Federal Judge to Weigh in on FDA Approval of Abortion Pill

AUCKLAND, NEW ZEALAND - FEBRUARY 17: The abortion drug Mifepristone, also known as RU486, is pictured in an abortion clinic February 17, 2006 in Auckland, New Zealand. The drug, which has been available in New Zealand for four years and is used in many countries around the world, is expected to be available to Australian women within a year after parliament yesterday approved a bill which transfers regulatory control of the drug to the Therapeutic Goods Administration, a government body of scientists and doctors that regulates all other drugs in Australia. (Photo by Phil Walter/Getty Images)

The national abortion landscape is poised to undergo another seismic change, as a federal judge in Texas weighs a case concerning the ability to access abortion pills.

The looming ruling, which could come later this month, will determine whether the decades-old Food and Drug Administration approval of mifepristone, the first of two medications used to terminate early-stage pregnancies, should remain in place, along with newer initiatives from the agency that make the medication more accessible.

The challenge was brought by a group of anti-abortion medical organizations in November, which argued that the FDA had overstepped its authority when it approved the medication in 2000. And although the Biden administration has pledged to fight any decision restricting access to medication abortion, which accounts for more than half of abortions nationwide, the legal battle could be long fought, perhaps bringing another major abortion decision before the Supreme Court.

Since the Supreme Court decision that gutted the constitutional right to an abortion in June, medication abortion has taken on new meaning for activists on both sides of the issue – seen by abortion rights advocates as a critical avenue for abortion access and by those who oppose abortion, who often refer to the pills as “chemical abortion,” as the next battleground.

“After two decades of engaging the FDA to no avail, Plaintiffs now ask this Court to do what the FDA was and is legally required to do: protect women and girls by holding unlawful, setting aside, and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen,” lawyers representing the anti-abortion groups wrote in the challenge to the FDA’s approval of the medication.

The groups also asked the judge to reverse a number of recent FDA actions making the medication more accessible, including the ability to receive the pill by mail.

The decision from U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas, a Trump-appointee known for his conservative stance, is expected after both sides submit their briefs, as soon as Feb. 24, after a Feb. 10 deadline was pushed back. The judge ordered the extension late Thursday to grant the distributor of the abortion pill time to submit arguments against the reversal of the FDA approval.

A ruling reversing the FDA’s approval would have implications far beyond Texas, where the procedure is already heavily restricted, affecting states where abortion remains legal.

At present, 12 states have made abortion illegal, while a number of other states impose some limits on medication abortion. According to a recent analysis from the Guttmacher Institute, a pro-abortion rights research organization, while the decision would affect all states where abortion remains available, it would differ greatly between states, and would be most pronounced in Colorado, Georgia, Indiana, Iowa, Maine, Montana, New Mexico, Pennsylvania, Vermont and Washington.

“Without medication abortion using mifepristone as an option, demand for procedural abortions could increase significantly – leading to overwhelmed clinics and providers, much longer wait times, further unnecessary delays, and more complicated and costly logistics for many patients,” the analysis says.

Accordingly, some abortion providers throughout the country are reportedly preparing to employ an alternative to the two-dose regimen that studies say has a slightly higher rate of failure and more intense side effects than the two-dose regimen – using misoprostol, the second medication in the series, to terminate early-stage pregnancies alone.

The looming decision comes as Americans are more dissatisfied with abortion policy than they have been since 2001, at nearly 70%, according to a Gallup poll released Friday. And among those who are dissatisfied, individuals are three times as likely to prefer less strict abortion policies.