…Supreme Court analyst explains what justices’ public dissent say about state of the Court
The Supreme Court on Friday protected access to a widely used abortion drug by freezing lower-court rulings that placed restrictions on its usage as appeals play out.
As a result, the US Food and Drug Administration’s approval of the drug mifepristone and subsequent actions that made it more easily accessible will remain in place while appeals play out – potentially for months to come.
Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.
Mifepristone is taken first to stop the pregnancy, followed by Misoprostol to induce bleeding. – In the wake of Friday’s ruling by the US Supreme Court striking down Roe v Wade and the federally protected right to an abortion, women from Texas and other states are traveling to clinics like the Women’s Reproductive Health Clinic in New Mexico for legal abortion services under the state’s more liberal laws. – RESTRICTED TO EDITORIAL USE (Photo by Robyn Beck / AFP) / RESTRICTED TO EDITORIAL USE (Photo by ROBYN BECK/AFP via Getty Images)
Supreme Court protects access to a widely used abortion drug
The Friday night move is a striking victory for the Biden administration and its allies in the abortion rights community, which suffered a withering defeat at the Supreme Court last year when the conservative majority reversed the Roe v. Wade precedent that protected abortion rights nationwide.
The court’s brief, unsigned order did not explain why it granted the request by the Biden administration and a manufacturer of the drug to intervene. Justices Clarence Thomas and Samuel Alito publicly dissented; the votes of the other justices were not disclosed.
The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade, triggering conservative states across the country to either ban or severely restrict the procedure. How the dispute over medication abortion is ultimately resolved could make it more difficult for women to obtain abortion, even in the states that still allow it.
At issue is the scope of FDA’s authority to regulate mifepristone, a drug that the medical community has deemed safe and effective. Mifepristone has been used by millions of women across the country in the more than two decades that it has been on the market.
The next step in the litigation will be a hearing in front of a New Orleans-based federal appeals court on May 17.
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“The case could well come back to the justices once the Fifth Circuit rules, but nothing is going to change with respect to mifepristone access until and unless the court both takes the case on the merits and sides with the challengers,” said Steve Vladeck, CNN Supreme Court analyst and professor at the University of Texas School of Law. “That’s not going to happen for a long time – if ever.”
President Joe Biden praised the order.
“As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts,” Biden said in a statement Friday evening.
Biden also urged Americans “to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v Wade.”
A lawyer for the group of doctors who brought the challenge downplayed the order. “As is common practice, the Supreme Court has decided to maintain the status quo,” Erik Baptist, a lawyer for Alliance Defending Freedom, said in a statement.
“Our case seeking to put women’s health above politics continues on an expedited basis in the lower courts,” Baptist added. “We look forward to a final outcome in this case that will hold the FDA accountable.”
Alito suggests government might have ignored mifepristone ban
In his dissent, Alito said he voted to deny the request for a stay because the 5th Circuit has scheduled such an expedited hearing on the merits of the dispute.
He suggested that allowing the restrictions to remain in place would not lead to “any real harm during the presumably short period at issue.”
Alito wrote that the stay would not “remove mifepristone from the market” but would have simply restored “the circumstances that existed” from the time the drug was approved in 2000 to when the FDA passed new regulations to ease access to the pill starting in 2016.
“The Government has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement action to which it has strong objections,” Alito wrote.
No other justice joined his dissent.
Defenders of abortion pills react
Danco Laboratories, the manufacturer of the drug that intervened in the case to defend mifepristone’s approval, cheered the Friday order for preserving “crucial access to a drug relied on by millions of patients.”
“The lower courts’ reversal of longstanding FDA approvals has caused widespread chaos among providers, patients, and healthcare systems. Today’s order provides continuity to all concerned as we litigate the underlying issues in this case,” Jessica Ellsworth, Danco’s attorney, said in a statement.
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The other manufacturer of the drug, GenBioPro, did not intervene in the lawsuit, but the FDA’s approval of their product – the generic version of the abortion pill – would have been suspended had the Supreme Court left the lower court rulings in effect.
“Today’s Supreme Court ruling keeps mifepristone lawful and available,” the company’s CEO Evan Masingill said in a statement responding to Friday night’s order. “GenBioPro is continuing to serve its customers and is committed to providing our evidence-based, essential medication to all who need it.”
