New Discordant Rulings On Abortion Pill: Will the Supreme Court Intervene?
How competing orders muddle the waters
This past week, two federal judges made contradictory orders regarding mifepristone, a popular abortion pill used up to 10 weeks in pregnancy, according to BBC News.
Texas Judge Matthew Kacsmaryk, appointed by Trump, ordered a hold on mifepristone’s FDA approval. Washington Judge Thomas O. Rice, appointed by Obama, then ordered the preservation of the drug’s approval status in 17 states.
The rulings came within an hour of one another.
Almost 10 months have passed since the Supreme Court overturned Roe v. Wade, tossing deciding power to the states with Dobbs v. Jackson Women’s Health Organization.
Dobbs triggered an explosion of legislative efforts to both protect and ban abortion throughout the United States. The abortion pill is in the ring, but it is unclear whether or not it will knock out its dissenters and win preserved approval.
According to the FDA, mifepristone has been approved for about 23 years. The Texas ruling has no precedent, so what is it a response to?
Here are some key takeaways from the Texas opinion on the FDA’s handling of mifepristone:
FDA approval for mifepristone was put forth quickly under Subpart H, or “accelerated approval.” The Plaintiffs’ complaint is one of negligence: mifepristone’s approval lacked sufficient testing to ensure the drug’s safety for women.
In 2006, the U.S. House Subcommittee on Criminal Justice, Drug Policy, and Human Resources even held an investigative hearing into the FDA’s handling of mifepristone. The Chairman at the time claimed that the drug was “associated with the deaths of at least 8 women, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.” Almost 1,000 adverse event cases were reported in total.
Judge Kacsmaryk claims that the FDA “stonewalled judicial review,” ignoring the Plaintiffs’ petitions for over 16 years. By law, the agency must respond within 180 days, but the FDA failed to do so (21 C.F.R. § 10.30(e)(2)). Instead, they waited a total of almost 6,000 days.
The day that the FDA did come around to rejecting the 2002 petition (in 2016), they also removed post-approval safety restrictions for pregnant women, increased the maximum gestational age from 7 to 10 weeks, reduced the required number of in-person visits from three to one, allowed for non-doctors to prescribe and give the drug, and eliminated the requirement to report any non-fatal adverse events. This final policy change comes across as particularly strange if mifepristone is, in fact, proven safe for women as its approval indicates.
The FDA’s Covid-era introduction to mailing mifepristone was in direct opposition to the Comstock Act, which bans the mailing of abortion-inducing substances.
This week’s rulings clearly conflict with one another, but there is a period of seven days before Judge Kacsmaryk’s ruling takes effect. This allows time for the government to appeal the order.
The Biden Administration will likely do so, but the Texas ruling could be upheld in the 5th Circuit of Appeals. The Supreme Court can also intervene and choose which order to uphold, given the national spotlight on the issue.
The issue at stake is if precedent stands or if the FDA should answer for negligence.