Ironically, or fittingly, depending on the observer’s viewpoint, both of the US cases – brought by anti-abortion groups on the religious right – were decided on “Good Friday “, Apr. 5, which is not a holiday in the US.

The decision in Texas by US district judge Matthew J. Kacsmaryk, a nominee of former president Donald Trump known for opposing all types of abortion, would rescind the US Food and Drug Administration’s year 2000 approval of mifepristone.

In the second case, involving a similar lawsuit, a federal court in Washington state allowed the drug to be distributed solely in states that permit medication abortions.

The Texas decision has received an enormous backlash, from President Joe Biden, the US Department of Health and Human Services (HHS) and the Department of Justice down to companies in the medical and pharmaceutical sector and women’s rights advocates.

Biden said the court had “substituted its judgment for the FDA’s.” “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA that would be safe from these kinds of political, ideological attacks.”

Without appeal, mifepristone would be banned

If this ruling – the first-ever suspension of the FDA‘s approval of a medication despite opposition from the agency and the drug’s manufacturer – is not successfully appealed to a higher instance by Apr. 12, mifepristone could no longer be sold in the United States.

The repercussions would not be limited to this one drug, as the judge has questioned the FDA’s right to approve certain controversial medicines, a situation that worries manufacturers.

Attorney General Merrick Garland said the government would ask the US Court of Appeals for the 5^th Circuit in New Orleans, which has jurisdiction for the region, to allow the FDA to maintain approval of the pill pending the outcome of the case.

Some commentators suggest that the Biden administration may take the Texas case to the Supreme Court before New Orleans rules, as this court has a history of favoring conservative causes.

In his remarks, HHS Secretary Xavier Becerra told US media, “we don’t believe it is in anyone’s interest to have the sound, tested, proven approval process that FDA goes through before it lets any drug on the market be overturned.”

Especially disturbing to drugmakers as well as to the US government is Kacsmaryk’s accusation that the FDA ignored “legitimate safety concerns” in approving mifepristone, basing its approval on “plainly unsound reasoning and studies that did not support its conclusions” adding that the agency had faced “significant political pressure” to increase access to chemical abortion.

Pharma industry writes open letter

In an open letter, more than 400 executives of pharma and biotech companies, including Pfizer – none of which make mifepristone – as well as private equity groups investing in the industry condemned the Texas ruling.

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” the authors said.

Medication-induced abortion has become increasingly contentious since the Supreme Court’s right-leaning majority in June 2022 overturned the nearly 50-year-old Roe v. Wade ruling handed down by an earlier, liberal iteration of the court.

Last June’s ruling replaced a constitutional right to abortion nationwide and allowed individual states to outlaw or sharply restrict the procedure.

Since then, many conservative states have passed laws that criminalize the procedure and have taken aim at clinics performing abortions. Now they before turning their attention to companies making pills that can be used to terminate pregnancies at home.

Author: Dede Williams, Freelance Journalist