A lawsuit filed in a Texas federal district court is aiming to limit Americans’ access to mifepristone, commonly referred to as the abortion pill. Anti-abortion advocates say the U.S. Food and Drug Administration (FDA) should rescind its approval of the medication until it can be adequately tested.
“The FDA has one job, which is just to protect Americans from dangerous drugs,” said Denise Harle, senior counsel with the Alliance Defending Freedom, one of the conservative-leaning groups that brought the lawsuit. “We’re asking the court to remove that chemical drug regimen until and unless the FDA actually goes through the proper testing that it’s required to do.”
Mifepristone was approved by the FDA in 2000 and blocks hormones necessary for pregnancy. It can induce an abortion up to 10 weeks into a pregnancy. It must be followed by a second drug, misoprostol, which was approved by the FDA in 1988 to treat gastric ulcers.
In public comments, Harle argued that the FDA originally approved the use of mifepristone under a provision that should only be used to approve medications that treat an illness. Pregnancy, she said, is a condition that should not qualify. However, Harle has also said in interviews that she does not want to see the drug on the market at all. “I think chemical abortions do great harms to women and their unborn children, and that’s what this lawsuit is really about,” she told PBS NewsHour.
The Texas lawsuit will be decided by U.S. District Judge Matthew Kacsmaryk, a Trump appointee who is known to have anti-abortion views. If he rules in favor of rescinding the FDA’s approval, drug manufacturers would no longer be able to ship mifepristone anywhere in the U.S., including states where abortion is legal. Research suggests that medication abortion currently accounts for more than half of U.S. abortions.
Some medical providers who oppose restricted access to the abortion pill have suggested the solo use of misoprostol, the second in the two-drug regimen, as a means to assist women seeking medication abortions, should mifepristone become unavailable.
“There are workarounds,” Rachel Carmona, executive director of the Women’s March, told PBS NewsHour. “But, you know, obviously, I feel very strongly that we should not need to use workarounds to access lifesaving health care.”
Others in the medical field also argue that using misoprostol alone can come with risks, including a higher chance of side effects. “It’s so important that patients understand how long they’ll be bleeding after they take the miso alone,” Dr. Ushma Upadhyay, a public health professor at the University of California San Francisco, told NPR. “And it is longer.”
Upadhyay added that without mifepristone, advising patients, especially patients who might have traveled to an abortion provider from a state where abortion is illegal, is going to be more challenging.
Some medical providers also point to research that has indicated that misoprostol is not as effective alone as the twodrug regimen. President Biden has come out in support of maintaining access to mifepristone, stating that it will defend “women’s fundamental freedoms.
“Defending and protecting reproductive rights is essential to our nation’s health, safety and progress,” Biden said in a statement. “It is the policy of my administration to protect against threats to the liberty and autonomy of those who live in this country.” With the possibility of mifepristone’s removal from the American market looming, 12 U.S. states with liberal-leaning attorneys general sued the Food and Drug Administration in late February.
They said the agency’s current limits on mifepristone are too strict and prevent wider access. “The federal government has known for years that mifepristone is safe and effective,” Washington state Attorney General Bob Ferguson said in a statement. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk.
The FDA’s excessive restrictions on this important drug have no basis in medical science.” Not only did this lawsuit aim to make mifepristone more accessible, but it also served as a buffer to the Texas lawsuit, given that a conflicting ruling in the state attorneys general case would mean that the issue would have to be taken to the Supreme Court, which will likely make the final decision on the fate of mifepristone’s availability.
For more background, see the November 2021 issue of Congressional Digest on “Abortion Access.”
