Abortion is back at the Supreme Court Tuesday. This time anti-abortion doctors are challenging the FDA’s regulatory actions making abortion pills more accessible.
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 of Dobbs,” the Supreme Court’s 2022 decision reversing Roe v. Wade and leaving the legality of abortion to the states.
Only 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.
On the line, a challenge to the FDA’s scientific expertise
“It would be traumatizing to the system,” says Marsha Henderson, a former FDA associate commissioner for women’s health and a 22-year veteran of the agency.
“We have a very clear scientific approach…it’s not just a helter-skelter set of ad hoc opinions,” Henderson says. “There are teams of scientists and researchers that participate over many years, starting from phase one pre-clinical all the way through post market…and the information, the data evolve, and they collectively help to enhance the whole research world.”
If you start putting politics or junk science into the mix, she warns, the system will collapse.
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A senator’s wife becomes a new star in the anti-abortion legal world
Arguing in the Supreme Court Tuesday on behalf of the anti-abortion doctors is Erin Hawley, wife of Republican Sen. Josh Hawley.
“Regardless of one’s views on abortion,” she says, “we should want women to take those drugs with sufficient safeguards, as well as want the FDA to do its job.” It didn’t do that, she contends.
The drug at the center of the case is mifepristone, marketed by Danco Laboratories as Mifeprex. There is also a generic version of the drug. Since approving mifepristone 24 years ago, the FDA has authorized changes in the drug’s dosing, and over time, has lifted many of the initial restrictions on dispensing it.
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Article URL : https://www.npr.org/2024/03/26/1240006204/fda-supreme-court-abortion-pill-mifepristone