The US Supreme Court has granted a full stay in a case over the Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone. The court’s decision was a 7-2 vote and preserves access to the drug as the Biden administration and manufacturer Danco Labs appeal a lower court’s ruling that would impose restrictions on the drug. The decision was applauded by the White House, which has pledged to continue to fight restrictions on the medication.
The case centers on the FDA’s approval of mifepristone, which was challenged in a lawsuit filed by a coalition of anti-abortion doctors and associations. Judge Matthew Kacsmaryk, a Trump-appointee, ruled in favor of the group in April, stating that the FDA exceeded its authority when it approved the drug in 2000.
The case has divided the nation, with more than 150 Republican lawmakers supporting the conservative plaintiffs, while Democrats and leading medical associations have pushed for mifepristone’s continued availability. Medication abortion quickly became the new focus of legal battles over abortion access following the Supreme Court’s decision to overrule Roe v. Wade last June.
“If allowed to take effect, the lower courts’ orders would thwart FDA’s scientific judgment and undermine widespread reliance in a healthcare system that assumes the availability of mifepristone as an alternative to more burdensome and invasive surgical abortions,” Solicitor General Elizabeth Prelogar told the Supreme Court in a filing this week. The Biden administration and Danco Labs have warned of possible wide-ranging consequences if the federal agency’s expertise were to be second-guessed. However, the Alliance Defending Freedom, representing opponents to the abortion pill countered the administration’s concerns amounted to a “sky-is-falling-argument.”
The 5th Circuit Court of Appeals is scheduled to hear oral arguments in the case on May 17th. The case has been watched closely by reproductive rights advocates and opponents, as any decision could have far-reaching implications for access to medication abortion across the country.
Mifepristone, also known by the brand name Mifeprex, is used in combination with misoprostol to terminate early pregnancies of up to 10 weeks’ gestation. The medication has faced restrictions in various states, including mandatory waiting periods and in-person visits with healthcare providers. The COVID-19 pandemic has made access to medication abortion even more difficult, with some states seeking to restrict access to telemedicine appointments and mail-order delivery of the medication.
The FDA approved Mifeprex in 2000 after reviewing extensive clinical data showing the medication to be safe and effective. The medication has been used by more than 4 million individuals in the US and is considered a safe alternative to surgical abortion, which requires anesthesia and often includes an overnight stay in a healthcare facility.
The case before the Supreme Court has implications not only for access to medication abortion but also for the FDA’s authority to regulate prescription drugs. It will be closely watched by medical and legal experts as well as advocacy groups on both sides of the abortion debate.
“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,” President Joe Biden said in a statement. “I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.”
