A lawsuit before a federal judge in Texas seeks to upend a federal public health agency’s longtime approval of medication abortion. The challenge threatens access to such drugs even in states where abortion is legal.
After the Supreme Court ended the constitutional right to an abortion last summer, some believed the decision would only intensify the legal battles over abortion access. One group that worked to overturn Roe v. Wade filed a lawsuit in Texas seeking to reverse the U.S. Food and Drug Administration’s decades-long approval of the drug mifespristone, which is used in combination with another drug, misoprostol, to terminate pregnancies up to 10 weeks.
“Before a drug can be approved, it has to treat an illness and it has to provide a meaningful therapeutic benefit over existing treatments. But pregnancy is not an illness. It's a normal part of a woman's life,” said Julie Marie Blake, senior counsel for Alliance Defending Freedom, a legal advocacy group that opposes abortion rights.
The group argues the FDA overstepped its authority and its approval process back in the year 2000 was unlawful.
“Our case is filed on behalf of emergency room doctors, local OBs, medical associations who've been standing up to the FDA since the beginning when President (Bill) Clinton pushed this drug approval through in 2000,” Blake said. “When it comes to chemical abortion drugs, the FDA has completely failed.”
The case is before Judge Matthew Kacsmaryk, the Trump-appointed federal judge in Amarillo, and if he agrees it could mean the pills would be unavailable nationwide.
“That means people in every state — including California, Illinois and New York — will not be able to get abortion pills. Medication abortion is incredibly safe and has been used in the U.S. for more than 20 years. And more than half of abortions in the U.S. are done using medication abortion. The science and evidence is indisputable,” Jenny Ma, senior counsel at the Center Reproductive Rights, said in a statement to Spectrum News.
In court filings, attorneys with the FDA and the U.S. Department of Health and Human Services called the request to take the drugs off the market “extraordinary and unprecedented.” They also said the approval was based on “extensive scientific evidence.”
“It has been in use in the United States for over 20 years. It's been used by millions of people, and it has a very strong safety profile. So there's no reason to believe that this drug is not safe, counter to the arguments that the plaintiffs in the case are making,” said Kari White, lead investigator at the Texas Policy Evaluation Project at the University of Texas at Austin. “When drugs go before the FDA, they usually they need to have scientific evidence from medical studies showing that the drug is safe and effective for the purposes for which it is being approved. Mifepristone met those criteria.”
Medication abortions account for more than half of abortions across the country, according to the Guttmacher Institute, which supports abortion rights.
Roe’s fall triggered a ban on most abortions in Texas, with one exception to save the life of the patient. Even with abortion restrictions in place, TxPEP researchers found that patients still wanted an abortion even if they could not obtain one at a Texas clinic. They found, in part, how pregnant Texans sought abortion pills online, out of state or out of the country.
“What we have seen here in Texas, as well as I think what we see across the globe is that these types of restrictions do not do anything to change people wanting to end their pregnancies and people's need to have safe methods by which to do so,” White, who is also an associate professor at UT social work and sociology departments, said. “People are going to look for ways to try to end their pregnancies even if this medication is not available. Unfortunately, it's taking away a very safe and effective option if the lawsuit were successful.”
A ruling is expected shortly after a filing deadline of Feb. 24 and the decision would likely be appealed.