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

More than half of American women who choose to terminate a pregnancy do so using a two-drug combination of pills. So you might call this case"daughter ofOnly this time, there is more at stake than abortion rights. It's the entire structure of 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.

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. On the other side is the Alliance for Hippocratic Medicine, which contends that the FDA's loosening of restrictions is unjustified and unsafe.Arguing in the Supreme Court Tuesday on behalf of the anti-abortion doctors is Erin Hawley, wife of Republican Sen. Josh Hawley.

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.Eight months later, the agency looked at data collected during the"natural experiment" created by the pandemic.

"We have just a couple of years under this regime," she says."We have not a lot of data to support it."She also maintains that the data also doesn't support the 2016 changes—for example, the agency's decision to increase approval of the drug for use during the first 10 weeks of pregnancy, instead of the original approval for seven weeks.

 

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