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.
“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.
This story originally appeared on: Financial Times - Author:Jamie Smyth
