The U.S. Supreme Court will hear arguments on Tuesday in a case that could change how people can get mifepristone, a drug that is often used to cause abortions. Since Roe v. Wade was overturned in 2022, this is the first big abortion case the high court has taken.
Amarillo was the first place where the case was brought. There, a conservative federal judge named Matthew Kacsmaryk agreed with anti-abortion groups that wanted to take mifepristone off the market almost a year ago. After that, the Supreme Court stopped any changes to the law regarding the drug until it had a chance to hear the case.
A group of doctors who are against abortion called the Alliance for Hippocratic Medicine filed the first lawsuit in November 2022. They said that the U.S. Food and Drug Administration did not properly test mifepristone for safety before approving it in 2000 or easing limits on it in 2016 and 2022.
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In their filings, the FDA and Danco Laboratories, the company that makes mifepristone, say that there is a lot of proof that the drug is safe and works. They also say that the Alliance for Hippocratic Medicine doesn’t have the right to file this suit because the approval of the drug hasn’t hurt any of its members.
The Next Frontier
When the U.S. Supreme Court overturned Roe v. Wade in June 2022, Justice Samuel Alito said that he hoped that letting states make their own abortion rules would keep the high court from having to review the case over and over again.
Roe v. Wade and Casey v. Wade, two important decisions about abortion made in 1973 and 1992, respectively, “far from bringing about a national settlement of the abortion issue, they have enflamed debate and deepened division,” Alito wrote. “It is time to follow the Constitution and give the fight over abortion back to the people’s elected officials.”
But now, less than two years later, the nine judges are again talking about abortion. The question in this case is not as important as the one that overturned Roe v. Wade in 2022, but the decision would still have big effects on people all over the country’s ability to get abortions.
In the United States, the most common way to have an abortion is to take a medicine mix of mifepristone and misoprostol to end a pregnancy up to 10 weeks. It has less risk than surgery, and while people can take misoprostol by itself, it has been shown that taking it with another drug is more successful and has less risk.
More than a dozen states have banned or greatly limited abortion. Now, both sides of the abortion debate are focusing on getting access to mifepristone. In Texas, it is against the law to mail pills that cause abortions, but foreign providers and groups from other states are still finding ways to get the pills to people.
Timeline of the Case
Since mifepristone was allowed in 2000, groups that are against abortion have been fighting against this very thing. At first, some of these groups put together a citizen petition in 2002 to fight the decision. Not until 2016 did the FDA react. They turned down the petition on the same day they announced new rules that let the drug be used for 10 weeks of pregnancy instead of the original 7.
The FDA approved a generic version of mifepristone in 2019. In January, after relaxing some rules during the pandemic, the agency permanently lifted the in-person dispensing requirement. This meant that the medicine could be prescribed through telehealth appointments, given out at retail pharmacies, and mailed.
The groups that are against abortion say that everything was wrong, starting with the acceptance in 2000. In April of last year, Kacsmaryk agreed and wrote an opinion full of anti-abortion language. He called abortion providers “abortionists” and said that the process was like “starving the unborn human until death.”
“The Court doesn’t guess how the FDA made its decision,” Kacsmaryk wrote. “But in this case, FDA gave in to its legitimate safety concerns, which was against the law, based on clearly flawed reasoning and studies that did not support its conclusions.”
With Kacsmaryk’s decision, mifepristone would no longer be approved and could not be sold in the United States. But before it could go into action, the 5th U.S. Circuit Court of Appeals stepped in and stopped some of the new rules that would have let generic mifepristone be sold and telemedicine prescribing happen.
This meant that mifepristone could stay on the market. That’s when the Supreme Court stepped in and said the rules for mifepristone would not change until the case was over.
Aside from the issue of abortion access, this case has caused worry in the whole pharmaceutical business.
A law professor at the University of Pittsburgh who studies FDA law told The Texas Tribune in April, “This is the first time a judge has taken a drug off the market without the FDA’s permission.” “A judge who doesn’t know much about science rules over an agency that does know a lot about science.”
In his decision, Kacsmaryk also brought up the Comstock Act, a 150-year-old rule that says you can’t use the U.S. postal service to mail anything about abortion. The law is still in effect, but it hasn’t been used in decades. Anti-abortion groups want the Comstock Act to be used to control the mailing of abortion drugs, but lawyers say it could have much more serious effects, like stopping the mailing of all medical items.
The 5th Circuit agreed with Kacsmaryk’s understanding of the Comstock Act. This is another area of law where the Supreme Court needs to decide what the law is.
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