US Justice Department appeals Texas court ruling which would halt approval of major abortion drug | US News

The US Justice Department is appealing a Texas court ruling which would halt approval of the drug used in the most common method of abortion in the country.

In its appeal the Biden administration said the “extraordinary and unprecedented” ruling in Texas last week should remain on hold while it challenges the decision.

The order issued by US District Judge Matthew Kacsmaryk, an appointee of Donald Trump, could restrict access to the abortion medication mifepristone in the United States as early as Friday.

Mr Kacsmaryk signed an injunction directing the Food and Drug Administration (FDA) to halt its approval of the drug while a lawsuit challenging its safety continues.

The drug, which blocks the hormone needed to maintain a pregnancy, has been widely used in the US since its approval by the FDA in 2000.

It is used safely in more than 60 countries worldwide and when taken together with the drug misoprostol, accounts for more than half of abortions in the US.

Now, with mifepristone access in jeopardy, pro-choice campaigners fear that getting an abortion in the US has become even harder to navigate.

There is essentially no precedent for a lone judge overruling the FDA’s medical decisions, and pharmaceutical executives signed a letter on Monday warning that the ruling could endanger other medications.

The US Justice Department said in its statement: “If allowed to take effect, the (Texas) court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”

Mr Kacsmaryk issued his decision Friday but ruled it would not take effect for seven days – meaning the end of this week barring another court stepping in.

A conflicting order by a different federal judge in the state of Washington has added to uncertainty and confusion.

A judge in Washington said the FDA must keep medication abortion drugs available in at least 12 liberal states, creating a legal stand-off on the drug, which is likely to escalate to the Supreme Court.

Underlining that confusion, the US Justice Department on Monday separately asked the federal court in Washington state for clarity, given the competing orders.

Meanwhile, many abortion providers must wait and see what happens in the courts between now and Friday before deciding what to do next, Jennifer Dalven, director of the American Civil Liberties Union’s Reproductive Freedom Project, told reporters.

If the Texas court’s ruling takes effect, some providers are prepared to pivot to a misoprostol-only regimen while others may transition to only surgical abortions.

“We don’t know exactly what will happen,” Ms Dalven said. “What we do know is that there will be significant confusion and chaos as providers try to provide the best care they possibly can for their patients.”

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The lawsuit in Texas was filed by the Alliance Defending Freedom, a conservative Christian group which was also involved in the Mississippi case that led to Roe v. Wade being overturned.

Roe v Wade refers to the 1973 Supreme Court case that said the government could not prohibit abortions because the constitutional right to liberty includes the right to decide whether to continue a pregnancy.

At the Texas lawsuit’s core is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.

Courts have long deferred to the FDA on issues of drug safety and effectiveness.

But the agency’s authority faces challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.

In a statement after the Texas ruling, President Joe Biden said: “My administration will fight this ruling…

“Let’s be clear – the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe versus Wade.

“Vice President [Kamala] Harris and I will continue to lead the fight to protect a woman’s right to an abortion, and to make her own decisions about her own health.”