FDA argues public harm if court reverses abortion pill approval

A lawsuit challenging the decades-old Food and Drug Administration (FDA) approval of mifepristone has no merit, and a Texas judge should reject a request for a court order revoking that approval, the Biden administration argued in a Tuesday filing.   

The FDA said granting the request from anti-abortion groups would be “unprecedented.”

“The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for twenty-two years,” it argued.

The lawsuit was filed in November in Amarillo, Texas, by the Alliance Defending Freedom (ADF), a conservative legal group that has helped author states’ anti-abortion laws and defended Mississippi in the case that led the Supreme Court to overturn the abortion protections granted in Roe v. Wade. 

The case was assigned to District Judge Matthew Kacsmaryk. Prior to being appointed by former President Trump in 2017, Kacsmaryk was deputy general counsel at the First Liberty Institute, a Christian legal advocacy group.

The lawsuit argues the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for treatments of life-threatening illnesses. The group alleges the agency failed to protect the health, safety and welfare of girls and women and never studied the safety of the drugs under the labeled conditions of use.

The lawsuit “is the culmination of decades-long efforts by ADF’s clients to hold the FDA accountable for its irresponsible actions,” the group said.  

The lawsuit asks for the court to immediately pause the FDA’s approval of the drug while the case proceeds, which would effectively make all medication abortions illegal.

In the filing, Biden administration attorneys said the plaintiffs face no injury, let alone any irreparable harm.

“Yet they ask this Court for emergency relief in the form of a mandatory injunction that would immediately withdraw approval of a safe and effective drug that has been available in the United States for more than two decades—based on speculative allegations of harm and Plaintiffs’ untested assertions … that they know better than FDA whether this drug is safe,” the administration said. 

Mifepristone, a drug that blocks hormones necessary for pregnancy, was approved by the FDA in 2000 to induce an abortion up to 10 weeks into a pregnancy. It must be followed by a second drug, misoprostol. 

Since the Supreme Court’s decision overturning Roe v. Wade in June, women have increasingly turned to abortion pills if they need to terminate a pregnancy.

Health officials and major groups such as the American Medical Association and the American College of Obstetricians and Gynecologists say mifepristone is safe and effective.

Mifepristone has been used by more than 3 million people in the United States since its FDA approval, the groups said in a June letter to the Biden administration, “and robust evidence exists regarding the safety of mifepristone for medication induced abortion.”

In the filing, the FDA said the pill was approved in part because it provides a “meaningful therapeutic benefit” to some patients over surgical abortion. Revoking the approval would force patients to undergo unnecessary and more invasive surgical abortions in many cases, the agency argued.