Access to abortion pills at risk in US as judge weighs ‘unprecedented’ case

A lawsuit challenging US regulators’ approval of the abortion pill two decades ago has threatened to plunge the industry into chaos and further undermine women’s access to reproductive healthcare, pharmaceutical executives and legal experts have warned.

Anti-abortion groups including the Alliance for Hippocratic Medicine have asked a federal court in Amarillo, Texas, to rescind a decision by the US Food and Drug Administration in 2000 to green light mifepristone, arguing the agency did not properly study the drug’s safety and exceeded its authority in approving it in the first place.

The case is being heard by Judge Matthew Kacsmaryk, who was appointed by former president Donald Trump and has a history of issuing conservative rulings on reproductive health and social issues such as gay rights.

Kacsmaryk is expected to soon decide whether to grant the plaintiffs’ request for a sweeping injunction that could ban nationwide distribution of the drug. That prospect has raised concern within industry, Joe Biden’s administration and women’s rights groups about the far-reaching consequences of such a decision.

Mifepristone is a crucial ingredient in abortion pills, which account for more than half of all pregnancy terminations in the US and have become the latest battleground for abortion rights since the Supreme Court last year overturned its nearly 50-year-old decision in Roe vs Wade.

Jeremy Levin, a member of the board and chair emeritus of Bio, a biotech industry lobby group, said an injunction would have grave consequences for women, who would struggle to access abortion care or get access to mifepristone to treat miscarriages.

A ruling in favour of the anti-abortion groups would take “a legal sledgehammer” to the independent system of medical and scientific appraisal of drugs established by the FDA, he added, in addition to creating regulatory “chaos” and raising costs for industry.

“The precedent would be deeply unsettling and raises the question . . . what could be next tomorrow? It opens the door for potential political or religious third parties to question and overturn the determinations of our nation’s drug regulatory and safety system,” Levin said.

The FDA has warned in court filings that the plaintiffs’ demand for a preliminary injunction on distribution of mifepristone is “unprecedented”, relies on “speculative allegations” without any merit and, if granted, would entangle the agency in litigation over virtually any of its actions.

The Texas case is the latest move in a campaign waged by anti-abortion activists aimed at restricting abortion access since the Supreme Court decided to leave the matter up to individual states. Several Republican-led states have banned abortion since that ruling, while others have already passed laws banning abortion pills. In response, the Biden administration has expanded access to some abortion services and supported patients’ right to travel out-of-state to terminate a pregnancy.

One unique feature of the abortion pill case is that it aims to allow one judge in Texas to restrict access to the procedure across the country, including states where it would otherwise be legal, such as New York, Illinois and California, according to Carrie Flaxman, senior director for public policy litigation at Planned Parenthood.

The parties bringing the Texas lawsuit — four anti-abortion groups including the Alliance for Hippocratic Medicine and four doctors — say such a sweeping ruling is necessary, alleging the FDA chose “politics over science” when it pushed for mifepristone abortion drugs in 2000. It claims the agency exceeded its authority by using a fast-track process to approve the drug and did not properly evaluate the safety of the drug under the labelling conditions of use.

The lawsuit claims the drug is “dangerous”, despite evidence showing abortion pills are safe with low levels of complications.

Erik Baptist, senior counsel for the Alliance Defending Freedom, an anti-abortion group, denies the groups’ demand for an injunction to prevent abortion pill sales would undermine the FDA approval mechanism, describing it as a unique case.

“We are not aware that this would set a precedent because the FDA’s actions over this course of this particular drug regimen have been so unprecedented and so reckless.”

Many legal scholars disagree. They warn the case is the latest example of anti-abortion groups using a legal tactic called “forum shopping” to file lawsuits with little legal merit in jurisdictions where judges are likely to be sympathetic to their arguments. Kacsmaryk is the only district judge who sits regularly in the Amarillo division of the Texas federal court where the case was filed.

“This case is meritless but the plaintiffs have forum-shopped a judge that is very sympathetic to their anti-abortion views so there is a lot of fear that the plaintiffs could prevail,” said Greer Donley, director of the degree programme of law and bioethics at University of Pittsburgh.

She said Kacsmaryk had shown his own biases in reproductive healthcare cases, including a ruling that parents have the right to prevent their children from accessing birth control.

Donley is one of 19 legal scholars who filed an amicus brief in the case arguing the plaintiffs’ demand for an injunction on mifepristone lacked merit. The proposed remedy would undermine the regulatory framework for drug approvals and cause harm to patients, healthcare providers and the pharmaceutical industry, the scholars argued.

Susan Lee, a partner at the law firm Goodwin who specialises in life sciences regulation, said Kacsmaryk had several options when issuing his ruling. He could declare the approval of mifepristone invalid and grant an immediate injunction — a dramatic and unprecedented outcome that would almost immediately be appealed. He could also offer a partial victory to anti-abortion groups by banning pills delivered by mail and ordering that in-person visits resume, she said. Or he could simply dismiss the case.

Lee said the case raised questions about the role of the judiciary in such controversial issues.

“One of the fundamental presumptions of the US judiciary is that judges are there to interpret the law, not necessarily to fundamentally move the law in dramatic directions,” she said.