Texas and Florida Sue FDA Not Defending Girls From Harmful Abortion Tablets
Texas and Florida sued the Food and Drug Administration on Tuesday, accusing the agency of failing to properly evaluate the safety of mifepristone, the abortion pill, and disregarding the risks it poses to women.
The lawsuit, filed in federal court in Texas by the states’ Republican attorneys general, challenges the FDA’s 2000 approval of mifepristone as well as its recent decision to greenlight a generic version from Evita Solutions.
The states allege the FDA’s actions were arbitrary and capricious, violating the federal Administrative Procedure Act by prioritizing access over public health.
“These are tragic but predictable consequences of prioritizing politics over public health,” the states said in the complaint, pointing to what they describe as the agency’s neglect of the drug’s dangers.
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Mifepristone, used in combination with misoprostol, is the first step in medication abortions and accounts for more than 60% of babies killed in abortions in the U.S. in the first 10 weeks of pregnancy.
The states argue the FDA has not thoroughly assessed the drug’s safety and effectiveness, particularly after regulatory changes under former Democratic presidents Barack Obama and Joe Biden that expanded access, including allowing prescriptions remotely and delivery by mail. That makes it so doctors are not involved to offer proper oversight and women are left to deal with medical problems by going to the ER.
A recent analysis of commercial insurance claims involving 865,727 mifepristone prescriptions from 2017 to 2023. It found 94,605 women — nearly 11% — suffered serious complications within 45 days, including hemorrhage in 3.31% of cases, emergency room visits in 4.73%, and sepsis in 0.10%.
Peer-reviewed research found three quarters of ER visits within 30 days after abortion drug use were coded as severe or critical. Two separate, independent studies also found more than 1 in 10 women experience at least one severe adverse event. Complications can include hemorrhaging, infection, sepsis, and even death.
Other issues encompassed infections, transfusions, hospitalizations and life-threatening events like cardiac problems or anaphylaxis. In nearly 3% of cases, the drug failed, requiring surgical follow-up. Multiple women have died from the abortion pill.
A large national poll found 7 in 10 voters want to roll back Biden’s mail-order abortion drug rule and reinstate safeguards like in-person doctor visits.
