This Texas lawsuit could halt access to an abortion drug nationwide. Here’s what to know

Although abortion has been illegal in Texas since last year, a case filed in federal district court in Amarillo could still radically alter the reproductive health landscape in the state and across the nation.

Reproductive health experts are watching a case that could determine the future of mifepristone, one of two drugs used in medication abortions and which is also used to treat miscarriages.

The case stems from a lawsuit brought by a group of anti-abortion doctors and organizations, who argue that the Food and Drug Administration improperly approved mifepristone when the drug was first approved in 2000. The plaintiffs are asking Judge Matthew Kacsmaryk to vacate the FDA’s approval of the drug, an action that drug experts believe has never happened before in the history of U.S. drug regulations.

“I’ll fall out of my chair If the FDA is forced to rescind approval for this product based on this case,” said Dr. Caleb Alexander, professor of medicine and epidemiology at the Johns Hopkins University Bloomberg School of Public Health. “It would mark a striking departure from the regulatory system that we have built over more than a century.”

Lawyers for the plaintiffs and the Food and Drug Administration must file updated briefs by Friday, after which Kacsmaryk is expected to issue his ruling. Depending on the wording and context of Kacsmaryk’s ruling, access to mifepristone could be halted, at least temporarily, in states across the nation, regardless of whether abortion remains legal in those states. The ruling could also mean that women experiencing miscarriages might not be able to access mifepristone, which is commonly prescribed when patients opt for medication management of their miscarriage.

And drug experts worry that such an overturn of the FDA’s process could threaten thousands of other drugs that have already been approved by the federal body.

Here are answers to some basic questions the case raises.

What is a medication abortion? What do we know about mifepristone?

In the U.S., medication abortions typically involve taking two drugs. First, a patient takes mifepristone, the drug that plaintiffs are challenging in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. Guidelines recommend taking 200 mg of mifepristone, usually followed by a second drug, misoprostol, between 24 and 48 hours later.

Although the rate of abortions has declined in the U.S. since a peak in the 1980s, medication abortions have become increasingly popular among people seeking to end a pregnancy. In 2020, abortion pills were used in more than half of all legal abortions, according to research from the Guttmacher Institute, a group that supports abortion access. (The use of abortion pills likely increased in 2020 because of the COVID-19 pandemic, which closed abortion clinics in some states.)

Since it was approved in 2000, mifepristone has been highly regulated and monitored by the FDA. Of 3.7 million medication abortions reviewed by the FDA over 18 years, less than 0.03% of women were hospitalized after taking the drugs.

Dr. Eleanor Schwarz,a professor of medicine at the University of California, San Francisco’s medical school, said the drug is one of the safest medications ever approved by the FDA, and has fewer risks than over-the-counter medications like Tylenol.

One of the most comprehensive reviews of abortions in the U.S. was published by the National Academies of Science, Engineering and Medicine in 2018. The report, which represents a consensus of top experts in the field, concluded that all four types of abortion that were used in the U.S. were safe, including medication abortion.

“Complications after medication abortion, such as hemorrhage, hospitalization, persistent pain, infection, or prolonged heavy bleeding, are rare — occurring in no more than a fraction of a percent of patients,” the authors wrote.

Although there are potential risks to mifepristone, they are well understood and documented, Alexander, the Johns Hopkins professor.

“It’s not like the jury is still out on this product,” Alexander said. “This may be a political debate, but I don’t think there is a scientific debate about whether or not this product has met the bar for being available on the market.”

Is abortion legal in Texas?

No. Virtually all abortions have been illegal in Texas since last year, when the Supreme Court overturned the constitutional right to abortion and allowed states to determine whether it would be illegal. The Supreme Court’s ruling triggered a state law in Texas that made almost all abortions illegal.

There is an exception for cases in which a pregnant woman’s life is in danger, but doctors have said that the language in the law is unclear, and could be interpreted differently depending on the doctor or hospital where someone is being treated. Texas law does not have exceptions for cases rape or incest.

Texas law applies to all types of abortions, including medication abortions.

Some pregnant Texans are still receiving abortions since the law changed last year.

Pregnant Texans are still receiving abortions. Some are traveling to clinics in states where abortion remains legal, or else are ordering medication abortions through online pharmacies or other international providers.

Are medication abortions and emergency contraception, like Plan B, the same thing?

No. Medication abortions are abortions induced by medications that end a pregnancy.

Emergency contraception, like Plan B, does not end a pregnancy, but rather prevents a pregnancy from happening in the first place, according to the FDA. Most emergency contraceptives prevent pregnancy by preventing a fertilized egg from implanting into the uterus. Emergency contraception like Plan B can be bought at pharmacies without a prescription in Texas.

How could a ruling in this case affect abortions in Texas?

If Kacsmaryk’s ruling threatens access to mifepristone in Texas, there would be no immediate change to the legality of abortions in Texas. Abortions of all kinds in the state, including medication abortions that use mifepristone, are already illegal.

But Kacsmaryk’s ruling could still affect Texans who need mifepristone for other reasons, like to treat a miscarriage. A miscarriage is any spontaneous end to a pregnancy before the 20th week of pregnancy. Typically, patients who miscarry have two options, according to maternal health experts: They can opt for medication management, like taking mifepristone and misoprostol, to help them pass the tissues, or they can opt for “expectant management,” and wait for the tissue to pass naturally. In some cases, women might undergo a surgical procedure after a miscarriage.

Outside of Texas, a ruling could prevent access to mifepristone in states where abortion remains legal, as well as patients who might be prescribed mifepristone for miscarriages. U.S. officials have already said they would appeal a ruling that would limit access to the drug, so a final decision on the drug might not happen for months or even years. But a ruling that overturns the FDA approval process could leave other drugs subject to litigation, said Liz Borkowski, a researcher at the Milken School of Public Health at George Washington University.

“I think some people don’t recognize the existential threat this poses to how we have drugs approved in this country,” Borkowski said. “If a judge can overturn an FDA decision that is based on extensive collection of evidence and deliberation, then that has really serious consequences for all of us who rely on any kind of medical care, which is basically all of us.”