GenBioPro CEO Evan Masingill in a statement said the company expects the FDA to uphold previous findings that its products are safe and effective.
“Ensuring legal access to mifepristone in the long term is vital to women’s healthcare and reproductive freedom,” he said.
Broader abortion access backdrop
The FDA first announced the review of mifepristone, which is used in more than 60% of U.S. abortions, last year. The study has reportedly been delayed until after the November midterm elections.
Nearly half of U.S. states have banned or severely restricted access to abortion since the U.S. Supreme Court rolled back the constitutional right to undergo the procedure in 2022. That has driven a surge in medication abortion and spurred a series of legal battles over access to the drugs.
Medication abortion is a two-drug regimen consisting of mifepristone followed by misoprostol used to terminate a pregnancy within the first 10 weeks.
Five states have filed three separate lawsuits, which generally claim the FDA has failed to thoroughly evaluate the safety and effectiveness of mifepristone since its initial approval and disregarded the risks to the women who take it.
Most major medical groups, and the FDA at various times over the last quarter-century, have said that mifepristone is safe and effective when taken as directed and that serious adverse events are rare.
Lawsuit paused pending FDA review
A federal judge paused a lawsuit by Florida and Texas seeking to severely limit access to the abortion pill mifepristone nationwide while President Donald Trump's administration completes a review of the drug's safety.
U.S. District Judge Reed O'Connor in Fort Worth, Texas, said on Monday that because the states' Republican attorneys general and the U.S. Food and Drug Administration, which is conducting the review, had agreed to put the case on hold, it was reasonable to do so.
O'Connor also rejected a motion by drugmakers GenBioPro and Danco Laboratories, which make mifepristone and have intervened in the lawsuit, to dismiss the case. The judge, an appointee of Republican President George W. Bush, paused the lawsuit until the earlier of December 1 or when the FDA completes its review.
Challenge to FDA approval and access rules
The lawsuit filed last December challenges the FDA's initial 2000 approval of mifepristone and regulations adopted under Democratic Presidents Barack Obama and Joe Biden expanding access to the drug, including a 2023 rule allowing mifepristone to be dispensed through the mail. A judge in April put on hold a separate lawsuit by the state of Louisiana challenging that regulation.
The offices of Texas Attorney General Ken Paxton and Florida Attorney General James Uthmeier did not immediately respond to requests for comment on Tuesday.
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