Biotech
Wednesday, August 16th, 2023 3:00 pm EDT
A federal appeals court ruled on Wednesday to limit access to the widely used abortion pill mifepristone, but disagreed with a lower court decision that had ordered the drug off the market.
The opinion, issued by a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit, would reverse steps taken by the Food and Drug Administration since 2016 that allow the pill to be ordered online and dispensed by mail.
However, the circuit court’s ruling won’t take immediate effect under an order issued by the Supreme Court in late April that keeps the status quo until the appeals process is complete.
In a statement, White House Press Secretary Karine Jean-Pierre said the Department of Justice will ask the Supreme Court to review the decision. The Biden administration “strongly disagree[s]” with the ruling, she said, adding that it “undermines FDA’s scientific, independent judgment and reimposes onerous restrictions on access to safe and effective medication abortion.”
The FDA approved mifepristone, which is also sold under the brand name Mifeprex, in 2000. Along with another drug called misoprostol, it’s used in about half of all abortions in the U.S. Testing, and years of use, have shown mifepristone to be broadly safe and effective for terminating pregnancy.
Over that time, the regulator has loosened guidelines for the drug, allowing the pill to be used through 10 weeks gestation and prescribed by pharmacists. Most notably, in 2021, it stopped enforcing a requirement the drug be administered in person, enabling mifepristone prescriptions to be sent via mail. The agency later formally changed its policy.
Last year, the Alliance for Hippocratic Medicine — a group working on behalf of conservative doctors and anti-abortion groups — challenged the FDA’s original 2000 approval of mifepristone and its subsequent actions, suing the agency in federal court in Texas. The judge there, Matthew Kacsmaryk, ruled in mid-April to suspend the drug’s approval. His decision was swiftly appealed by the Biden administration.
After the 5th Circuit partially blocked Kacsmaryk’s order, the Supreme Court issued an emergency stay that kept the current rules in place and returned the case back down to the appeals court.
The 5th Circuit’s three-judge panel has now overruled Kacsmaryk’s suspension of mifepristone’s original approval, determining the Alliance was too late to challenge the 23-year old FDA decision. But it agreed with his decision to stay the more recent changes to prescribing rules.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time,” the judges wrote.
One of the three, Circuit Judge James C. Ho, went further, arguing in a partially dissenting opinion that the way the FDA approved mifepristone was “unlawful.”
According to the American Medical Association, restricted access to legal and safe abortion is associated with higher maternal morbidity and mortality rates.
“Reduced access to mifepristone will almost certainly exacerbate the maternal mortality crisis in places that do not have access to this medication,” the AMA said in a statement on the circuit court’s decision. A number of states have banned abortion following last year’s Supreme Court ruling that overturned Roe v. Wade and its protections for the procedure.
The case, and its threat to the availability of a drug two decades on the market, have also raised alarms within the biotechnology industry. Drugmaker leaders have warned revoking mifepristone’s clearance will undermine the FDA and create a precedent by which other groups could challenge other medicines’ approvals.
In his dissent, Ho pushed back on criticism of judicial overreach. “The scientists at the FDA deserve our respect and our gratitude, but not our blind deference,” he wrote. “That would defy Congress’s clear directive that courts conduct independent legal review of FDA action under the [Administrative Procedure Act].”
Editor’s note: This story has been updated with statements from the White House and the American Medical Association.
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