the united states supreme The court on Friday 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 standstill regulations until the case moves through the appeals process, which could take months.
The court’s final ruling could be the most important decision on reproductive rights since its inception. tipping over Roe vs. 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 in a two-drug series used in a medical abortion, which now accounts for more than half of all abortions through the country. Access to medical abortion is already limited in 15 states.
But on April 7, Judge Matthew Kacsmaryk of the Northern District of Texas ruled to rescind the pill’s nationwide approval. The plaintiffs in the case, anti-abortion doctors, argued that the drug is not safe and that the FDA authorization was improper 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 confirmed that it has a very low rate of serious complications.
The following week, the Court of Appeals for the Fifth Circuit partially blocked Kacsmaryk’s decision, allowing the pill to maintain its FDA approval but striking down several changes the agency had made in recent years to expand access. to her. Among them: pandemic-era provisions that made mifepristone easier to obtain prescribe online and distribute by mail and a 2016 change that allowed taking the pill 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. Over the past week, the Supreme Court issued two separate short-term holding as considered the matter. The court had set a deadline of Wednesday at midnight to decide whether the pill would face tougher rules while the appeal progresses, but extended that deadline to today.
GenBioPro, the maker of a generic form of mifepristone, came on the scene this week with a lawsuit against the FDA. If the approval of mifepristone is revoked, the generic version of GenBioPro would also be discontinued. The company claims that if the FDA complies with Kacsmaryk’s ruling, it would violate established legal process for withdrawing a previously approved drug from use.
“There is a very detailed procedure for taking drugs off the market,” says Ameet Sarpatwari, an attorney and assistant professor of medicine at Harvard Medical School. Kacsmaryk’s ruling circumvents that established process, Sarpatwari says. Manufacturers and the FDA have withdrawn drugs from the market beforeeither because of low demand or because of the dangers to patients, but a court has never stepped in to withdraw the use of a long-approved drug.
Pharmaceutical companies and drugmakers say the lower court rulings represent an unprecedented intrusion into the FDA’s authority. The agency is tasked with reviewing, approving, and regulating drugs for their safety and effectiveness. They say that if mifepristone is banned or restricted, endangers other drugsparticularly those vulnerable to political pushback, such as hormonal birth control, HIV preventative drugs, and vaccines.
More than 600 executives from biotech and pharmaceutical companies have signed a letter warning that removing mifepristone from the market would have a negative effect on innovation. Companies often spend billions of dollars to get a drug through the development pipeline, and would hate to see their investment voided by the courts. “You could see a decline in investment due to uncertainty about whether or not courts are going to take action on decades-old drugs,” says Sarpatwari.
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