FDA’s authority. The agency is charged with evaluating, approving and regulating drugs for their safety and effectiveness. If mifepristone is banned or restricted, it puts other drugs at risk, particularly those vulnerable to political pressure, such as hormonal birth control, preventive HIV drugs and vaccines.
Executives from more than 600 biotech and pharmaceutical companies have signed a letter warning that taking mifepristone off the market will have a chilling effect on innovation. Companies often pour billions of dollars through the development pipeline to find a drug, and are loathe to have their investment wiped out in court. “You can see a decline in investment because of uncertainty about whether or not the courts will act on drugs that are decades old,” says Sarpatwari.
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