Home Politics The Next Big Battle Over Abortion Has Begun

The Next Big Battle Over Abortion Has Begun

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The Next Big Battle Over Abortion Has Begun

In April 2023, Trump-appointed Judge Matthew Kacsmaryk of the Northern District of Texas issued a preliminary ruling on the FDA case, invalidating the agency’s approval of mifepristone. The ruling sent shockwaves far beyond the world of reproductive rights, as it had major ramifications for the entire pharmaceutical industry, as well as the FDA itself; the ruling suggested that the courts could revoke a drug’s approval even after decades on the market.

The U.S. 5th Circuit Court of Appeals strengthened Kacsmaryk’s decision a week later, allowing the drug to remain on the market, but reversed FDA decisions in recent years that made mifepristone easier to prescribe and obtain. That decision limited the time frame within which this can be applied to the first seven weeks of pregnancy and jeopardized access to telemedicine and access to the generic version of the drug.

Following the 5th Circuit’s ruling, the FDA and Danco Laboratories sought emergency relief from the Supreme Court, asking the justices to maintain access until they could hear the case. In his legal filing, Danco aptly described the situation as “regulatory chaos.”

Scotus issued a temporary reprieve, maintaining the status quo; the court ultimately decided to hear the case in December 2023.

As all this unfolded, pro-abortion rights states across the country passed so-called “abortion rights” protect laws, which protects physicians who provide abortion care to pregnant patients in states where abortion is prohibited. This has allowed some providers, including the long-standing group Aid Access, which advocates for medication abortion, to mail abortion pills to people who requested them in states like Louisiana and Arkansas.

Although oral arguments before the Supreme Court begin on Tuesday, it will likely take months before a ruling is delivered. Court watchers suspect a decision will be made in June. With the US presidential elections in the fall, the ruling could become an important campaign issue, especially when it comes to access to abortion helped mobilize voters during the 2022 midterm elections.

If the Supreme Court agrees with the plaintiffs that mifepristone should be removed from the market, some in the pharmaceutical industry worry it will undermine the authority of the FDA, the agency charged with reviewing and approving drugs based on their safety and efficacy.

“This case is not about mifepristone,” said Elizabeth Jeffords, CEO of Iolyx Therapeutics, a company developing drugs for immune and eye diseases. Jeffords is a signatory to one amicus brief filed April 2023 in which 350 pharmaceutical companies, executives and investors came together to challenge the Texas court ruling.

“This case could easily have been about minoxidil against hair loss. It could be about Mylotarg against cancer. It could have been about measles vaccines,” Jeffords said. “This is about whether or not the FDA should be the scientific arbiter of what is good and safe for patients.”

Greer Donley, an associate professor of law at the University of Pittsburgh and a legal expert on abortion, doesn’t think it’s likely the court will completely revoke mifepristone’s approval. Instead, she sees two possible outcomes. The Supreme Court could dismiss the case or reverse the FDA’s 2023 decision to permanently eliminate the in-person provision requirement and allow abortion via telehealth. “This would be an even narrower decision than what the 5th Circuit did, but it would still be quite devastating for abortion access,” she says.

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