US Department of Health and Human Services Secretary Xavier Becerra said the order was ” an important step in the right direction” as the administration “vigorously” fights “to defend the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.”
“We are confident the law is on our side and remain focused on prevailing in court,” he said. The Justice Department declined to comment.
Lower court rulings that second guessed FDA’s assessments
The legal controversy began last November when a group representing doctors who oppose abortion filed suit, arguing that the FDA had not done enough to ensure the safety of the drug some two decades earlier.
US District Court Judge Matthew Kacsmaryk, a Trump appointee, issued a broad ruling on April 7 that blocked the approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible. He, however, delayed the effective date of his ruling by seven days to give time for an appeal.
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Rejecting the consensus of the medical community, Kacsmaryk raised questions about the safety of the drug, peppering his opinion with jargon that is often used by opponents of abortion. He labeled doctors who perform the procedure “abortionists” and explained that he would reject the term “fetus” in favor of the more inflammatory “unborn human.” Instead of referring to the procedure as a “medication abortion,” he insisted on calling it a “chemical abortion.”
The FDA, Kacsmaryk contended at one point, “acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions.”
Mainstream medical associations have rebuked his assertions about the dangers of the drug, and mifepristone has been shown to be safer than common medicines like penicillin and Viagra.
On a key threshold issue, the judge insisted that the plaintiffs – doctors who do not use or prescribe the drug – had the legal right to be in court to make their case because they allege that the use of the drug could “overwhelm” the medical system.
Stunned by the breadth of the decision, the Biden administration and Danco, a manufacturer of the drug, filed an appeal with the 5th US Circuit Court of Appeals.
The appeals court ultimately let stand the government’s approval of the drug, but agreed with Kacsmaryk that access could be limited.
A divided three-judge panel ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers, rather than traveling to a clinic or hospital to obtain the drug in person. It also effectively revokes the 2019 approval of the generic version of the drug. The restrictions also affect the instructions on the label for the medication, shortening the window of obtaining the pill to seven weeks into pregnancy as opposed to 10.
It’s possible however that even with the ruling in effect, some providers could go “off-label” and continue to prescribe mifepristone up until 10 weeks.
The 5th Circuit claimed that the FDA’s rules for the drug created “an exceedingly unusual regime,” and that the anti-abortion doctors had the right to sue over it because they would “necessarily be injured by the consequences” of the FDA’s decision “to cut out doctors from the prescription and administration of mifepristone.”
The appeals court said that the statute of limitations likely barred the plaintiffs from challenging the 2000 approval, but that they were likely to succeed in their claims against the FDA’s more recent moves to adjust the rules around the drug.
The court accused the FDA of having an “ostrich’s-head-in-the-sand approach” to the drug that was “deeply troubling.”
Biden last week decried how those lower courts had handled the case.
“I think it’s outrageous what the court has done, relative to concluding that they’re going to overrule the FDA on whether something is safe or not,” he said. “I think it’s out of their domain.”
Pleas for the Supreme Court to intervene
The Biden administration asked the Supreme Court to intervene last week, with court filings from Solicitor General Elizabeth Prelogar citing “unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.”
Implementing the changes to mifepristone’s rules ordered by the lower courts would “deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion,” while putting the FDA and the entities they regulate “in an impossible position.”
Danco Laboratories, a manufacturer of the brand-name version of the drug that had intervened in the case to defend FDA’s approval of mifepristone, also requested the high court to step in.
Leaving the lower court rulings in place, the company’s attorney said in filings, would “irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations.”
“The lack of emergency relief from this Court will also harm women, the healthcare system, the pharmaceutical industry, States’ sovereignty interests, and the separation-of-powers,” the attorney, Ellsworth, told the justices.
The anti-abortion doctors who had brought the case meanwhile told the justices that the restrictions the appeals court placed on the drug were “reasonable.”
“The lower courts’ meticulous decisions do not second-guess the agency’s scientific determinations; they merely require the agency to follow the law,” the challengers .
What to know about the abortion pill mifepristone
Mifepristone was approved in 2000 by the Food and Drug Administration (FDA), the government agency responsible for determining the safety of drugs and medication. But earlier this month, a conservative judge in the state of Texas issued a ruling barring the sale of mifepristone beginning on April 7.
