WASHINGTON (CN) — The Supreme Court intervened Friday to ensure that medication abortion remains available to the public without restrictions while a legal battle plays out in the lower courts.
In separate orders this afternoon — one for the Food and Drug Administration and another for Danco Laboratories, which makes the drug mifepristone — Justice Samuel Alito stayed last week's injunction from U.S. District Judge Matthew Kacsmaryk that would have taken the popular abortion drug off the market.
Alito's stays will be in place until Wednesday as he and the rest of the court consider additional briefing in the case.
The Biden administration and Danco Laboratories lobbied for the emergency intervention just this morning, claiming Kacsmaryk's ruling would cause broad harm.
“If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority,” U.S. Solicitor General Elizabeth Prelogar wrote.
The challenge to mifepristone hinges on its FDA approval two decades ago. A group of anti-abortion doctors claim the drug is unsafe, even though its risk of death is 10 times less than that of the erectile dysfunction drug Viagra and four times less than penicillin.
Regulators initially fought Judge Kacsmaryk's injunction at the Fifth Circuit, which considers appeals out of Texas and a few other neighboring states. In a split decision, the federal appeals court said mifepristone could stay on the shelves but only with some restrictions to the drug’s prescription and distribution. The appeals court ruling would have required abortion seekers to schedule three doctors visits to be prescribed mifepristone — as opposed to one telehealth visit — and the drug would have to be administered in a doctor’s office, not via the mail.
That would necessitate the relabeling of any mifepristone currently on the market, the government claims, a move that could take months. Additionally, the generic version of the drug would be completely unavailable under the Fifth Circuit's ruling.
GenBioPro, which makes mifepristone’s generic version, also complained about the harm it would face.
“That result makes no sense; it is clear and obvious legal error; and it is already wreaking havoc for GenBioPro, throwing the marketplace into disarray, and creating massive confusion in the public health communities that depend on its product and the thousands of people who will be denied the safe and effective treatment GenBioPro’s product provides,” John Elwood, an attorney with Arnold & Porter, wrote in an amicus brief.
Pill abortions account for over half of all abortions nationwide, and GenBioPro supplies two-thirds of the drug used domestically for the procedure.
Over two dozen states told the justices that mifepristone is critical to their goal of protecting their residents' health and safety. The states also say the Texas ruling would violate their sovereignty.
“Although this Court concluded that the U.S. Constitution does not protect the right to obtain an abortion, it emphatically endorsed the States’ authority to safeguard access to abortion for their residents, explaining that it was ‘return[ing] the issue of abortion to the people’s elected representatives,’” New York Solicitor General Barbara Underwood wrote in the state’s brief. “The lower courts’ rulings could eviscerate the sovereign decisions of many amici States by disrupting access to mifepristone in States where abortion is lawful.”
Drug companies claim revoking mifepristone’s approval would have broad consequences for other drugs on the market.
“Far from being limited to one drug, the logic of the decisions below could upend FDA’s drug-approval process and empower any plaintiff to challenge the approval of other drugs, regardless of how long the drug has been on the market, on spurious grounds,” wrote King & Spalding attorney Eva Temkin, representing the pharmaceutical companies and investors.
The Alliance for Defending Freedom, which represents the doctors, did not respond to a request for comment.
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