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The Next Big Challenges for Medication Abortion

— Anti-abortion states continue to fight; a possible Trump victory opens door to new strategies

MedpageToday
 A photo of the offices of the Heritage Foundation in Washington, D.C.

In the wake of the Supreme Court's decision to preserve access to mifepristone (Mifeprex) on Thursday, abortion-rights groups worry the threat has not passed while anti-abortion groups agree they're not done fighting against the drug.

In FDA v. the Alliance for Hippocratic Medicine, the justices ruled that the plaintiffs -- a group of anti-abortion doctors who sued over the drug's approval -- lacked the right to sue because they couldn't demonstrate that the FDA's approval and subsequent actions to remove barriers to accessing the drug actually harmed them.

"The bottom line is that these attacks on medication abortion and on all abortions nationwide are absolutely going to continue despite the relief of today's decision," said Julia Kaye, JD, of the American Civil Liberties Union (ACLU) Reproductive Freedom Project, during a press call on Thursday.

During their own press call, Melanie Israel of the Heritage Foundation, a conservative think tank, confirmed that "pro-life states are going to continue enacting their own policies where they can to protect women and girls from these dangerous drugs."

The Next Big Hurdle for Mifepristone

Anti-abortion politicians previously have said that if the original case were to lose on standing, states would attempt to continue the case in Texas, or introduce "copycat lawsuits" in other jurisdictions, Kaye said.

In January, Matthew Kacsmaryk, of the U.S. District Court for the Northern District of Texas, who suspended mifepristone's FDA approval last year, granted a motion to intervene in FDA v. the Alliance for Hippocratic Medicine. (The states also at the Supreme Court level, but were denied the option.)

On Thursday, attorneys general for Kansas and Missouri to continue with their legal challenge.

However, Kaye argued the court's decision means the case was "defective from the start" and, "as a general legal principle, [intervening parties] ... can't rescue a case that is already fatally flawed, because the original plaintiffs should not have been allowed to bring it in the first place."

Carrie Flaxman, JD, a senior legal advisor at Democracy Forward, agreed, noting that "the case should end here."

The states are asserting the same injury as the original plaintiffs "based on 'junk science' claims about how this medication [is] harmful, when it isn't," Flaxman told ľֱ. (In February, Sage Journals retracted three abortion studies, including two cited by Kacsmaryk in that challenged mifepristone's FDA approval.)

On the other hand, Sarah Parshall Perry, JD, of the Heritage Foundation, said the Supreme Court's opinion on Thursday "does not vindicate the safety of mifepristone."

Moreover, when states have a concern about citizens' safety, they have the right to sue under what's known as and "it seems that the door was left open ... for that as being a potentially successful legal theory," Perry said.

Thomas Jipping, JD, also of the Heritage Foundation, said one example of harm put forward by states is the increased costs to Medicaid resulting from women with complications from mifepristone who may seek care in emergency departments. He stressed that any such case that might be introduced would not be a copycat case, but a separate lawsuit with different plaintiffs and different interests, for whom the lack of standing for the original plaintiffs should have no bearing.

States have also to prohibit the use of medication abortion, Jipping noted.

Perry argued such bills are fair, given that the FDA sets "a floor," but not a ceiling, for approvals, meaning that it doesn't prohibit states from regulating the extent to which they "distribute or limit or criminalize the use of any particular drug."

Nonetheless, Jipping and Perry anticipate legal challenges here as well.

The Wild Card Threat: November 6

Abortion-rights groups highlighted other potential barriers to medication abortion access, with former President Donald Trump's possible re-election chief among them.

If Trump were re-elected and Kansas, Missouri, and Idaho continued their legal attack, his Department of Justice could quit defending the FDA, Kaye noted. Or, a Trump-appointed FDA commissioner could potentially impose nationwide restrictions on medication abortion, in direct contradiction to the agency's own scientific review team, which has called such restrictions "medically unnecessary and harmful."

Flaxman said one look at -- a conservative coalition spearheaded by the Heritage Foundation focused on a presidential transition -- makes clear that rescinding FDA approval or restricting the use of mifepristone and limiting the use of telemedicine are clear priorities of a new administration.

Indeed, the , "The FDA is statutorily charged with guaranteeing the safety and efficacy of drugs and therefore should withdraw this drug that is proven to be dangerous to women and by definition fatally unsafe for unborn children ... A bare-minimum policy of limiting abortion pills to the pre-2016 policy of 49 days gestation, returning to the pre-2021 in-person dispensing requirement, and returning to requiring prescribers to report all serious adverse events, not just deaths, to the drug sponsor would increase women's health and safety."

Distribution of Medication Abortion by Mail

Another concern among abortion-rights groups if Trump is elected is a potential prohibition on mailing abortion pills.

Leveraging the -- an 1873 anti-vice law that prohibits the mailing of obscene materials and other articles used to carry out abortions -- has emerged as a probable strategy for anti-abortion groups in the 2024 presidential election, according to KFF.

The Department of Justice under the Biden administration has concluded that "the mailing of mifepristone is not illegal if the sender did not intend for the medication to be used illegally," KFF added.

Yet, Kaye pointed out that Jonathan Mitchell, who served as the Solicitor General of Texas from 2010 to 2015, was the architect of the "bounty hunter" law there, and is on the short list for attorney general in a possible Trump administration has said, "we don't need Congress when we have the Comstock Act of 1873."

"The way that these anti-abortion extremists want to misuse the Comstock Act is entirely wrong from a legal perspective," Kaye argued, and defies "the consensus of the federal appellate courts, U.S. Postal Service, Congress, and the Department of Justice."

But in an on the Heritage Foundation website, Jipping and Perry took a different view, arguing that the Justice Department's Office of Legal Counsel "effectively created a new statute, intentionally neutralizing the current one, so that it poses no obstacle to the Biden administration's agenda of maximizing abortion access."

Under a new administration, Jipping said, the prior Justice Department opinion on the mailing of mifepristone could be "ripe for reconsideration."

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    Shannon Firth has been reporting on health policy as ľֱ's Washington correspondent since 2014. She is also a member of the site's Enterprise & Investigative Reporting team.