Abortion pill ruling offers measure of relief for FDA, biotech
17 Jun 2024
Drug ApprovalPatent Infringement
The Supreme Court’s unanimous decision last week to reject a conservative group’s challenge to the Food and Drug Administration’s regulation of the abortion pill mifepristone could help to bolster the agency’s decision-making authority.
In a ruling Thursday, the Supreme Court reversed an appeals court verdict that would have limited access to mifepristone, finding the plaintiffs lacked a legal basis to sue the FDA. Their 9-0 opinion allows changes made by the FDA to the drug’s permitted use to remain in effect, including prescriptions by mail.
Biotechnology leaders had voiced concerns over the case’s potential impact on the drug industry, seeing in an early district court ruling a threat to the current regulatory landscape. PhRMA, the powerful lobby for the industry, said in a statement last week that the Supreme Court’s verdict “helps provide innovative biopharmaceutical companies the certainty needed to bring future medicines to patients.”
“I think it shows the Supreme Court recognized the grave threat this case poses to the integrity of the entire FDA drug approval system,” said Rachel Sher, a partner at Manatt, Phelps & Phillip. “The court found that [the Alliance’s case] doesn't demonstrate standing to challenge what was a decade's old, scientifically-based decision by the FDA to approve this drug that has been demonstrated time and again to be safe and effective.”
Lawyers for the group, called the Alliance for Hippocratic Medicine, had argued that extensions to mifepristone’s approval granted by the FDA in 2016 and 2021 caused injury to individuals from complications, and posed “harm” to the conscience of doctors who might have to treat those complications. Most justices appeared skeptical of the plaintiffs’ case during oral arguments in March, pushback that was reflected in their unanimous opinion.
“Allowing doctors or other healthcare providers to challenge general safety regulations as unlawfully lax would be an unprecedented and limitless approach and would allow doctors to sue in federal court to challenge almost any policy affecting public health,” wrote Justice Brett Kavanaugh, in the court’s opinion.
Mifepristone has been approved in the U.S. for almost a quarter century, and is one of two pills commonly used to terminate pregnancies within the first trimester. Medication abortions now account for more than 60% of all abortions in the U.S., a share that’s grown since the Dobbs decision in 2022. The FDA granted expanded access under a Risk Evaluation and Mitigation Strategy, or REMS, designed to ensure mifepristone’s safe use.
Daphne Zohar, CEO of Seaport Therapeutics, noted how the Supreme Court acknowledged all drugs carry risks and that the case, if successful, would have allowed any healthcare provider to challenge the FDA. Zohar, who until recently ran PureTech Health, is also a member of an advisory board to the trade group BIO.
“The court rejected this idea, which is a very important win,” Zohar wrote in an email to BioPharma Dive. “[T]he alternative would have set a dangerous precedent and would have had serious implications for our drug development system, creating regulatory uncertainty and stifling innovation.”
Zohar is also a member of the Biotech Sisterhood, a group of female biotech executives that sent out public letters and filed briefs warning how the case would “chill drug development, and preclude postapproval improvements, effectively freezing drugs in time.”
The FDA’s approval reviews are lengthy and exacting, requiring documented evidence of a drug’s safety and efficacy. Withdrawal of a drug’s approval is also a long process that can be initiated either by a manufacturer or through citizen petition requests that can be submitted by individuals or groups. A different ruling from the Supreme Court might have eroded some of the FDA’s decision-making discretion.
“The court, in this opinion, significantly recognized that there is no drug on the market without risks, and that we look to the FDA and its expert scientific judgment to decide whether the risks are outweighed by the benefits,” Sher said.
Mifepristone’s place on the market could still be challenged, however. Because the court focused on the question of standing, the justices did not debate the merits of the FDA’s actions directly, which could leave room for new challenges. Missouri, Kansas and Idaho, which previously tried to intervene, plan to challenge the drug’s approval in the future.
“While SCOTUS didn’t address the specifics of the case and ruled unanimously on the technical question of ‘standing,’ the ruling is nonetheless a victory for FDA and its authorities, for science and evidence, and, most important, for women and their rights,” John Maraganore, the former CEO of Alnylam Pharmaceuticals, wrote in an email to BioPharma Dive.
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