Health Care

Supreme Court weighs major changes to abortion pill access: Recap

The Supreme Court on Tuesday heard oral arguments in a case that could have sweeping consequences for all Americans’ access to mifepristone, a widely used abortion pill.

The hearing returns the issue of abortion to the Supreme Court almost two years after its landmark decision to overturn constitutional protections to the procedure.

The court is essentially being asked to uphold an appeals court ruling that overrides a series of changes made by the Food and Drug Administration over the past decade, including increasing the gestational age at which mifepristone can be used to up to 10 weeks of pregnancy, allowing the medication to be mailed to patients, lowering the dosage, allowing telehealth prescribing, and permitting providers other than physicians to prescribe the drug.

The stakes of the case were made clear this week when new data showed more than 60 percent of all abortions last year were done through medication.

Activists on both sides rallied outside the court on Tuesday, with arguments wrapping up before noon.

8 months ago

Crowd cheers as lawyers emerge from court

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Abortions rights supporters and opponents, separated by a divider outside the court, cheered as lawyers emerged from the Supreme Court after arguments wrapped.

The sidewalk is crowded with protesters, many holding signs, trying to speak and chant over each other. One group in white coats waved at abortion opponents. Crowds pushed closer to podiums set up on the sidewalks as they waited to hear from speakers.

— Sydney Dunlap

8 months ago

Court adjourns, Prelogar closes with pointed remarks

jchoi

The court has adjourned until 10 a.m. EST tomorrow.

Prelogar gave her closing remarks by noting the other party has not presented any doctors who have had to violate their conscience by providing abortion care.

“The fact that they don’t have a doctor who’s willing to submit that kind of sworn declaration in court I think demonstrates the past harm hasn’t happened,” she stated, adding that she believes these declarations haven’t materialized because the premise is “so speculative.”

“They have said that they fear that there might be some emergency room doctor somewhere someday who might be presented with someone who is suffering an incredibly rare complication,” said Prelogar. “And that the doctor might have to provide treatment notwithstanding the conscience protections. We don’t think that harm has materialized.”

She also argued that voluntarily diverting resources to pursue this litigation by funding studies supporting their stance did not amount to harm.

“If that is enough, then every organization in this country has standing to challenge any federal policy they dislike,” Prelogar said.

8 months ago

Sotomayor says probability of harm ‘infinitesimally small’

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Justice Sotomayor said the probability of harm seemed “infinitesimally small” for doctors who have a conscience objection to treating women who have complications from using abortion pills.

Given the thousands of hospitals and clinics across the country, and the relatively rare occurrence of complications from abortion pills, she said it was unlikely that one doctor will actually be forced to treat a patient who requires aborting a viable pregnancy.

— Colin Meyn

8 months ago

Kagan asks why doctors don’t object with their hospitals

jchoi

Justice Kagan asked why the doctors at the center of this case did not use mechanisms that allowed them to practice conscientious objection to performing abortions.

She noted there is no mention of the doctors having made use of conscientious objection.

Hawley argued it was “impractical” to lodge objections due to the emergency nature of their care. She further argued that federal conscious protections are not intended to apply in emergency situations.

8 months ago

Jackson, Gorsuch question reach of relief

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Justice Gorsuch picked up a line of questioning from Justice Jackson toward Erin Hawley, who is representing groups claiming harm from the FDA’s expansion of abortion pill access.

Gorsuch asked why relief could not be limited to doctors claiming conscience injury, rather than sweeping changes to all Americans access to the medication.

“And this case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on on an FDA rule or any other government actions,” Gorsuch said.

— Colin Meyn

8 months ago

Thomas dubious on claims of harm

jchoi

Justice Thomas expressed doubts over claims that the groups suing to overturn the FDA’s actions have actually experienced harm, questioning how the “diverted time and resources” is not just the cost of pursuing litigation.

Hawley referenced “non-economic” harm. Still, Thomas was skeptical of the stated harms, saying claiming injury resulting from pursuing litigation was “easy to manufacture.”

8 months ago

Conservative Christian legal group opens argument

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Erin Hawley, arguing on behalf of the Christian legal advocacy group Alliance Defending Freedom, opened arguments in front of the court.

Hawley argued the FDA’s actions to expand mifepristone access purposefully forces doctors to manage “abortion drug harm.”

8 months ago

Jackson asks if judges should be parsing medical, scientific studies

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Justice Jackson asked Danco’s attorney if judges should be parsing medical and scientific studies.

