A Supreme Court majority on Tuesday appeared deeply skeptical of efforts to severely restrict access to a widely used abortion pill, questioning whether a group of anti-abortion doctors and organizations had the right to challenge the drug’s approval Food and Drug Administration challenge.
During the nearly two-hour debate, justices from across the ideological spectrum appeared likely to side with the federal government, with only two justices, conservatives Samuel A. Alito Jr. and possibly Clarence Thomas, appearing to favor limiting the distribution of the pill.
Judge Neil M. Gorsuch described the case as an effort by “a handful of individuals” and questioned whether it was “a prime example of how what could be a small lawsuit could turn a state legislature into an FDA rule or other federal law . “Government measures.”
The challenge involves mifepristone, a drug approved by the FDA more than two decades ago that is used in nearly two-thirds of abortions in the country. At issue is whether the agency acted appropriately in expanding access to the drug in 2016 and again in 2021 by allowing doctors to prescribe it via telemedicine and send the pills by mail.
The Biden administration had asked the Supreme Court to intervene after a three-judge federal appeals court panel favored curbing the drug’s spread. Until the judges decide, access to mifepristone will remain unchanged, delaying the possibility of sudden restrictions on its availability.
Even if the court maintains full access to mifepristone, the pills remain illegal in more than a dozen states that have enacted near-total bans on abortion. These bans do not distinguish between medical and surgical abortion.
The case brought the issue of abortion access back to the Supreme Court, even though the conservative majority in the case that overturned Roe v. Wade, Dobbs v. Jackson Women’s Health Organization, had said that it would refer the issue “to the people and… “would be left to their elected representatives.”
Judge Gorsuch’s pointed questioning was echoed by other justices, who asked whether any of the doctors involved in the lawsuit could prove that they had been harmed by the federal government’s approval and regulation of the abortion drug.
In one case, Justice Elena Kagan asked counsel about the anti-abortion groups they relied on to prove actual injury.
“You need a person,” Justice Kagan said. “So who is your person?”
Although the argument contained detailed descriptions of abortion, including questions about placental tissue and bleeding, the focus on the question of whether challengers even had standing to sue suggested that the justices could rule for the FDA without considering the merits of the case if necessary.
Since the decision to overturn Roe v. Wade ended a nationwide right that had existed for nearly half a century, abortion pills have increasingly become the focus of political and legal battles.
The case began in November 2022, when a group of anti-abortion doctors and medical organizations sued the FDA, claiming the agency made a mistake in approving the drug in 2000.
A federal judge in Texas, Matthew J. Kacsmaryk, issued a preliminary ruling last spring invalidating the FDA’s approval of the drug. In August, a panel of federal appeals judges in New Orleans scaled back its ruling, ruling that mifepristone should remain legal but imposing significant access restrictions. The focus was on the FDA’s decisions on telemedicine and pills by mail.
A ruling for the anti-abortion doctors could impact the FDA’s regulatory authority, potentially calling into question the agency’s ability to approve and distribute other drugs.
Attorney General Elizabeth B. Prelogar warned on behalf of the government of the far-reaching consequences for both the pharmaceutical industry and reproductive rights. “It is damaging to the pharmaceutical industry, which is sounding the alarm on this case and saying this would destabilize the system of approving and regulating medicines,” she said. “And it harms women who need access to medication abortion under conditions deemed safe and effective by the FDA.”
To file the legal challenge, anti-abortion doctors and groups must prove that they will suffer concrete harm if the pill remains widely used. Lawyers call this requirement standing.
Whether anti-abortion groups had met this basic threshold took up much of the survey.
The argument centered on statements made by seven anti-abortion doctors in the lawsuit. They said they suffered moral harm from the availability of the abortion pill because they may be forced to treat women who come to the emergency room with complications from the pill, including heavy bleeding.
Erin M. Hawley, the lawyer for the anti-abortion doctors, claimed that her clients were harmed by the abortion pill and were acting against their conscience. They are forced to treat women in “life-threatening situations where a doctor has the choice of either running off and trying to find someone else or treating the woman bleeding on the table in the emergency room,” she said.
Ms. Hawley, who is married to Josh Hawley, a Republican senator from Missouri who was involved in anti-abortion legislation, added that in an emergency it was “a lot to ask” for “doctors to go up to the top floor and…” argue this with the general counsel when the federal government tells them they have no conscience protections.”
Ms. Prelogar claimed that the claims of anti-abortion doctors and groups are “based on a long chain of remote contingencies,” with scientific studies showing that medical complications from abortion pills are very rare.
She argued that there was little chance that doctors who opposed abortions would have to treat patients. If these doctors wanted to opt out, they could do so under federal conscience protections, i.e.
Abortion opponents made generalizations and found no concrete example of a doctor who had to act against their conscience, Ms. Prelogar said, thereby showing “that the harm did not happen in the past.”
She called on the judges to “put an end to this case.”
Judge Thomas asked Ms. Prelogar who could file such a lawsuit if she was correct that the doctors could not prove direct injury.
When Ms. Prelogar objected, Justice Alito, who wrote the majority opinion in Dobbs, returned to the point.
“Is there anyone who could challenge in court the legality of what the FDA did here in this particular case?” he asked.
“In this particular case, I think the answer is no,” Ms. Prelogar responded.
“Well, that wasn’t my question,” Justice Alito said. “Is there anyone who can do that?”
Ms Prelogar said there was “a profound mismatch here” between the harm the doctors claimed – that they were being forced to have an abortion by treating women who had taken an abortion pill – and the remedy they were seeking , to end access to the drug for everyone.
Judge Ketanji Brown Jackson explored the idea that if the justices limited the FDA’s regulatory powers, it could “be incumbent on the justices to analyze medical and scientific studies” to determine whether a drug is safe.
Jessica L. Ellsworth, the attorney for Danco Laboratories, a manufacturer of the drug, agreed that such a system would raise concerns for “pharmaceutical companies that rely on the FDA’s gold standard review process to approve their drugs and then sell them.” “Products consistent with this considered judgment.”
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2024-03-27 00:24:42
www.nytimes.com