The FDA Neglected Women’s Welfare in Abortion Drug Procedures

 

Yesterday, the federal court in Alliance for Hippocratic Medicine v. FDA held against the FDA’s removal of abortion drug protections for women on several levels. 

“In loosening mifepristone’s safety restrictions, the FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the court wrote in its opinion, adding that the FDA “failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

The 5th U.S. Circuit Court of Appeals decision issued yesterday requires the FDA to restore the safeguards it recently removed on the dangerous abortion pill that has killed dozens of women and injured thousands. And the court’s language seemed to scold the potential exploitation of women’s health by deceptive processes. Concerning the 2021 decision to allow mail-order abortion, the court criticized the FDA for giving dispositive weight to their adverse-event data after eliminating the provider-reporting requirement, noting that “it’s unreasonable for an agency to eliminate the reporting requirement for a thing and then use the resulting absence of data to support its decision.” WOW.  Unreasonable and wrong for the health of women and girls. The court further noted that the data the FDA cited in its 2000 approval of mifepristone shows “that thousands of women, and as many as hundreds of thousands, have experienced serious adverse effects as a result of taking the drug, and required surgery or emergency care to treat those effects.” Holding providers of these drugs, as well as the FDA, legally liable is a worthy consideration for any woman or girl who has suffered from using these drugs.   

The decision also found that the FDA must restore critical safeguards for chemical abortion drugs, condemning the improper FDA approval process for the drug mifepristone. This ruling effectively bars mail-order abortion by prohibiting abortion businesses from sending chemical abortion drugs through the mail, something the FDA has been allowing since 2021 in direct violation of longstanding federal law. While the ruling will be appealed to the Supreme Court, if upheld, it will curtail the mail-order abortion business.

Finally, and very significantly, in 2016 the FDA extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs (from seven to 10 weeks’ gestation), removed two of three required office visits, allowed non-doctors to prescribe the drug regimen, and eliminated the requirement that providers report non-fatal adverse events to the FDA Adverse Event Reporting System (FAERS). The 5th Circuit held that the FDA’s 2016 action violated the Administrative Procedure Act and upheld the district court’s conclusion reinstating the original 2000 safeguards, including the seven weeks’ gestational limitation, necessary office visits, non-fatal adverse event reporting, and physician dispensation. 

This decision rightly requires the FDA to end the exploitation of women by abortion drugs and start protecting women instead; and as Alliance Defending Freedom Senior Counsel and Regent Law Professor Erin Hawley stated, to “restore crucial safeguards for women and girls.”

The FDA’s neglect and exploitation of women by abortion drugs must end.