US judge suspends regulatory approval of abortion drug

A federal judge in Texas has ordered the US Food and Drug Administration to withdraw its approval of a popular abortion pill in a move that, if upheld, would amount to a nationwide restriction on the drug.

District judge Matthew Kacsmaryk ordered a preliminary injunction of the drug mifepristone, one of two drugs used to end pregnancies, which would affect access to it even in states with abortion protections.

However, the ban ordered by the Donald Trump-appointed judge will take effect in seven days, allowing the Biden administration time to appeal against the decision. Attorney-general Merrick Garland said he “strongly disagrees” with the decision and would appeal.

The ruling was also contradicted by a separate court decision in Washington state, which ordered the FDA to continue to supply mifepristone. The issue could eventually reach the US Supreme Court.

The unprecedented ruling against a drug which has held approval for more than two decades is one of the most consequential abortion-related decisions since the Supreme Court last summer overturned the Roe vs Wade ruling that protected women’s constitutional right to abortion.

The overturning of Roe was a significant victory for US anti-abortion advocates, who have crusaded against Roe for decades. Abortion-rights supporters, meanwhile, feared it would result in widespread bans on the procedure in many Republican-led states.

The Texas ruling is a result of a November filing by a collection of anti-abortion groups who alleged that the FDA did not properly approve the drug for terminating pregnancies, and had not considered its safety when used by girls under the age of 18.

Big medical organisations, including the American College of Obstetricians and Gynecologists, have supported the FDA, arguing that mifepristone “has been thoroughly studied and is conclusively safe”.

The decision was quickly criticised by Democratic lawmakers, including Senator Elizabeth Warren, who branded Kacsmaryk “an extremist Republican judge” and called on US attorney-general Merrick Garland to “quickly appeal this decision”.

“Today’s decision blatantly disregards decades of medical research for politically motivated reasons that will jeopardise the health of millions of people nationwide,” said New York attorney-general Letitia James. “Restricting access to safe and effective medication is a dangerous attack on reproductive freedom, public health, and scientific integrity.”

In the aftermath of the Supreme Court’s Roe ruling, President Joe Biden called for Congress to codify abortion rights into federal law, and said the federal government would seek to protect Americans’ rights to travel across state lines to seek them in states that still allowed them.

The opposing ruling in Washington state followed a lawsuit filed by a group of Democratic attorneys-general who sought to “affirm FDA’s original conclusion that mifepristone is safe and effective”.

Justice Thomas Rice granted a preliminary injunction prohibiting the FDA from taking any action that would reduce the availability of mifepristone.