Less than a year after the conservative court struck down Roe v. Wade, the next phase of the fight over abortion rights is already at the Supreme Court’s doorstep. The case would affect women all over the country, making abortions harder to access even in states where it’s legal.
On Friday, April 7, Judge Matthew Kacsmaryk of the Northern District of Texas ruled in favor that the FDA must reverse its approval of mifepristone, one of the two drugs commonly used in medication-induced abortions. If the ruling stands, and abortion pills no longer have approval from the FDA, doctors, and pharmacists would have to stop providing them — even in states that have passed laws protecting abortion rights. This is simply because pharmacists can only dispense FDA-approved drugs.
A conservative Christian legal advocacy group, known as the Alliance Defending Freedom, filed a lawsuit claiming that mifepristone is unsafe and that the FDA didn’t study it closely enough before approving its use. The FDA and mainstream medical doctors insist this isn’t true, and that there have been no safety concerns during the 23 years the drug has been on the market.
The nationwide injunction of mifepristone is set to take effect by Friday, and may impact as many as 64 million women of childbearing age in the U.S. Currently, over half of U.S. abortions are performed with medication instead of surgery. The FDA initially approved mifepristone in 2000 for use in combination with a second drug, misoprostol. Since then, they have frequently reviewed the drug’s safety warnings and other specifics of its approval.
In addition to its use in abortion care, mifepristone is also currently used for miscarriage care, according to Dr. Gopika Krishna, a board-certified OB-GYN in New York. The plaintiffs had only asked for the judge to block the drug for purposes of abortion, but its possible availability will dry up since its primary purpose was to end a pregnancy.
“This is something that can cause confusion. It’s something that can cause fear,” Dr. Krishna told ABC News. “And that affects our patients and our patients’ understanding of what’s available to them and what options are safe.”
In states where abortion is legal, providers would only be able to offer in-clinic surgical procedures or opt to provide medication abortions using only one other medication, misoprostol. Although these methods are deemed safe and mostly effective, doctors have stated that there can be more side effects.
Because the judge’s ruling applies only to the F.D.A. and not to abortion providers, several medication abortion services have said they will continue prescribing and dispensing mifepristone unless there is an official F.D.A. decision to withdraw the drug that the agency plans to enforce.
However, Kacsmaryk gave the federal government 7 days to file an appeal, but if the injunction stays in place as the full case makes its way through the courts, the F.D.A. will most likely assert that it needs to follow its official process for withdrawing the approval of a drug. This process would be lengthy and requires reviews of extensive studies and data, and could involve advisory committee hearings and a public comment period. Since the process can take months, or even years, the drug being reviewed will remain available while it is underway.
Meanwhile, in Washington: U.S. District Judge Thomas Rice, of the federal district court in Spokane, issued a preliminary injunction that blocked the FDA from “altering the status quo and rights as it relates to the availability of mifepristone,” one of two drugs used in medication abortions. The administration is expected to appeal the Washington state ruling, and both cases could ultimately set the stage for the Supreme Court to ultimately decide.
