A Texas federal judge will rule on a lawsuit that seeks to reverse the Food and Drug Administration’s (FDA) approval of mifepristone. Mifepristone is one of two drugs commonly prescribed by doctors to induce a medical abortion.
More than half of abortions in the U.S. use mifepristone. A reversal in FDA approval would remove the drug from the market, jeopardizing abortion access for nearly 40 million potentially pregnant patients in America. The ruling of this lawsuit is a significant step that could restrict abortions, even for pregnant people in states with broad abortion access.
The drug is also frequently used to treat miscarriages.
U.S. District Judge Matthew Kacsmaryk, a conservative Trump appointee, is set to rule on the case.
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Attorneys for the American Medical Association have argued that the drug is heavily regulated by the FDA and carries the same risk as ibuprofen.
The FDA calls mifepristone “safe and effective” and said the approval was granted after years of thorough research.
“The FDA approved Mifeprex (the generic version of mifepristone) more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use,” the FDA says on its website.
The drug can be ordered via online pharmacies, complicating abortion access in states where procedures are now illegal.
The Alliance for Hippocratic medicine initially filed the lawsuit, alleging the FDA did not properly vet the drug for health concerns.
Senior counsel for the Alliance Defending Freedom, Julie Marie Blake, said her organization is “confident that when any court looks at the law and looks at the science, it will realize that the FDA has completely failed its responsibility to protect women and girls.”
The lawsuit does not threaten to inhibit misoprostol, another abortion pill. Misoprostol is a two-pill regimen that has slightly lower efficacy than mifepristone.
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