Faith Monahan ’24
Two conflicting opinions over the FDA’s regulation of the medication Mifepristone were issued last Friday. The medication is commonly known as the “abortion pill.” Mifepristone is one of the two pills taken together in medical abortions. Texas Judge Matthew J. Kacsmaryk ruled to reverse the FDA’s approval of the drug completely. The ruling, if it goes into effect, would impact access across the entire United States, even in states where abortion is legal. The FDA approved mifepristone over 20 years ago, making the Texas ruling an unprecedented measure in judicial interference of drug regulations. In another lawsuit in Washington state, Judge Thomas Rice ruled in favor of preventing the FDA from making changes in regulations that would restrict access to mifepristone in 17 states where abortion is legal. The White House quickly released a statement declaring that the Biden Administration would appeal and fight the lawsuit in Texas against the FDA. Abortion providers are expected to continue to prescribe mifepristone in Texas unless the FDA provides specific instructions against prescriptions.
The Alliance Defending Freedom, a conservative Christian organization, represented the plaintiffs, the Alliance for Hippocratic Medicine, for the case in Texas. The five doctors in the lawsuit claimed to have suffered harm from treating incomplete medical abortions which opposed their moral views. An incomplete medical abortion following medication requires a surgical procedure to prevent sepsis or other health complications. Judge Kacsmaryk, a Trump appointee, sided with the plaintiffs. The opinion states that the FDA’s approval of mifepristone over twenty years ago was made without legitimate consideration for safety concerns. Studies conducted by the National Institutes of Health have found that the two-part regimen for medical abortions, mifepristone and misoprostol, are 97.7% effective. The FDA cited similar studies and argued in the case that less than 1% of patients seeking medical abortions require hospitalization.
The Biden Administration filed an appeal to the 5th Circuit Court shortly after the opinion was handed down in Texas. A stay of the decision would block any reversal of FDA approval’s of mifepristone and keep the medication available in the United States while the case is heard by the 5th Circuit. Mifeprestone is expected to stay available in states where the drug is legal while the case is being appealed.The Washington Post has reported that abortion clinics will not stop prescribing mifepristone until the FDA provides specific instructions on stopping prescriptions. Without medicated abortions, patients will have no medical alternative to surgical procedures. There is also evidence supporting the use of misoprostol alone to induce medical abortions, although that regimen would result in a slightly lower efficiency rate of 95%.
A competing opinion to the Texas ruling was given in Washington state on Friday. Seventeen attorney generals from Democratic-led states had filed the lawsuit claiming that the FDA’s regulation on mifepristone were too restrictive. Judge Rice, an Obama appointee, made a more limited ruling ordering the FDA to not increase restrictions on mifepristone in the 17 states involved in the lawsuit and that the FDA should maintain the current “status quo.”