A federal judge stopped the Food and Drug Administration from approving the abortion pill on 7 April. This could make it harder for women to get the most common way to end a pregnancy.
In a 67-page ruling, U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas, said that the FDA made a number of legal mistakes when it gave the go-ahead for the pill to be sold in the U.S.
The judge stopped approval of the mifepristone drug, but his decision won’t take effect for a week while the Biden administration appeals and tries to get an emergency stay.
The judge said that the people who sued the FDA because they didn’t like abortions were likely to win because they said the FDA did something wrong when it put the pill on the market by using a process meant for drugs that treat serious illnesses.
He also said that the agency didn’t do a good job of making sure the drug was safe. Judge Kacsmaryk, a Trump appointee said –
“The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions.”
The judge’s decision is the first step in what could be a series of quick court cases. Within hours of the ruling, both the Justice Department and the company that made the drug, Danco Laboratories LLC, went to court to appeal.
If a higher court doesn’t stop the decision, it could stop drug sales even in states where abortion has been legal since the Supreme Court overturned Roe v. Wade last June.
Attorney General Merrick Garland said that the Justice Department strongly disagreed with the decision. Mr. Garland said –
“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective.”
The plaintiffs were represented by a conservative legal group called Alliance Defending Freedom, which was very happy with the decision. It said on Twitter –
“This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.”
A different federal judge in Washington state made a different decision, adding to the confusion. This could stop the FDA from limiting access to the pill in the 17 states and the District of Columbia that had sued the agency to keep access open.
Since the Supreme Court took away constitutional protections for abortion and gave states a lot of freedom to limit or keep abortion as they see fit, this case has been one of the most closely watched fights.
Since abortion clinics have closed in about a third of the states, access to abortion pills has become a key battleground. Some states have made it illegal to prescribe abortion pills by telemedicine and put other restrictions in place. Groups that support abortion, on the other hand, have filed lawsuits saying that federal law overrides these state rules.
In 2000, the FDA gave its approval to mifepristone, which is also sold by Danco under the brand name Mifeprex. The agency said that studies had shown that using it was safe and helpful. GenBioPro Inc. makes one that is generic.
Danco spokeswoman Abby Long said –
“Today’s decision is wrong on the medicine and science, wrong as a matter of public health policy, wrong as a matter of reproductive rights and wrong as a matter of law.”
The drug stops a hormone that is needed to keep a pregnancy going. It is now used in more than half of all abortions in the U.S.
The lawsuit was filed by a group of doctors and doctors’ groups that are against abortion in November of last year. They said that the FDA didn’t take into account the drug’s risks, didn’t test how safe it was for girls, and approved the drug using a process that was only meant for emergencies.
One of the plaintiffs, the American Association of Pro-Life Obstetricians and Gynecologists, said in a statement –
“Today’s ruling places women’s welfare back at the forefront of the conversation on this issue.”
“Our patients deserve excellent healthcare and fully informed consent, this decision helps ensure they receive that.”
Lawyers for the federal government have said that the FDA approved the drug because it is safe and works well. They also said that stopping the drug from being sold would upset the status quo and hurt patients.
Vice President Kamala Harris said the decision “threatens the rights of women nationwide to make decisions about their health care and the ability to access medication prescribed to them by their doctors.”
After taking mifepristone, women usually take one or two doses of misoprostol, which makes the uterus contract. This is done a day or two later.
Misoprostol is not changed by Judge Kacsmaryk’s decision. Experts in public health and groups that support abortion rights say that women who want an abortion can now take misoprostol alone.
Researchers have found that taking misoprostol alone can end a pregnancy, but it doesn’t work as well as when taken with mifepristone.
Suzanne Bell, a professor at the Johns Hopkins Bloomberg School of Public Health said –
“This will not stop medication abortions from occurring in the U.S. It will simply force healthcare providers to rely on the misoprostol-only regimen, which, while still very safe, is somewhat less effective and causes more uncomfortable side effects.”
Rarely does a judge step in to change a decision made by the FDA, especially about a drug that has been on the market for a long time. At a hearing in Texas in March, lawyers for the plaintiffs admitted that they couldn’t give any examples of a court getting involved in the approval of a drug that had been on the market for a long time.
However, they did give examples of cases involving drugs that were newer to the market. Judge Kacsmaryk said that the FDA was to blame for the plaintiffs not getting their day in court until many years after the drug had been on the market. He wrote –
“Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.”
Before being put on the federal bench in 2019, the judge worked at a conservative legal group that focused on religious issues. In another important decision he made last year, he said that a federal program that gave out birth control was against parents’ rights because it let minors get birth control without their parents’ permission. Case is being appealed.
The case about the abortion pill is now going to the Fifth U.S. Circuit Court of Appeals in New Orleans. This is one of the most conservative appeals courts in the country. Once that court decides on the stay request from the Biden administration, the case could soon be brought to the Supreme Court as an emergency case.
In Washington state, Obama’s choice for U.S. District Judge, Thomas Rice, agreed with a group of Democratic state attorneys general who sued the FDA to make it easier for women to get the abortion pill.
For now, the judge stopped the agency from enforcing some new rules about mifepristone and told the FDA not to put any more rules on the pill in the plaintiff states. This could cause a conflict with the Texas ruling.
