A Supreme Court abortion pill case with potential consequences for every other drug

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At issue is 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

Audio will be available later today.Celal Gunes/Anadolu via Getty ImagesThe Supreme Court of the United States building is seen in Washington, D.C., on March 15, 2024.Abortion is back at the Supreme Court Tuesday. This time anti-abortion doctors are challenging the FDA's regulatory actionsMore than half of American women who choose to terminate a pregnancy do so using a two-drug combination of pills.

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.

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

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. "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

Source: Law Daily Report (lawdailyreport.net)

 

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