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US abortion pill duel intensifies

Less than a year after the US Supreme Court declared it was ceding the matter of abortion to elected officials, judges are about to consider whether the most common method of ending pregnancies can be prohibited in states where abortion remains legal, not just where it is illegal.

After a federal appeals court imposed several access barriers to the commonly used abortion pill mifepristone last Wednesday, the Justice Department announced the very next day that it would seek emergency relief from the judges, asking them to block the ruling while a fast-tracked appeal moved forward, reports The New York Times.

The appellate ruling, from a divided three-judge panel of the US Court of Appeals in New Orleans, said the pill, mifepristone, could remain available while the lawsuit, filed against the US Food and Drug Administration (FDA) by anti-abortion groups, proceeded through the courts.

In its order, the panel partly rejected a ruling from Judge Matthew Kacsmaryk of Texas, who declared last week that the FDA’s approval of mifepristone in 2000 was not valid … in essence, that the drug should be pulled from the market.

The panel blocked various steps taken by the FDA in recent years to ease access to the drug, including allowing it to be sent through the mail and prescribed by health care providers who are not doctors.

The appellate court said its ruling would hold until the full case was heard on its merits.

However, last Thursday, a federal judge in another mifepristone lawsuit issued an order that required the FDA not to limit access to the drug in much of the country.

That lawsuit, filed by Attorneys-General in 17 states and the District of Columbia, challenged extra restrictions the FDA imposes on mifepristone.

On Friday, Judge Thomas Rice of Washington blocked the agency from curbing the availability of mifepristone in those states. He reaffirmed that order said that it “must be followed” by the FDA “irrespective” of what the Fifth Circuit appeals court would do.

Legal experts said the duelling federal court orders could make it more likely that the Supreme Court will need to resolve the status of the abortion pill.

When the Supreme Court eliminated the constitutional right to abortion in June, overturning a half-century of precedents, it made a vow. Writing for the majority in Dobbs v Jackson Women’s Health Organisation, Justice Samuel Alito Jr said that “the authority to regulate abortion must be returned to the people and their elected representatives”.

Hundreds of pharmaceutical industry leaders and investors have slammed the ruling invalidating mifepristone’s approval and filed a brief supporting the FDA in the case.

“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,” they wrote in a statement on Monday. Leaving the fate of medicines in the hands of jurists, they argued, would have a chilling effect on drug development in the United States, reducing incentives for investment and innovation.

In its order, the appellate panel said the FDA’s approval of mifepristone could stand because too much time had passed for the plaintiffs, a consortium of groups and doctors opposed to abortion, to challenge that decision. The court also seemed consider the government’s view that removing a long-approved drug from the market would have “significant public consequences”.

But the appellate court said that it was not too late for the plaintiffs to challenge a set of steps the FDA took, beginning in 2016, that lifted restrictions and made it easier for more patients to have access to the pill.

The court also said that the government could not logically claim that the changes made since 2016 were crucial to the public, “given that the nation operated, and mifepristone was administered to millions of women, without them for 16 years” after the initial pill approval.

The ruling would reinstate measures that required mifepristone to be prescribed and dispensed only by a doctor and picked up in person by the patient, who would have to visit the doctor three times during the medication abortion process.

Changes since 2016 also included the FDA’s approval in 2019 of a generic version of mifepristone, manufactured by GenBioPro, whose product is now used by many telemedicine abortion services and clinics.

Kacsmaryk, a who has written critically of the Roe v Wade decision, had stayed his order for seven days to give the FDA time to appeal.

In their lawsuit, the abortion opponents claim that mifepristone is unsafe, causing “cramping, heavy bleeding and severe pain”, and that the FDA has ignored safety risks and never adequately evaluated the scientific evidence.

The FDA vigorously disputes this claim, as do mainstream medical organisations. They say that bleeding and cramping are normal consequences of the process, a sign that the pregnancy tissue is being expelled, and cite years of scientific studies that show that serious complications are rare, resulting in less than 1% of patients needing hospitalisation.

 

The New York Times article – Abortion Is Back at Supreme Court’s Door After Dueling Orders on Pill (Restricted access)

 

See more from MedicalBrief archives:

 

Canada’s benign experience with normally prescribed abortion pill mifepristone

 

Big Pharma slams US abortion pill ruling

 

US AGs weigh in on court battle over access to abortion medicines

 

 

 

 

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