The Texas ruling also conflicted with a decision handed down the same day by a Washington state judge, directing US authorities retain access to mifepristone in 17 states and the District of Columbia.
Meanwhile, new lawsuits have been filed to preserve access to mifepristone, including a few unrelated lawsuits challenging state restrictions in North Carolina And West Virginia. GenBioPro, the leading US manufacturer of generic mifepristone, is the plaintiff in the West Virginia lawsuit and is also to sue the FDA, arguing that the regulatory body should not comply if the courts ordered mifepristone off the market.
Even information about abortion can be compromised. In April, state lawmakers in Texas introduced a bill that would ban simply providing facts about abortion access.
This legal limbo has baffled people who aren’t sure they have legal access to abortion pills. “I think that’s the primary intent of a lot of this [anti-abortion] litigation is confusing, and we’re definitely seeing patients coming forward, not clear on what they can and can’t do,” says Kiki Freedman, CEO of Hey Jane.
“It was extremely stressful for both patients and caregivers,” said Cindy Adams, CEO of abortion provider Choix, which serves six states. The future of these companies depends on the vagaries of an often self-contradictory legal system, as well as possible changes in US state and federal laws.
If the Supreme Court finally rules in favor of restricting access to mifepristone, the implications will be enormous. The courts have never before repealed an FDA-approved drug, so there’s no precedent to follow. Nor is it even clear that they can withdraw one without determining that it poses an immediate threat to health. Even if the courts stop banning them, they could revert the rules on mifepristone to what they were pre-pandemic, again requiring in-person visits for patients – a move that the new access to telehealth available in the US, would dismantle.
Undermining the FDA’s authority may be too radical for even the most conservative judges. Skye Perryman, a GenBioPro attorney and president of the legal advocacy organization Democracy Forward, believes there will be “industry-wide implications” if right-wing interests can bypass the FDA. For example, the move could hamper the development of new drugs by creating a chaotic regulatory environment. Drugs that interest groups find controversial may also be banned despite evidence that they are safe and effective. Obvious next targets are contraceptive drugs or vaccines.
More than 500 pharmaceutical executives and industry insiders have already sent a letter insist the courts to uphold the FDA’s authority to regulate drugs, and filed a letter with the Fifth Circuit. “The district court’s lawless opinion will allow any plaintiff to stall drug approvals, disrupting patient access to critical drugs,” they wrote. and wreak havoc on drug development.”
Providers don’t back down
Honeybee, the U.S. online pharmacy that supplies mifepristone, plans to continue supplying it as long as the drug’s FDA approval remains valid, Nouhavandi says. And US-based telehealth providers plan to continue serving patients for as long as possible. Choix CEO Adams thinks that even if the Fifth Circuit bans mifepristone, the ruling will be appealed and the drug will remain available until the Supreme Court rules again. “Our feeling is that the stay will probably be in effect for the next year,” she says.
And even if mifepristone becomes illegal in the US, drug abortion will continue. “A blanket ban would be catastrophic,” says Adams, because it will become an obstacle to rapid health care, but she points out that it won’t stop overseas suppliers, both non-profit and commercial, from sending pills to the U.S. .
For example, PrivateEmma expects an extra wave of requests if mifepristone is banned, says Billy Adams. In addition to ramping up the supply, the group would create a 24/7 hotline with doctors to answer questions.
There is also a backup plan. Many abortion providers are willing to switch to a misoprostol-only regimen, giving only the second pill instead of the preferred two-pill regimen. While it is slightly less effective than taking either pill and carries a higher risk of side effects, the World Health Organization and the American College of Obstetricians and Gynecologists both see misoprostol-only abortion as an acceptable alternative.
Freedman is still optimistic that Hey Jane and other telehealth clinics can continue to operate. “I would like to trust that our government’s scientific entities will maintain integrity in making decisions about medicine,” she says. “We’d like to believe that logic will ultimately prevail.”
Updated 6/21/23, 1PM EST: This story has been updated to update the percentage increase in requests for abortion pills Hey Jane received following the Supreme Court ruling Dobb’s decision.