The U.S. Supreme Court has agreed to hear an appeal from the Biden administration regarding access to the abortion pill, mifepristone. This could potentially lead to significant changes in access to the drug, even in states where abortion is legally protected. The case, which was granted after the U.S. Court of Appeals for the 5th Circuit ruled that mifepristone can stay on the market, is expected to have major implications for the biopharma industry and the Food and Drug Administration’s approval authority.
The Supreme Court debates abortion pill access
The U.S. Supreme Court has agreed to hear a Biden administration appeal about access to abortion pill mifepristone. The court’s decision, expected in June, could bring significant changes to abortion pill access across states, even where abortion is legal.
Mifepristone, part of a two-drug regimen used to terminate pregnancies within the first 10 weeks, accounts for half of all U.S. abortions according to the Guttmacher Institute.
Background of the case
An appeal from the Justice Department and Danco, Mifeprex’s manufacturer, led to the court’s involvement. This followed a 5th Circuit Court of Appeals ruling that while mifepristone could remain on the market where legal, FDA changes since 2016 to ease drug access were invalid. These changes included increasing gestational age for use, permitting mail delivery of the medication, and allowing non-physicians to prescribe it.
The Supreme Court declined to review a reinstatement request from anti-abortion plaintiffs for a total ban on mifepristone.
This case gives the Supreme Court an opportunity to weigh in on abortion issues and could impact the biopharma industry and the authority of the Food and Drug Administration (FDA). The antiabortion group behind the challenge argues that the FDA didn’t adequately consider safety concerns during the drug’s approval process.
Potential outcomes of the case
If the Supreme Court upholds the entirety of the Fifth Circuit’s decision, it would be a victory for the Alliance Defending Freedom, the group representing the anti-abortion providers. This could revert mifepristone regulations to 2015 standards, making the drug harder to obtain and striking a significant blow to the FDA’s authority.
Manufacturers would have to change the drug’s label, and the FDA would need to revise its rules and regulations for distribution and use, delaying the drug’s marketing until it’s relabeled.
If the justices reverse the Fifth Circuit’s decision, it would be a win for the White House, Danco Laboratories, and abortion rights advocates. This would maintain the status quo, leaving mifepristone on the market without changes. Anti-abortion groups would perceive this as a significant defeat.
A third possibility is the justices could uphold some post-2016 changes but invalidate others. If mifepristone access is restricted, abortion providers note that pregnancies could still be terminated using misoprostol, the second drug in the regimen, although it has more side effects and is less effective.