us supreme The court on Friday temporarily stayed a lower court order that would have banned the abortion pill mifepristone. The action means the drug will remain available and legal under the status quo rules until the case works its way through the appeals process, which could take months.
The court’s final decision could be the most consequential decision on reproductive rights since its overturning 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. This is the first dose of a two-drug series used in a medication abortion, which has now become more half of all abortions across the country. Access to medication abortion is already limited in 15 states.
But on April 7, Judge Matthew Kaczmarik of the Northern District of Texas ruled to revoke approval of the pill nationwide. The plaintiffs in the case, anti-abortion doctors, argued that the drug is unsafe and that the FDA’s authorization was inappropriate because pregnancy is not a disease. However, the drug has a decades-long track record of safety, and a Comprehensive review conducted by the National Academies of Sciences confirmed that it has a very low rate of serious complications.
The following week, the Fifth Circuit Court of Appeals partially blocked Kacsmaryk’s ruling, allowing the pill to retain FDA approval, but rolling back many of the changes the agency had made in recent years to expand its reach. Got it. Among them: a pandemic-era provision that made it easier to prescribe mifepristone online and deliver it by mail and a 2016 change that allowed the pill to be taken until the 10th week of pregnancy.
The US Justice Department, acting on behalf of the FDA, and New York-based Danko Laboratories, the maker of mifepristone, asked the judges to intervene. During the last week, the Supreme Court issued two separate short-term holds while considering the matter. The court had given itself until midnight on Wednesday to decide whether the tablet would face stricter rules if the appeal proceeded, but it extended that deadline until today.
GenBioPro, the maker of a generic form of mifepristone, filed a lawsuit against the FDA this week. If the approval of mifepristone is revoked, the generic version of GenBioPro will also be suspended. The company alleges that if the FDA were to comply with Kacsmaryk’s decision, it would violate the established legal process for withdrawing a previously approved drug from use.
“There’s a very elaborate process for removing drugs from the market,” says Amit Sarpatwari, MD, assistant professor of medicine at Harvard Medical School and attorney. Sarpatwari says that the rule of Kaksmrik bypassed that established procedure. Manufacturers and the FDA have removed drugs from the market before because of low demand or dangers to patients, but a court has never moved to remove a long-approved drug from use.
Pharmaceutical companies and drug makers say the lower courts’ rulings represent an unprecedented intrusion into the FDA’s authority. The agency is tasked with reviewing, approving and regulating drugs for their safety and efficacy. They say that if mifepristone is banned or restricted, it puts other drugs at risk, especially those vulnerable to political pushback, such as hormonal birth control, preventive HIV drugs and Vaccines.
Over 600 executives from biotech and pharmaceutical companies signed a letter warned 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 quashed by the courts. “You might see a reduction in investment because of the uncertainty about whether the courts are going to act on decades-old drugs,” Sarpatwari says.
