In abortion pill case, US high court may undermine drug regulator

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WASHINGTON: If the US Supreme Court, which on Tuesday hears a sensitive case on the availability of abortion pills, ultimately decides to restrict the...

Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients - REUTERSPIX: If the US Supreme Court, which on Tuesday hears a sensitive case on the availability of abortion pills, ultimately decides to restrict their access, it will impinge on the scientific authority of the federal Food and Drug Administration in unprecedented and consequential ways.

In 2016, the FDA eased some restrictions on the drug's distribution, allowing it to be prescribed through the first 10 weeks of pregnancy ; permitting health professionals including nurses, and not just doctors, to prescribe it; and requiring only one consultation, down from the previous three. “For a judge to second-guess FDA’s expert determination is inappropriate, it is unprecedented, and it’s also extremely dangerous,“ Liz Borkowski, a public and women’s health expert at George Washington University, told AFP.

But “imposing restrictions on the availability of a drug based on a disagreement with the scientific experts at FDA,“ he told AFP, would be “very unprecedented.”The anti-abortion plaintiffs argue that when the FDA was reviewing its rules in 2016, it should have studied the impact of all the changes taken together -- an approach that Grossman called “just a made-up requirement by the plaintiffs.

Experts said the court's ruling could even open the door for drugmakers to sue the FDA to block rivals from marketing competing medications.

 

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