Dec 14, 2023 - Health

Supreme Court abortion pill case puts FDA drug review power at risk

Packages of mifepristone tablets at a family planning clinic in Rockville, Maryland. Photo: Anna Moneymaker/Getty Images

The Supreme Court's decision to review the availability of a commonly used abortion pill doesn't just open another chapter in the nation's abortion wars — it's also a direct challenge to the Food and Drug Administration's power to regulate drugs.

Driving the news: The justices on Wednesday gave abortion rights supporters some cause for optimism when they agreed to the Biden administration's request to review lower-court rulings that would sharply curtail access to a drug used in over half of abortions.

  • They simultaneously turned away a request to review the FDA's underlying approval of the pill, mifepristone, which the agency issued in 2000.
  • That basically ensured that the pill will remain available — though possibly subject to more restrictions on how far into a pregnancy it can be taken and how it's dispensed.

The big picture: The key question now becomes whether a court, or states, can dial back the FDA's drug-approval powers and override regulators' scientific judgment.

  • The combined cases the justices agreed to hear pivot around an appeals court ruling that the FDA didn't take into account safety concerns when it made mifepristone more easily accessible in 2016. Among FDA changes in recent years: extending when the drug could be used — from seven weeks into pregnancy to 10 weeks — and allowing patients to get the medication by mail.
  • If the high court agrees, it could limit abortion access even in those states that protect access to the procedure.
  • "In one fell swoop, SCOTUS will decide access to the most common abortion method and the functioning of the FDA," Lawrence Gostin, a Georgetown Law professor who supports abortion rights, wrote on X. "Reproductive freedom is at stake as well as the scientific judgments of health agencies."

Catch up quick: The legality of medication abortion had been in doubt ever since a federal judge in Texas moved in April to force the FDA to pull its approval of mifepristone, in response to a suit from anti-abortion forces.

  • The Supreme Court temporarily blocked any restrictions from taking effect while challenges to the FDA's authority played out.
  • In August, a three-judge panel at the 5th U.S. Circuit Court of Appeals blocked the Texas judge's decision but ruled against the FDA's expanded access to the drug.
  • Justices on Wednesday agreed to requests to review the case from the Justice Department and mifepristone manufacturer Danco Laboratories, who argued the 5th Circuit ruling destabilized the drug industry and created confusion to women and the health system.
  • The 5th Circuit decision "supplants FDA's role and circumvents the regular channels for withdrawal of drug approval that safeguard the due process interests of drug sponsors," the drug lobby PhRMA wrote in a brief urging the Supreme Court to review that ruling.

What they're saying: Stephen Vladeck, a federal courts expert at the University of Texas School of Law, said it's highly likely the Supreme Court will rule on a procedural issue that will erase the lower-court rulings and leave FDA approvals and the regulatory system untouched.

  • Katie Daniel, Susan B. Anthony Pro-Life America's state policy director, said the FDA put politics over its duty to protect health and safety by lifting restrictions like an in-person dispensing requirement for the pill, which she said "flies in the face of science and common sense."

The court could hear the case by the spring, meaning that a ruling could come before the 2024 election — and with its 2022 decision to strike down Roe v. Wade still resonating.

The bottom line: Some political analysts believe that no matter what the court decides, the next Republican president will be under immense pressure to use executive authority to limit access to the pill.

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