Lawsuit alleges that the FDA should not have used an accelerated review process for mifepristone
By Physician’s Briefing Staff HealthDay Reporter
MONDAY, Feb. 13, 2023 (HealthDay News) — Access to medication abortion could be at risk nationwide because of a Texas lawsuit working its way through the court system. Alliance Defending Freedom, the group involved in the case in Mississippi that led to the Supreme Court overturning the landmark Roe v. Wade ruling, also filed this lawsuit.
The case will be decided by U.S. District Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump. If the judge sides with the organization filing suit, the drug mifepristone, approved by the U.S. Food and Drug Administration nearly two decades ago, could become unavailable both in states that ban abortions and those where it is legal, CBS News reported.
The judge’s decision could also remove easier access that has been implemented more recently, including the 2021 FDA decision not requiring women to pick up the drug in person and a 2023 decision that allowed pharmacies to dispense the drug. The decision could come soon after a Feb. 24 filing deadline and would likely be appealed, CBS News reported.
The group’s allegation is that the FDA should not have used an accelerated review process for mifepristone, CBS News reported.
“Our representatives in Congress created the FDA and gave the FDA the responsibility to make sure that drugs are safe before they’re allowed on the market … the FDA failed that responsibility,” said Julie Blake, senior counsel for the group. The FDA has responded that it did not accelerate the drug’s approval, rather that it approved it four years after the manufacturer applied, CBS News reported.
It would be “extraordinary and unprecedented” to stop distribution of the drug after so long, federal attorneys said in a legal filing.
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