Latest Update January 30, 2024

GenBioPro submits amicus brief to Supreme Court

The brief argues that the Fifth Circuit Court of Appeal’s order restricting access to medication abortion was wrong, and urges the Supreme Court to reverse the Fifth Circuit's ruling.

Our Statement

Far-right, anti-science activists in Texas brought a lawsuit to block access to medication abortion in states across the country. 

More than 20 years ago, the U.S. Food and Drug Administration (FDA) approved mifepristone as safe and effective medication. This lawsuit—filed by anti-science activists in Texas against the FDA and the U.S. Health and Human Services (HHS) in November 2022—challenges the FDA’s initial approval of mifepristone as well as its more recent actions to increase access to the medication.

This case, AHM v. FDA, is a dangerous and severely disruptive departure from the norm of reasoned and science-based agency decision-making regarding drug approvals. It not only threatens the health of Americans across the country, it also undermines our democratic values. 

Last spring, a Texas district court issued a ruling blocking access to this medication in states across the country — a decision that had no basis in law or fact, and the U.S. Court of Appeals for the Fifth Circuit largely refused a request for stay of that decision.

Manufacturer of generic mifepristone, GenBioPro, urged the Supreme Court to reject efforts to turn back the clock on access to the medication. 

GenBioPro has held an FDA approval for generic mifepristone since 2019 and currently manufactures an estimated two-thirds of the mifepristone sold in the United States. Since its founding, GenBioPro has sought to make mifepristone more affordable and accessible for people, regardless of income, gender, race, or geography. 

Consistent with that commitment, in April, following an emergency petitions to the Supreme Court filed by the federal government and the company that has held the  initial approval for mifepristone since 2000, we, on behalf of GenBioPro, submitted an amicus brief in support of a stay in AHM v. FDA. The Supreme Court issued that stay in April 2023.

The case was then kicked back to the Fifth Circuit Court of Appeals which, on August 16, ruled that recent FDA actions with respect to mifepristone were illegal, and ordered the return to burdensome pre-2016 restrictions on mifepristone. That ruling, however, has not gone into effect because of the previous order by the Supreme Court to pause any changes to limits on the medication’s availability.

The Biden administration then appealed to the Supreme Court. 

On October 12, we filed an amicus brief at the Supreme Court on behalf of GenBioPro urging the Court to review the Fifth Circuit’s ruling. 

The brief, which outlines the “severe” real-world consequences of the Fifth Circuit’s decision, highlights the specific impact on GenBioPro and the larger healthcare community if that decision is allowed to take effect. 

The brief underscores the impact of the Fifth Circuit’s decision on GenBioPro’s ability to market mifepristone and on patients seeking that medication. The brief further highlights how GenBioPro’s customers and partners would be faced with uncertainty about whether and how they can distribute and use mifepristone already circulating in the marketplace. 

On December 13, 2023, the Supreme Court granted cert, agreeing to review the Fifth Circuit’s decision. 

That decision by the Supreme Court to review the Fifth Circuit’s ruling does not disturb the approval of generic mifepristone, and the medication remains lawful and available based on the prior stay the Supreme Court issued.

We will continue to use legal and regulatory tools to protect access to mifepristone and will oppose attempts to improperly use the courts to attack science and evidence.

On January 30, 2024, GenBioPro filed an amicus brief urging the Supreme Court to reject the Fifth Circuit’s decision.