The Supreme Court's blockbuster case over access to abortion drug mifepristone could upend the way the Food and Drug Administration broadly regulates medicines and other products.
Why it matters: Courts for years have given the FDA latitude to make judgments about health and safety based on scientific studies, but a challenge the justices hear Tuesday could set a precedent for courts to substitute their own conclusions for agency decisions.
- Some legal experts believe if the Supreme Court agrees with an appeals court decision reversing FDA's expansion of mifepristone access, outside groups will seek out sympathetic judges to target contraception, certain vaccines or hormone therapies used in gender-affirming care.
What they're saying: "This case is unique because it's really the first time that any sort of case has actually come to question the oversight of the FDA," said Sara Redd, a public health scholar at Emory University.
- If the appeals court's mifepristone decision stands, it "will invite a flood of meritless challenges to the FDA's drug safety and efficacy decisions, including those brought by parties with no concrete interest at stake," drugmakers, executives and investors wrote in a brief to the court.
- The hearing also comes as the Supreme Court weighs another case about a decades-old legal doctrine known as the "Chevron deference" that could significantly limit how much leeway the FDA and other federal agencies have to interpret vaguely worded laws.
Driving the news: The anti-abortion Alliance for Hippocratic Medicine is challenging the way the FDA used an obscure drug safety program known as Risk Evaluation and Mitigation Strategies, or REMS, to expand access to mifepristone in 2016 and 2021 amid additional evidence affirming the pills were safe.
- The agency first decided to expand the time frame of when the drug could be used in pregnancy, from seven weeks to 10 weeks. Then, during the COVID-19 pandemic, it dropped a requirement that the pills be prescribed in person, clearing the way for telehealth abortions via mail-order prescriptions
- The alliance said those decisions put politics above patient safety, pointing to evidence — some of which has since been retracted — of high rates of complications and emergency room visits, although numerous studies have found mifepristone is safe and effective.
Zoom in: REMS, which dates back to 2007, lays out safety protocols for certain drugs, including possible restrictions on their distribution or use.
- Critics have charged that drugmakers have used REMS restrictions in the past to delay cheaper generic drugs from entering the market.
- But anti-abortion forces say the FDA abused its discretion under the program by accelerating its review process for mifepristone, omitting studies or data about how dropping safety rules would impact certain patients and not evaluating the cumulative effects of these changes.
- "This case is less about the decision the FDA actually made than about whether it followed the law when making it," Heritage Foundation senior legal fellow Thomas Jipping wrote.
The other side: The FDA has argued it's not obligated to conduct one study covering all proposed REMS changes, and that evidence it considered supported its belief that mifepristone is safe and effective without a requirement for in-person dispensing, per KFF.
A ruling against the FDA, in addition to potentially inviting more politically motivated challenges to agency approvals, could also bring uncertainty around the statute of limitations for FDA decisions, which now are subject to a six-year limit.
- Mifepristone was approved in 2000, but the 5th U.S. Circuit Court of Appeals suggested it's possible that FDA moves to expand access restarted the clock.
- Overruling the FDA could also limit the agency's ability to approve drugs for broader patient populations than were studied in clinical trials, even if it found enough evidence to justify such a decision.
What we're watching: How much justices on Tuesday home in on the quality of the research cited by anti-abortion plaintiffs — and how much discussion there is on whether the FDA reasonably considered the relevant issues.
