FDA should limit access to ‘dangerous’ chemical abortion drugs, doctors argue in lawsuit

“[T]he FDA never studied the safety of the drugs under the labeled conditions of use despite being required to do so by the Federal Food, Drug, and Cosmetic Act (FFDCA),” the lawsuit asserts.

“The agency also ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls in violation of the Pediatric Research and Equity Act (PREA). And the FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than even surgical abortions.”

The plaintiffs also pointed to the fact that the FDA has progressively rolled back safeguards on the abortion pill; for example, the FDA in 2016 extended the permissible gestational age of the baby to be killed in the abortion from seven to 10 weeks, increasing — as studies have demonstrated — the risk of complications for the mother.

And more recently, the FDA lifted certain restrictions on mifepristone distribution in December 2021, authorizing doctors to prescribe the drugs online and mail the pills, allowing pregnant women to perform early abortions without leaving their homes.

The FDA declined comment, saying in a statement, “The FDA does not comment on possible, pending or ongoing litigation.”

The FDA first approved mifepristone, which is paired with another drug called misoprostol, for earlier abortions in 2000. This type of abortion is currently approved by the FDA for use up to 10 weeks’ gestation. Mifepristone is designed to block progesterone, the hormone that sustains pregnancy, effectively starving the baby. The second pill in the abortion pill regimen, misoprostol, induces labor.

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