Supreme of the United States of America A court on Friday temporarily blocked a lower court order banning the abortion drug mifepristone. This action means that the drug will remain available and legal under the status quo regulations until the case is resolved through the appeals process, which can take months.
The court’s final decision may be the most important reproductive rights decision since it Reverse Roe v Wade in June 2022.
Mifepristone has been available in the United States since 2000, when the US Food and Drug Administration approved it for use. This is the first in a series of two drugs used in medical abortions, which now account for more than half of abortions nationwide. Access to medical abortions has been restricted in 15 states.
But on April 7, Judge Matthew Kacsmaryk of the Northern District of Texas ruled that the drug was approved nationwide. The plaintiffs in the case, anti-abortion doctors, argued that the drug was unsafe and that FDA approval was inappropriate because pregnancy is not a disease. However, the drug has a decades-long track record for safety and Comprehensive assessment conducted by the National Academy 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 decision to allow the drug to be approved by the FDA but overturned some changes the agency had made in recent years to expand access it. Among them: provisions in times of pandemic that make mifepristone easier online prescription And delivery by postand a 2016 change to allow the pill to be taken until the tenth week of pregnancy.
The US Department of Justice, which represents the FDA, and New York-based Danco Laboratories, the company that makes mifepristone, asked the judges to intervene. In the past week, the Supreme Court has issued two divide short-term holding when it is considered problematic. The court gave itself a deadline before midnight Wednesday to decide whether the pill would face stricter rules while the appeal was underway, but the court extended that deadline to Today.
The maker of a generic form of mifepristone, GenBioPro, entered the fray this week with a lawsuit against the FDA. If the approval of mifepristone is revoked, its original version will also be suspended. The company alleges that if the FDA complied with Kacsmaryk’s ruling, it would violate the established legal process to withdraw a previously approved drug from use.
“There is a very detailed process for removing drugs from the market,” said Ameet Sarpatwari, an attorney and assistant professor of medicine at Harvard Medical School. Sarpatwari said that Kacsmaryk’s measures to circumvent the ruling broke the established process. Manufacturers and FDA have remove the drug from the market beforebecause of danger to patients or because of low demand, but the court has never intervened before to revoke a long-approved drug.
Pharmaceutical companies and drugmakers say the lower court rulings represent an unprecedented violation of FDA’s authority. The agency is tasked with reviewing, approving, and regulating drugs for their safety and effectiveness. They say if mifepristone is banned or restricted, It also puts other drugs at riskespecially those areas that are vulnerable to political pushback, such as hormonal birth control, HIV prevention drugs, and vaccines.
More than 600 executives from biotech and pharmaceutical companies signed a letter warned that pulling mifepristone off the market would have a cooling effect on innovation. Companies often spend billions of dollars to get a drug through the development process and hate having their investment dropped by the courts. “You might see investment drop due to uncertainty over whether the courts will act on drugs that have been around for decades,” says Sarpatwari.
