Abortion is back at the Supreme Court Tuesday. This time anti-abortion doctors are challenging the FDA's regulatory actions making abortion pills more accessible.
More than half of American women who choose to terminate a pregnancy do so using a two-drug combination of pills. So you might call this case "daughter of Dobbs," the Supreme Court's 2022 decision reversing Roe v. Wade and leaving the legality of abortion to the states.
Only this time, there is more at stake than abortion rights. It's the entire structure of the FDA's regulatory power to approve drugs and continually evaluate their safety—a system that until now has been widely viewed as the gold standard for both safety and innovation.
On the line, a challenge to the FDA's scientific expertise
"It would be traumatizing to the system," says Marsha Henderson, a former FDA associate commissioner for women's health and a 22-year veteran of the agency.
"We have a very clear scientific approach...it's not just a helter-skelter set of ad hoc opinions," Henderson says. "There are teams of scientists and researchers that participate over many years, starting from phase one pre-clinical all the way through post market...and the information, the data evolve, and they collectively help to enhance the whole research world."
If you start putting politics or junk science into the mix, she warns, the system will collapse.
The challenge in this case was brought by the Alliance for Hippocratic Medicine, an association of anti-abortion doctors founded just months after the Dobbs decision. The group quickly filed a lawsuit seeking to get rid of abortion pills altogether. After a tortuous and tumultuous series of lower court rulings, the Supreme Court intervened to prevent any change to the status quo while it considers the case.
No longer at issue is the FDA's initial approval of the pill, which occurred nearly a quarter century ago and is no longer subject to challenge. Instead, at issue are many of the conditions which were imposed on the drug when it was first approved, conditions that have since been lifted.
Siding with the FDA in this case are virtually all of the major medical associations in the country, as well as pharmaceutical and bio-tech companies, big and small. On the other side is the Alliance for Hippocratic Medicine, which contends that the FDA's loosening of restrictions is unjustified and unsafe.
A senator's wife becomes a new star in the anti-abortion legal world
Arguing in the Supreme Court Tuesday on behalf of the anti-abortion doctors is Erin Hawley, wife of Republican Sen. Josh Hawley.
"Regardless of one's views on abortion," she says, "we should want women to take those drugs with sufficient safeguards, as well as want the FDA to do its job." It didn't do that, she contends.
The drug at the center of the case is mifepristone, marketed by Danco Laboratories as Mifeprex. There is also a generic version of the drug. Since approving mifepristone 24 years ago, the FDA has authorized changes in the drug's dosing, and over time, has lifted many of the initial restrictions on dispensing it.
The dosage was changed in 2016 to reduce the amount of mifepristone by two thirds, and to increase the amount of a second drug, misoprostal, a combination that the FDA found decreased serious complications. That change has not been challenged. What is before the court Tuesday are other FDA decisions that over the last seven years have made access to abortion pills easier.
The FDA lifts some restrictions
In 2016, the FDA approved the use of mifepristone for up to 10 weeks of pregnancy, instead of the previous seven weeks; it reduced the required number of in-person visits to doctors from three to one, and lastly, it permitted the drug to be prescribed and dispensed not just by doctors but, in states that allowed it, also by specially certified midwives and nurse practitioners.
In April 2021, at the height of the pandemic, the FDA temporarily dropped the in-person dispensing requirement, citing the health emergency. That allowed patients, who previously had to go to a clinician's office for their pills, to instead get their prescriptions filled at pharmacies or by mail.
The pandemic changes become permanent
Eight months later, the agency looked at data collected during the "natural experiment" created by the pandemic. It found no difference in serious adverse events whether the drug was dispensed in person or not.
"The safety profile remains the same," whether the pills were taken after an in-person visit or without one, says Jessica Ellsworth, who represents Danco Labs. In a circumstance like this, Ellsworth adds, the federal law which authorizes the FDA to regulate medications, "specifically directs" the agency to loosen restrictions when they are shown to be unnecessary. That's what the agency formally did in 2023, after finding that there was no uptick in serious complications after getting rid of the in-person visit requirement.
Hawley, the lawyer for the anti-abortion doctors association, counters that the data the FDA relied on is inadequate to justify the changes that make mifepristone more accessible.
"We have just a couple of years under this regime," she says. "We have not a lot of data to support it."
The challenge to the 2016 changes
She also maintains that the data also doesn't support the 2016 changes—for example, the agency's decision to increase approval of the drug for use during the first 10 weeks of pregnancy, instead of the original approval for seven weeks.
"The child is larger, the pregnancy tissue is larger, and for that reason, the record shows...that the risk of complications goes up...tenfold from seven weeks to 10 weeks," Hawley says.
"Not true," responds Ellsworth, counsel for Danco. "Not true at all."
She says that in making the 2016 changes—including adjusting the dosing regimen and extending approval for use up to ten weeks of pregnancy—the FDA looked at data that showed fewer complications than when the drug was initially approved for just seven weeks in 2000.
"The number of women who need any follow-up care...went from roughly eight percent to somewhere between two and three percent," Ellsworth says. "So they're just wrong when they suggest that there is some kind of additional complications that were brought on by moving to 70 days."
The procedural hurdle that could throw the case on the dump heap
This entire debate could be for naught at the Supreme Court Tuesday because the anti-abortion doctors first have to get over an important procedural hurdle. Namely, whether they have legal standing to challenge the FDA's mifepristone decisions, since none of their members prescribe the drug for their patients.
Hawley is adamant that they do have standing. "The fact that our pro-life doctors have oriented their practices and even their lives to avoid elective abortion procedures, I think goes to show that those doctors do have standing here."
She also maintains that the FDA's regulations on mifepristone would "conscript" emergency room doctors into performing dilation and curettage procedures after patients come in with incomplete abortions.
But the government counters that the Alliance has been unable to identify a single such occurrence.
No matter which side prevails, a single aspect of this case is truly remarkable. One would be hard pressed to find another case in which the government regulator, the regulated industry, and even the independent watchdog group that frequently criticizes the agency are all on the same side.
"This is a dagger at the heart of the entire industry," says Jeremy Levin, CEO of Ovid Therapeutics, one of the many pharmaceutical companies siding with the government in the case. If the court rules in favor of the anti-abortion doctors, Levin cautions, "the industry would be thrown into complete disarray. Finding new medicines will be nearly impossible to do."
A decision in the case is expected by summer.
