The American Supreme On Friday, the court temporarily blocked a lower court order that would have banned the abortion pill mifepristone. The action means the drug will remain available and legal under status quo regulations until the case progresses through the appeals process, which could take months.
The court’s final decision could be the most consequential decision on reproductive rights since its reversal of Roe vs. Wade in June 2022.
Mifepristone has been available in the United States since 2000, when the United States Food and Drug Administration approved its use. It is the first dose of a series of two drugs used in medical abortion, which now represents more than half of all abortions Across the country. Access to medical abortion is already restricted in 15 states.
But on April 7, Judge Matthew Kacsmaryk of the Northern District of Texas ruled to overturn the pill’s nationwide approval. The plaintiffs in the case, anti-abortion doctors, argued that the drug is unsafe and that FDA clearance was improper because pregnancy is not a disease. However, the drug has a decades-long safety history and a comprehensive review conducted by the National Academies of Sciences confirmed to have a very low rate of serious complications.
The following week, the Fifth Circuit Court of Appeals partially blocked Kacsmaryk’s decision, allowing the pill to retain FDA approval, but reversing several changes made by the agency in recent years to expand access. . Among them: pandemic-era provisions that made it easier to prescribe 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 manufactures mifepristone, asked judges to intervene. Over the past week, the Supreme Court issued two separate short-term stays as it considered the matter. The court had given itself a deadline of midnight Wednesday to decide whether the pill would be subject to stricter rules while an appeal progressed, but extended that deadline until today.
GenBioPro, the maker of a generic form of mifepristone, entered the fray this week with a lawsuit against the FDA. If mifepristone’s approval were revoked, the generic version of GenBioPro would also be suspended. The company alleges that if the FDA complies with Kacsmaryk’s decision, it would violate established legal process to remove a previously approved drug from use.
“There is a very detailed procedure for removing drugs from the market,” says Ameet Sarpatwari, a lawyer and assistant professor of medicine at Harvard Medical School. Kacsmaryk’s decision circumvents this established process, Sarpatwari says. Manufacturers and the FDA have pulled drugs from the market before, either because of low demand or because of harm to patients, but a court has never intervened to pull a long-approved drug.
Pharmaceutical companies and drugmakers say the lower court rulings represent an unprecedented intrusion on FDA authority. The agency is responsible for reviewing, approving and regulating drugs for their safety and effectiveness. They say that if mifepristone is banned or restricted, it puts other drugs at risk, especially those that are vulnerable to political pressure, such as hormonal contraceptives, HIV preventative drugs and vaccines.
More than 600 executives from biotechnology and pharmaceutical companies have signed a letter warning that removing mifepristone from the market would have a chilling effect on innovation. Companies often spend billions of dollars to get a drug through the development pipeline, and they would hate to see their investment reversed by the courts. “You might see a decrease in investment due to uncertainty over whether or not the courts will take action against decades-old drugs,” Sarpatwari said.
