Updated December 13, 2023 at 10:21 AM ET
The U.S. Supreme Court Wednesday, agreeing to review a lower court decision that would make mifepristone, the commonly used abortion pill, less accessible.
The court's action sets up a collision between the Food and Drug Administration's 23-year study and supervision of the abortion pill, and the circumstances under which it can be prescribed. Mifepristone was first approved by the FDA in 2000; the agency required the drug to be prescribed in person, over three visits to a doctor. Since 2016, however, the FDA has eased that regimen, allowing patients to obtain prescriptions through telemedicine appointments, and to get the drug by mail.
The clash over the abortion pill began April 7 in Texas when U.S. District Judge Matthew Kacsmaryk, a onetime anti-abortion activist, imposed a nationwide ban on mifepristone, declaring that the FDA had improperly approved the drug 23 years ago. Within minutes of that decision, U.S. District Judge Thomas O. Rice in Washington state issued a contrary ruling. In a case brought by 17 states and the District of Columbia seeking to expand the use of mifepristone, Rice declared that the current FDA rules must remain in place, and noted that in 2015 the agency had approved a change in the dosing regimen that allowed the drug to be used for up to 10 weeks of pregnancy, instead of the earlier seven weeks.
While the case ricocheted around the lower courts, the Supreme Court, over two noted dissents, put the lower court decisions on hold, allowing the abortion pill to continue on the market as it had been.
While the court considers the case, the medication will remain available as it has been.
The Alliance for Hippocratic Medicine argues they have the authority to bring the case because "FDA always envisioned that emergency room doctors...would be a crucial component of the mifepristone regimen." Because they would suffer if they have to treat patients who have taken medication abortion, they argue they should have the right to challenge the medication's safety.
The Biden administration that the group failed to show "any evidence of injury from the availability" of the medication.
Danco, the maker of abortion pill Mifeprex, is on the government's side. It says the key question in the case is whether courts can "overrule an agency decision they dislike." The antiabortion doctors, Danco argues, have no authority to bring the case. They "do not prescribe or use the drug" and their only "real disagreement with FDA is that they oppose all forms of abortion," Danco writes.
The group challenging the FDA claims that when the agency made the drugs more accessible, they exceeded their power and regulatory safeguards.
On the other hand, the government says that the drug has been deemed "safe and effective" since 2000. In its brief, the government says the FDA has "maintained that scientific judgment across five presidential administrations, while updating the drug's approved conditions of use based on additional evidence and experience," including the over five million patients who have taken it.
The Fifth Circuit's decision "threatens to undermine the FDA's scientific, independent judgment and would reimpose outdated restrictions on access to safe and effective medication abortion," White House spokeswoman Karine Jean-Pierre said in a statement. "This Administration will continue to stand by FDA's independent approval and regulation of mifepristone as safe and effective."
The case will be heard this term, with a decision likely by summer.
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