Reproductive health organizations and conservative analysts are sharing their opinions on the FDA’s regulation of the abortion pill mifepristone as oral arguments approach in a case that will bring the abortion debate back to the Supreme Court for the first time since justices overturned Roe v. Wade.
Lawyers representing the Food and Drug Administration and mifepristone manufacturer
The FDA and Danco had appealed a decision from the US Court of Appeals for the Fifth Circuit which found that FDA actions regarding mifepristone beginning in 2016, such as allowing prescriptions via non-physicians and telemedicine, may have been illegal.
Conservative legal analysts are framing the case as a question of whether the FDA breached federal procedures and laws in its decisions on mifepristone, therefore failing to uphold its duty of protecting American consumers.
“Our goal, as long as abortion is legal, is to ensure that the process is as safe and complication-free as possible for women and girls,” Sarah Parshall Perry, a senior legal fellow at The Heritage Foundation, told reporters during a media briefing.
Meanwhile, advocates for reproductive health, former FDA officials, and representatives from the pharmaceutical industry are emphasizing the importance of maintaining access to medication abortion nationwide—which accounts for over 60% of all US abortions—and expressing concerns about the potential impact on pharmaceutical development if the physicians win the case.
“This case is extremely significant from an industry standpoint to ensure that companies investing in potentially life-saving drugs can rely on the courts to respect the FDA’s expert scientific judgment,” said Eva Temkin, chair of the FDA practice at Paul Hastings LLP and a former FDA official, during a call with reporters on Wednesday.
At the Supreme Court
The Supreme Court is set to hear opposing arguments on Tuesday regarding whether the physicians involved in the case have the legal standing to bring the lawsuit, and whether the FDA violated federal law by lifting certain prescribing and dispensing restrictions on the drug in 2016 and 2021.
In its appeal to the Supreme Court, the federal government is asking justices to consider whether the medical groups have Article III standing under the US Constitution to challenge the FDA’s actions. Under Article III, litigants must demonstrate that they have the right to sue by proving they have experienced or will soon face harm, and that the harm is directly linked to the actions of the defendant.
On Thursday, Melanie Israel, a visiting fellow at The Heritage Foundation, raised concerns about doctors potentially dealing with complications after a patient takes mifepristone, noting that abortion providers are not the ones managing any resulting issues.
The FDA, Danco, and advocates for reproductive health argue that the notion that these doctors may need to treat patients with side effects from mifepristone is speculative.
“The parties lack standing because they do not offer medication abortion care,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project, during a press call on Wednesday.
Researchers and medical associations have consistently defended the safety of mifepristone, citing that serious side effects are rare in less than 1% of patients, with major adverse events like blood loss or hospitalization occurring in less than 0.3%, according to the American College of Obstetricians and Gynecologists.
A study published last month in the peer-reviewed journal Nature Medicine followed over 6,000 patients who underwent medication abortion from April 2021 to January 2022. The study concluded that “telehealth medication abortion is effective, safe, and comparable to published rates of in-person medication abortion care,” as stated in the report.
Ushma Upadhyay, the lead author of the study and a professor at the University of California, San Francisco, warned on Wednesday that a Supreme Court ruling reversing the ability to offer telehealth to patients would be devastating.
What’s at Stake
Conservative analysts argue that the case primarily focuses on whether the FDA followed correct procedures in regulating mifepristone, and dismiss concerns that the case will have broad implications for the FDA’s authority.
Parshall Perry criticized the alarmist rhetoric regarding the potential impact on the FDA’s actions on other drugs, asserting that the Supreme Court will only evaluate whether the two FDA decisions were legally sound and supported by evidence required under the Food, Drug, and Cosmetic Act.
Thomas Jipping, another senior legal fellow at The Heritage Foundation, suggested that even if the FDA loses the case, the agency can revisit the issue and consider new drug applications.
However, Elizabeth Jeffords, CEO of small biotech company Iolyx Therapeutics and a board member for the industry trade group Biotechnology Innovation Organization, cautioned that this could introduce uncertainty for investors deciding whether to invest in new therapies.
This case, she explained, “is about whether the FDA is allowed to be the scientific arbiter of what is good and safe for patients.”