That decision was quickly appealed by the Biden administration and has now made its way to the Supreme Court, which is expected to issue a ruling before a self-imposed deadline of midnight on Friday.
What is mifepristone, why is it being contested, and what would restricting access to its use mean for people in the US? Al Jazeera takes you through the issues.
What is mifepristone?
Mifepristone is a widely used abortion pill, often taken as the first in a two-part procedure, including a second pill called misoprostol. Taken together, the pills can be used to stop pregnancy for a period of up to 10 weeks.
Misoprostol can be taken as a single pill to terminate a pregnancy, but scientists say that taking it along with mifepristone is more effective.
Mifepristone was approved by the FDA in September 2000 for use up to seven weeks of pregnancy. In 2016, the FDA extended its use through 10 weeks in an effort to ease access.
In recent years, pills have become the dominant form of abortion in the US, accounting for more than half of all abortions. In 2020, the Guttmacher Institute, a pro-abortion rights group, found that 53 percent of all legal US abortions were conducted through medication, up from 39 percent in 2017.
Is it safe to use?
Yes. There is a strong scientific and medical consensus that mifepristone is a safe way to terminate a pregnancy, and it has been used by millions of people in the US and around the world for decades.
Mifepristone can be taken alone in a private place like a home, with some side effects such as bleeding and brief abdominal pain. Serious complications can occur but are rare.
In January, the FDA expanded access to the pill by approving it for sale at US pharmacies and permanently allowing people to receive the medication in the mail, continuing a policy implemented during the COVID-19 pandemic.
Why is mifepristone’s use being challenged?
In June 2022, the US Supreme Court, with a 6-3 conservative majority, ruled to overturn Roe vs Wade, a 1973 case that had enshrined the constitutional right to an abortion.
Many Republican-led states across the country had already enacted various restrictions meant to diminish access to abortion. However, with the repeal of the landmark ruling, states gained the ability to ban abortion entirely, and more than a dozen states have enacted such bans in the time since.
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Anti-abortion rights demonstrators in front of the Supreme Court in June, when it rolled back abortion rights in a controversial ruling [File: Jacquelyn Martin/AP Photo] Anti-abortion rights advocates view pills like mifepristone as an important fight in the ongoing battle to determine access to reproductive health services and have pushed for greater restrictions on their use.
In Texas, a coalition of anti-abortion medical providers called the Alliance for Hippocratic Medicine filed a lawsuit challenging the FDA’s approval of mifepristone, stating that the pill is unsafe and should never have been approved.
The case went before District Judge Matthew Kacsmaryk, a Trump appointee with a reputation for sympathy to conservative causes, who ruled in favour of the anti-abortion rights group’s request for an injunction on mifepristone on April 7.
If allowed to stand, the decision would further restrict access to abortion services in the US, where millions of people have already lost or experienced diminished access in the aftermath of the decision to overturn the Roe vs Wade ruling.
What happened next?
The injunction would have suspended mifepristone sales in the US as litigation continues, but Kacsmaryk’s decision gave the Biden administration seven days to appeal before the order went into effect.
The decision is considered the first instance of a judge challenging the authority of the FDA to make decisions regarding the health and safety of a medication, and health experts have warned that the ruling, if allowed to stand, would diminish the agency’s authority.
Three days later, the Biden administration filed an emergency motion asking an appeals court to temporarily halt Kacsmaryk’s injunction, stating that it would undermine the authority of the FDA and diminish access to necessary healthcare.
White House Press Secretary Karine Jean-Pierre said at the time that the government stood by the FDA’s approval of mifepristone. She added that the administration expected the case would end up before the Supreme Court and was “pretty confident that we’re going to win”.
On April 13, an appeals court in New Orleans rolled back some of the restrictions from Kacsmaryk’s ruling, keeping the pill legal but upholding significant restrictions, revoking the ability to receive it in the mail and requiring an in-person visit to the doctor.
The Biden administration quickly appealed that ruling to the Supreme Court, which issued a temporary stay on the restrictions a week ago, extending the stay for a two-day period on Wednesday.
It is scheduled to issue a ruling by a self-imposed deadline of Friday before 12pm US Eastern Time (4:00 GMT Saturday).