In the wake of the Supreme Court’s decision to preserve mail-order access to the abortion pill mifepristone, leaders from across the industry are weighing in with their support.
Members of the trade groups the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) plus the American Medical Association (AMA) and CEOs from women's health drugmakers lauded Thursday's ruling.
The High Court’s decision determined that the plaintiff in the case—the Alliance for Hippocratic Medicine—did not have standing to challenge the U.S. FDA’s approval authority.
Mifepristone was originally approved by the FDA in 2000. In 2016, the green light was expanded to allow nurse practitioners to prescribe the drug while increasing the gestational age cutoff from 7 weeks to 10 weeks. In 2021, during the COVID-19 pandemic, the approval was expanded again to remove an in-person administration requirement, which allowed the pill to be shipped through the mail.
Then, in April 2023, the Fifth Circuit Court of Appeals moved to prohibit the pill from being delivered by mail and restricted the time frame mifepristone could be used during pregnancy from 10 weeks to 7 weeks. The Fifth Circuit’s decision dovetailed with the Supreme Court’s controversial decision to overturn the landmark case Roe v. Wade, putting women’s reproductive health under threat.
Industry representatives PhRMA and BIO were staunchly on board with the Supreme Court’s unanimous decision earlier this week.
“We are pleased to see today’s decision from the U.S. Supreme Court which helps provide innovative biopharmaceutical companies the certainty needed to bring future medicines to patients,” Jim Stansel, executive vice president, general counsel and corporate secretary at PhRMA, said in a statement.
BIO, for its part, said it was pleased that the FDA’s authority to review and approve new medicines had been preserved.
“Regulatory certainty is critical to ensuring that vital research can make it from the lab bench to a patient’s bed side,” Phyllis Arthur, EVP and head of healthcare policy and programs at BIO, said in a statement. “Today’s decision ensures patients and drug developers can rely on the rigorous FDA approval process as the scientific and trusted standard for drug approvals."
The AMA also praised the decision, with President-elect Bobby Mukkamala, M.D., noting that efforts to “second guess the FDA’s scientific judgment and roll back access to mifepristone were based on a sham case that not only lacked standing, but relied on speculative allegations and ideological assertions to undermine decades of rigorous scientific review proving the drug is highly safe and effective for both termination of pregnancy and for medical management of miscarriage.”
Mukkamala added that efforts to restrict access to needed abortion medication carries a psychological, physical and economic toll.
“The AMA will continue to support access to safe and effective reproductive health care against the ongoing threats of interference in the practice of medicine,” he stressed.
Meanwhile, GenBioPro, which has manufactured generic mifepristone for over 10 years, warned that despite the Supreme Court’s ruling, threats to mifepristone’s approval and the FDA’s regulatory authority remain.
“We remain committed to lawfully making our evidence-based, essential medications available in the United States and will continue to use all legal and regulatory tools at our disposal to protect access to mifepristone, which is essential to the health of many in the United States,” GenBioPro’s CEO, Evan Masingill, said in an emailed statement.
Danco Laboratories, which markets branded mifepristone under the name Mifiprex, was also pleased with the Supreme Court's decision.
"By rejecting the Fifth Circuit’s radical, unprecedented and unsupportable interpretation of who has standing to sue, the justices reaffirmed longstanding basic principles of administrative law," Abby Long, vice president of marketing and operations at Danco, said in a statement.
Elsewhere, Sabrina Johnson, CEO of women’s health-focused biotech Daré Bioscience, said she was “encouraged by the Supreme Court’s unanimous ruling which upholds the FDA’s authority and underscores the importance of evidence-based decision making in healthcare.”
“In solidarity with the 400+ biotech and pharmaceutical leaders who signed last year’s open letter, we at Daré are committed to advancing innovative products that improve patient outcomes and enhance quality of life for all women and recognize the vital role that the FDA plays in bringing safe and effective treatments to patients,” she said.
And women's health compatriot Femasys said it was "heartened" by the ruling.
"This ruling is a significant step in ensuring women retain access to reproductive healthcare options," Kathy Lee-Sepsick, Femasys' CEO, said. "We believe that preserving regulatory certainty and supporting evidence-based medical practices are critical to the advancement of technologies for the betterment of patient outcomes."
“The plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Brett Kavanaugh wrote for the court on Thursday. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
While the Fifth Circuit’s original decision was put on hold pending Supreme Court review, yesterday’s ruling reverses the mifepristone restriction, ensuring the drug will remain available through telehealth and mail orders.
Editor's note: This story was updated at 10:45am ET on Monday, June 17 with additional comments.