The Texas ruling also conflicted with one made the same day by a judge in Washington state, directing US authorities to preserve mifepristone access in 17 states and the District of Columbia.
Meanwhile, new suits have been filed in an effort to maintain mifepristone access, including a pair of unrelated suits challenging state restrictions in North Carolina and West Virginia. GenBioPro, the primary US manufacturer of generic mifepristone, is the plaintiff in the West Virginia suit, and is also suing the FDA, arguing that the regulatory body should not comply if the courts order mifepristone off the market.
Even information about abortion could become endangered. In April, state lawmakers in Texas introduced a bill that would outlaw simply providing facts about abortion access.
This legal limbo has bewildered people who are not sure whether they can lawfully access abortion pills. “I think the primary intent of a lot of these [anti-abortion] lawsuits is to confuse, and we definitely see patients coming forward, not clear on what they can and cannot do,” says Kiki Freedman, CEO of Hey Jane.
“It has been extremely stressful for patients and providers alike,” says Cindy Adams, CEO of telehealth abortion provider Choix, which serves six states. The futures of these companies depend on the caprices of a court system frequently in conflict with itself, as well as potential changes in US state and federal laws.
If the Supreme Court does ultimately rule in favor of restricting mifepristone access, the implications will be massive. The courts have never revoked an FDA-approved medication before, so there is no precedent to follow. Nor is it even clear that they can revoke one without establishing that doing so poses an immediate health threat. Even if the courts stop short of a ban, they could roll mifepristone regulations back to what they were pre-pandemic, once again requiring in-person visits for patients—a move that would dismantle the new telehealth access available within the US.
Undermining the FDA’s authority may be too radical even for the most conservative judges. Skye Perryman, a lawyer for GenBioPro and president of the legal advocacy organization Democracy Forward, believes that there will be “industrywide implications” if right-wing interests are able to circumvent the FDA. The move could, for example, hobble the development of new drugs by creating a chaotic regulatory environment. Medications that special interests groups find controversial could also be banned despite evidence that they are safe and effective. Obvious next targets would be birth control medications or vaccines.
More than 500 pharmaceutical executives and industry insiders have already sent a letter urging the courts to respect the FDA’s power to regulate medicines, and filed a brief with the Fifth Circuit. “The district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines,” they wrote. “That outcome would chill crucial research and development, undermine the viability of investments in this important sector, and wreak havoc on drug development.”
Providers Aren’t Backing Down
Honeybee, the US online pharmacy that supplies mifepristone, plans to continue providing it as long as the drug’s FDA approval remains valid, Nouhavandi says. And US-based telehealth providers plan to keep helping patients for as long as they can. Choix CEO Adams thinks that even if the Fifth Circuit bans mifepristone, the ruling will be appealed, and the drug will continue to be available until the Supreme Court weighs in again. “Our sense is the stay is likely to be in place for the next year or so,” she says.
And even if mifepristone becomes illegal in the US, medication abortion will persist. “A total ban would be catastrophic,” Adams says, as it will become an obstacle to prompt healthcare—but she points out that it will not stop overseas suppliers, both nonprofit and commercial, from sending pills into the US.
PrivateEmma, for example, is anticipating an additional swell in requests if mifepristone is banned, Billy Adams says. In addition to ramping up its supply, the group would create a 24/7 hotline staffed by doctors to answer questions.
There’s also a backup plan. Many abortion providers are prepared to switch to a misoprostol-only regimen, providing just the second pill rather than the preferred two-pill regime. Though it is marginally less effective than taking both pills and carries a higher risk of side effects, the World Health Organization and the American College of Obstetricians and Gynecologists both see a misoprostol-only abortion as an acceptable alternative.
Freedman is still optimistic that Hey Jane and other telehealth clinics will continue to be able to do their work. “I would like to maintain faith that the scientific entities of our government will preserve integrity in making decisions around medicine,” she says. “We’d like to believe that logic will prevail in the end.”
