番茄社区

The Supreme Court on Thursday preserved the broad access to mifepristone (Mifeprex), used in two-thirds of medication abortions, meaning the drug will remain available by mail and will not require an in-person visit to be prescribed.

In the court's , the justices ruled that the group of anti-abortion doctors who sued over the approval of mifepristone do not actually have the right to sue -- known as "standing" -- because they haven't been harmed by FDA's approval and subsequent actions to remove barriers to accessing the drug.

"The plaintiffs have failed to demonstrate that FDA's relaxed regulatory requirements likely would cause them to suffer an injury," Justice Brett Kavanaugh wrote in the opinion for the case known as FDA v. the Alliance for Hippocratic Medicine.

"For that reason, the federal courts are the wrong forum for addressing the plaintiffs' concerns about FDA's actions," continued Kavanaugh, who was part of the majority to overturn Roe. "The plaintiffs may present their concerns and objections to the president and FDA in the regulatory process, or to Congress and the president in the legislative process. And they may also express their views about abortion and mifepristone to fellow citizens, including in the political and electoral processes."

Part of a two-drug combination with misoprostol, mifepristone is the most commonly used medication for abortion. While misoprostol alone is safe and effective, it is not as effective as the two-drug regimen.

The Alliance case began 5 months after Roe v. Wade was overturned. The plaintiffs initially sought to revoke mifepristone's full approval, and last year a Trump-appointed federal judge, Matthew Kacsmaryk, indeed suspended the approval.

But that ruling was quickly overturned, in part. The 5th U.S. Circuit Court of Appeals determined that the statute of limitations barred the plaintiff from challenging the drug's approval, but held that the Alliance for Hippocratic Medicine could still challenge the FDA's loosening of some of the drug's original restrictions.

Going back to the original restrictions would have required anyone seeking the drug to have an in-person visit with a physician, roll back the gestational limits from 10 weeks to 7 weeks, and ban mifepristone distribution by mail, which the FDA allowed starting in 2021.

However, the Supreme Court put those rulings on hold when it decided to take up the case.

During oral arguments in March, Justice Ketanji Brown Jackson zeroed in on what she saw as a "significant mismatch" between the injury claimed by the plaintiffs and the remedy being pursued.

The injury that's alleged is a "conscience injury," Jackson said, referring to physicians who oppose abortion having to treat patients who have complications after using the drug. "So, the obvious common-sense remedy would be to provide them with an exemption that they don't have to participate in this procedure," she added, noting that federal law already allows for such exemptions.

Even three justices who were in the majority to overturn Roe posed skeptical questions about "standing" to the lawyer for the abortion opponents. Justice Amy Coney Barrett, for example, seemed to doubt that two doctors identified by the plaintiffs' lawyer could show that they were actually harmed by the FDA's actions, saying it was not clear "they ever participated" in an abortion procedure.

Pro-choice groups praised the decision. "Today's ruling is in alignment with medical evidence and with what our communities need and deserve in order to live full, healthy lives," Jamila Perritt, MD, president and CEO of Physicians for Reproductive Health and a Washington ob/gyn, said in a statement. "Regardless of what happens in the court, abortion care, and medication abortion care specifically, will always be a part of that....Mifepristone is a safe and essential medication, and there is no legitimate medical or scientific reason why access to mifepristone should be limited."

"Today's decision from the U.S. Supreme Court provides us with long-awaited relief," said Stella Dantas, MD, president of the American College of Obstetricians and Gynecologists, in a statement. "We now know that patients and clinicians across the country will continue to have access to mifepristone for medication abortion and miscarriage management. Decades of clinical research have proven mifepristone to be safe and effective, and its strong track record of millions of patient uses confirms that data. As the unanimous decision from the court makes clear in no uncertain terms, the people who brought this case were driven solely by a desire to impose their views on others and make it harder for patients to access safe, effective abortion care when they need it."

She added that "Given the unanimity of support for access to mifepristone, we call for the FDA to drop the remaining REMS [risk evaluation and mitigation strategy] requirements, which do not enhance the drug's safety profile and instead only continue to impose burdens on and create barriers for those who prescribe and those who need mifepristone."

On the other side of the issue, Thomas Jipping, JD, a senior legal fellow at the Heritage Foundation, and Melanie Israel, a Heritage Foundation visiting fellow, said in a joint statement that the decision "is not the final judgment on the safety or effectiveness of mifepristone, which we know is unsafe for women and causes up to 1 in 22 women to end up in the emergency room."

"While legal technicalities might allow Biden's FDA to continue manipulating its safety rules to push a pro-abortion agenda at the expense of health and common sense, women and girls taking these chemical abortion drugs are still in danger and largely left to fend for themselves," they said. "Policymakers should be on the side of women's safety by, at a minimum, demanding that the FDA follow its own original safety guidelines, not give abortion drugs a pass because of radical abortion ideology."

The Associated Press contributed to this report.

Comment