Danco’s attorney said the pharmaceutical industry has “significant concerns” over this sort of judicial review as it may threaten the FDA’s gold standard drug approval process.

The attorney stated judges are “not experts in statistics.”

8 months ago

Mifepristone manufacturer warns ruling could affect all drugs

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Danco Laboratories, the manufacturer of a branded version of mifepristone Mifeprex, gave its opening argument in the case.

The lawyer speaking for Danco warned that a ruling overriding the FDA’s approval of mifepristone would affect “virtually every drug approval” the FDA had granted in the same way it approved mifepristone.

Mifeprex is the sole product that Danco distributes.

8 months ago

Abortion rights advocates reveal massive banner

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Abortion rights advocates revealed a yellow banner that spanned the steps of the courthouse with half a million names of people who signed a petition “urging the court to upload the law and protect access to medication abortion.”

Amber Hikes, the ACLU Deputy Executive Director for Strategy & Culture, said that all 50 states are represented on the petition and to fit all the names, the banner had to be made 186 ft. long.

— Sydney Dunlap

8 months ago

Jackson questions remedy plaintiffs are seeking

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Justice Ketanji Brown Jackson expressed skepticism over the remedy that plaintiffs are seeking in the case, blocking other doctors from administering mifepristone due to their personal discomfort with the drug.

Prelogar agreed with Jackson’s questioning, saying there was a “profound mismatch” in the plaintiff’s claimed injury and the remedy they are asking for.

8 months ago

Alito raises Comstock Act

jchoi

Justice Alito brought up concerns that mail-order mifepristone may be linked to high instances of emergency room visits, as prior studies have indicated.

The Comstock Act of 1873 prohibits mailing contraceptives through the mail, which includes abortifacient like mifepristone.

Prelogar acknowledged these observations but noted that half the women in the referenced study who went to the emergency room received no treatment and were likely checking to make sure they weren’t experiencing any side effects.

She stressed that the FDA had “carefully parsed” the studies on mifepristone when making its determinations.

8 months ago

Alito, Thomas press Prelogar on standing

jchoi

Conservative Justices Samuel Alito and Clarence Thomas challenged the government’s argument that plaintiffs in the case lack Article III standing to sue the FDA.

Alito questioned whether the government was arguing there was no one who could sue if the FDA were to have violated the law.

Solicitor General Elizabeth Prelogar pushed back on the premise of the question, saying it would be incorrect to assume that unsafe drugs would be allowed to remain on the market given the FDA’s ongoing surveillance.

—Joseph Choi

8 months ago

Arguments begin with solicitor general

jchoi

The federal government opened its arguments by reiterating it does not believe the plaintiffs in the suit — the Alliance for Hippocratic Medicine — have standing to sue the Food and Drug Administration over its actions to expand access to mifepristone.

Solicitor General Elizabeth Prelogar also argued that an “exceptionally small number of women” experience severe side effects from mifepristone and even less likely that the doctors in this case would be the ones to treat a patient experiencing these side effects, making their argument of experiencing harm speculative.

—Joseph Choi

8 months ago

Hundreds gather outside court

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The Supreme Court case drew hundreds of people to the sidewalk outside the courthouse.

Supporters of abortion held signs reading “Bans off our body” and “Abortion is our right.”

In speeches in front of the steps, abortion opponents pushed for more restrictions on abortion that they said will protect women’s health.

Dr. Susan Bain, a certified obstetrician gynecologist and the regional medical director of three pregnancy centers, said the FDA “recklessly removed safeguards” by not requiring pills to be prescribed by a doctor.

“We are our patient’s last line of defense because her first line of defense, the FDA, an agency that has a duty to protect the public health by ensuring the safety of drugs, failed to do it,” Bain said.

— Sydney Dunlap

8 months ago

Potential for sweeping consequences

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There is no legal precedent for a court to override the Food and Drug Administration’s approval of a drug. But if it were to happen, experts said it could upend the entire drug approval process and make abortion medication out of reach of the people who need it most. 

“That would be a sea change in how courts review health care and drug access in the United States,” said Aadika Singh, senior reproductive justice attorney at Public Rights Project.  

If the Supreme Court upholds the 5th Circuit’s ruling, manufacturers would have to change the drug’s label, and the FDA would need to rewrite its rules and regulations for distribution and use of the drug, which would take time. The manufacturer and distributors won’t be able to market the drug until it gets relabeled.  

While mifepristone will likely stay on the market no matter what the Supreme Court decides, there could be some significant changes to access, even in states where abortion remains legal and protected.  

Read the full story here

— Nathaniel Weixel