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(CNN) The Supreme Court on Friday protected access to the widely used abortion drug by freezing a lower court ruling that imposed restrictions on its use as appeals unfolded.
As a result, the U.S. Food and Drug Administration’s approval of the drug mifepristone and subsequent actions to make it more readily accessible will remain in place while the appeals are filed. Probably in the next few months.
Friday night’s move was an impressive win for the Biden administration and its supporters in the abortion rights community, setting a Roe v. Wade precedent last year in which a conservative majority defended abortion rights nationwide on the Supreme Court. suffered a withering defeat when overturned.
The court’s unsigned succinct order did not explain why it granted the Biden administration and the drug manufacturers’ request to intervene. Justices Clarence Thomas and Samuel Alito publicly dissented. The other judges’ votes were not disclosed.
The case is the most important abortion-related dispute to come to the Supreme Court since a judge overturned Roe v. Wade, prompting conservative states across the country to ban or severely limit the procedure. How the controversy over medical abortion is ultimately resolved could make it more difficult for women to get an abortion.
At issue is the extent of the FDA’s authority to regulate mifepristone, which the medical community considers safe and effective. Over her 20 years on the market, Mifepristone has been used by millions of women across the country.
The next step in the lawsuit is a hearing at the New Orleans-based Federal Court of Appeals on May 17.
“Once the Fifth Circuit decides, the case may return to the judges, but unless the court takes the case on both the merits and on the part of the dissenters, what will happen to access to mifepristone? It’s no different,” said Steve Vladeck. CNN Supreme Court analyst and professor at the University of Texas Law School. “It won’t happen for long – if at all.”
President Joe Biden applauded the order.
“As a result of the Supreme Court suspension, mifepristone remains available, approved for safe and effective use, and this battle continues in court,” Biden said in a statement Friday evening. .
Biden also urged the American people to “use their votes as their voice to elect a Congress that passes legislation to restore Roe v. Wade’s protections.”
Attorneys for the Physicians Group that filed the complaint downplayed the order.Erik Baptist, an attorney for Alliance Defending Freedom, said in a statement, “As is common practice, the Supreme Court has decided to maintain the status quo.
“Our case, which seeks to put women’s health ahead of politics, is progressing swiftly in the lower courts,” Baptiste added. I am doing it.”
Alito suggests government may have ignored mifepristone ban
Dissenter Alito said he voted to deny the stay request because the Fifth Circuit Court of Appeals is scheduled for an expedited hearing on the merits of the dispute.
He suggested that leaving the restrictions in place would not “actually cause harm in the short period of time that appears to be in question.”
Alito said the suspension did not “take mifepristone off the market,” but rather that it was a new drug introduced by the FDA in 2016 to make the pill easier to access since mifepristone was approved in 2000. It wrote that it was only restoring the “existing situation” before the regulation was passed. .
“The government has not dispelled legitimate suspicions that it would even comply with adverse orders in these cases, much less choose to take enforcement actions it strongly disagrees with,” Alito wrote.
No other judge joined his dissent.
Abortion drug advocates react
Danko Laboratories, the drug manufacturer that stepped in the case to defend the approval of mifepristone, said Friday to maintain “critical access to the drug that millions of patients depend on.” welcomed the order of
Danko’s attorney, Jessica Ellsworth, said, “Long-standing revocation of FDA approvals by lower courts has caused widespread confusion among providers, patients and the healthcare system. It provides continuity for all parties involved when litigating an issue in the United States.” statement.
The drug’s other manufacturer, GenBioPro, did not intervene in the lawsuit, but FDA approval of their product (a generic version of the abortion drug) would be suspended if the Supreme Court allowed the lower court’s ruling to remain in effect. It must have been done.
“With today’s Supreme Court ruling, mifepristone is legal and available,” the company’s CEO Evan Masingill said in a statement to the order Friday night. “GenBioPro will continue to serve customers.” and are committed to providing evidence-based essential medicines to everyone who needs them.”
U.S. Department of Health and Human Services Secretary Xavier Becerra said the order was “an important step in the right direction.” Prescription drugs. ”
“We are confident the law is on our side and remain focused on winning the case in court,” he said. The Justice Department declined to comment.
