Doctor Groups Ask Supreme Court to Undo FDA Abortion Drug Approval

The U.S. Supreme Court in Washington on June 30, 2023. Kevin Dietsch/Getty Images

Several doctors’ groups have filed court papers with the U.S. Supreme Court that ask the justices to strike down the U.S. Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone.

The Alliance for Hippocratic Medicine and other physician groups stated in a Supreme Court petition last week that the health agency approved the drug under a process that was designed for drugs meant to treat illnesses. They said pregnancy is a “natural process that many women experience,” and not an illness.

The Louisiana-based U.S. Court of Appeals for the 5th Circuit in August ruled that the FDA has to restore safeguards for chemical abortion drugs and not allow them to be shipped by mail across the United States. The Department of Justice and the drug maker, Danco, filed petitions with the Supreme Court and asked the justices to hear their case.

“The FDA’s recent actions on chemical abortion drugs have harmed the health of countless women and girls and undermined the rule of law by illegally removing every meaningful safeguard from the chemical abortion drug regimen,” the Alliance said in a statement.

“The FDA’s unprecedented actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health. We are urging the Supreme Court to deny the Biden administration’s request to overrule the decision of” the Louisiana-based U.S. Fifth Circuit Court of Appeals,” it stated.

The 5th Circuit’s ruling prohibited the mailing of chemical abortion drugs through the mail, which the FDA has allowed since 2021.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the court wrote. “It failed to consider the cumulative effect of removing several important safeguards at the same time.

The federal drug regulator also “failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events,” the ruling said. “And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

Mifepristone tablets are displayed in Rockville, Md., on April 13, 2023. Anna Moneymaker/Getty Images

Earlier this year, the Supreme Court granted a request from the Justice Department to leave in place the FDA’s approval of the abortion drug. At the time, Justice Clarence Thomas said he would have denied the emergency petition, while Justice Samuel Alito dissented.

“The Fifth Circuit countermanded a scientific judgment FDA has maintained across multiple administrations; imposed unnecessary restrictions on the distribution of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies,” the Justice Department wrote to the court.

The petition added that the ruling “has especially disruptive implications for the pharmaceutical industry and those who depend upon the drugs it supplies.”

This month, multiple other medical groups submitted amicus briefs to the Supreme Court and argued the need for the court to review the 5th Circuit’s order.

“The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting the industry’s reasonable investment-backed expectations. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards,” the Pharmaceutical Research and Manufacturers of America wrote in a brief.

According to health officials, mifepristone blocks the hormone progesterone that is needed for a pregnancy to continue. When used with another drug called misoprostol, the pill is used to end a pregnancy through 10 weeks.