A lawsuit brought by doctors aims to overturn the Food and Drug Administration's approval of abortion pills, challenging the FDA authority on approving drugs in general.
The federal agency recently enacted a rule change allowing the drug to be dispensed via neighborhood pharmacies. Demand for it has grown on the heels of a Supreme Court ruling overturning the landmark abortion protections of Roe v. Wade.
The Alliance for Hippocratic Medicine sued in federal court in Dallas last year to declare the FDA approval of abortion-causing pills unlawful and removing the pills from sale in the U.S., MSNBC reported.
The FDA approved abortion drug mifepristone more than two decades ago, and when it is used in combination with misoprostol it can terminate a pregnancy up to 10 weeks.
Last summer's overruling of Roe has led some states to impose restrictions on abortion, particularly after a number of weeks, and the sale of mifepristone in the U.S. can run counter to some of these restrictions.
Mifepristone and misoprostol are used in half of the abortions in the U.S.
Judge Matthew Kacsmaryk is hearing the challenge to the FDA's approval of the pill, and was tapped for the bench by former President Donald Trump in 2019.
The case could lead to the ban of the sale of the abortion pills in the U.S. and threatens to weaken FDA approval powers, according to the report.
Kacsmaryk was appointed by former President Donald Trump to the U.S. District Court for the Northern District of Texas in 2019. From there, a Biden administration appeal would go to the 5th Circuit in New Orleans, a conservative court with 12 of 16 active judges appointed by Republicans.
After that, it would be in the hands of the Supreme Court, which Trump appointments turned the court to a 6-3 conservative majority.
Anti-abortion physicians argue in the lawsuit the FDA abused its power by using an accelerated approval process that is reserved for new drugs that save the lives of patients suffering from serious or life-threatening illnesses.
Pregnancy up to 10 weeks is not life-threatening and the mifepristone is not more safe and effective than a surgical abortion, which puts patients' health at risk unnecessarily, the lawyers argue.
The FDA's response argues against the "extraordinary and unprecedented" attempt to unwind an FDA approval leading to a drug being removed from the marketplace. Also, the FDA lawyers say, science and data have shown mifepristone to be a safe and effective way to end an early pregnancy compared to surgical abortion or childbirth.
FDA lawyers also argued public interest would be "dramatically harmed," forcing an overcrowding of surgical abortion locales, MSNBC reported.
"If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions," FDA lawyers argued in the response, according to MSNBC.
Georgetown Law expert Lawrence Gostin told MSNBC it would be "highly irresponsible" and "reckless" for a federal judge to usurp the FDA's approval powers, calling it potentially "disastrous" and "cataclysmic" legal precedent.
"You can't have individual states, let alone a single judge, overturning all of the scientific evidence that's assessed by the federal Food and Drug Administration and usurping that power for itself," Gostin, a Biden administration health policy adviser, told MSNBC.
"It would mean that any FDA regulatory or approval decision could be subject to the whims of a single federal court or state."
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