Lower court ruling second-guessed FDA’s valuation
The legal battle began last November with a lawsuit filed by a group representing doctors who oppose abortion, alleging that the FDA did not do enough to make the drug safe nearly two decades ago. I got
President Trump-appointed U.S. District Judge Matthew Kaksmalik issued a broad ruling on April 7 blocking approval of the drug, and in the years that followed, the FDA sought to make the drug more accessible. He made changes. However, he delayed the effective date of the ruling by seven days to give him time to appeal.
Rejecting the medical community’s consensus, Kaksmalik questioned the drug’s safety, emphasizing his views in jargon commonly used by abortion opponents. , explained that it rejected the term “fetal” in favor of the more inflammatory “fetal” term. Instead of calling the procedure a “medicinal abortion,” he insisted on calling it a “chemical abortion.”
FDA’s Kacsmaryk argued that at one point, “they violated their statutory obligations and acquiesced to legitimate safety concerns.”
Mainstream medical associations have condemned his claims about the drug’s dangers, and mifepristone has been shown to be safer than common medications such as penicillin and Viagra.
On the question of the key breaking point, the judge argued that the plaintiffs (physicians who did not use or prescribe the drug) could be “overwhelmed” by the use of the drug. , claimed it had a legal right to sue. medical system.
Shocked by the breadth of the ruling, the Biden administration and Danko, the drug’s manufacturer, appealed to the Fifth Circuit Court of Appeals.
The appeals court ultimately upheld government approval of the drug, but agreed with Kaksmalik’s opinion that access could be restricted.
A split panel of three judges ordered a return to the stricter pre-2016 FDA regime for drugs. This made it impossible to mail pills to patients who obtained them through telemedicine or conduct virtual visits with providers instead of going to a clinic or hospital. Get medicine directly. It would also effectively cancel the 2019 approval of generic drugs. This restriction also affects the instructions on the drug’s label, shortening the period during which the pill can be obtained from 10 weeks pregnant to her 7 weeks.
But even if the ruling goes into effect, some providers may go “off label” and continue to prescribe mifepristone for up to 10 weeks.
The Fifth Circuit Court of Appeals ruled that the FDA’s rule on this drug created a “very abnormal system” and that anti-abortion physicians were “necessarily harmed by the consequences” of the FDA’s decision, so they had no right to sue it. claimed to be. Exclude your doctor from prescribing and administering Mifepristone. ”
The Court of Appeals likely ruled that the statute of limitations prevented plaintiffs from challenging the 2000 approval, but recent moves by the FDA to adjust regulations on the drug have challenged plaintiffs’ claims. He said it was likely to be accepted.
The court accused the FDA of taking a “sand-in-an-ostrich-head” approach to a “very nasty” drug.
Biden last week criticized how lower courts handled the case.
“I think what the court has done is outrageous compared to the conclusion that the FDA is trying to overturn whether something is safe,” he said. “I think it’s outside their domain.”
Petition for Supreme Court Intervention
The Biden administration last week asked the Supreme Court to intervene, and a court filing from Attorney General Elizabeth Preroger stated, An unprecedented lower court order that unleashed regulatory chaos by stopping it.”
Implementing a lower court-ordered rule change to mifepristone would “deny women’s legal access to an FDA drug deemed a safe and effective alternative to invasive surgical abortion.” It would “put the FDA and the organizations they regulate in an impossible position.”
Danco Laboratories, makers of brand-name versions of the drug, which intervened in the case to defend the FDA’s approval of mifepristone, also asked the High Court to intervene.
An attorney for the company said that letting the lower court’s ruling stand “would cause irreparable harm to Danco.”
“The lack of emergency relief from this court will also harm women, the health care system, the pharmaceutical industry, the state’s sovereign interests, and the separation of powers,” attorney Ellsworth told the judge.
Meanwhile, the pro-abortion doctor who filed the lawsuit told the judge that the restrictions placed on drugs by the Court of Appeals were “reasonable.”
“The lower court’s meticulous ruling does not negate the authority’s scientific judgment, but merely requires the authority to follow the law,” the dissenters argued.
This story has been updated with additional details.
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