Alliance Defending Freedom sues Biden's FDA over 'removing key safeguards' to access abortion drugs

The US Supreme Court is set to hear arguments on Tuesday over the alleged removal by the Food and Drug Administration (FDA) of "critical safeguards for the use of chemical abortion drugs."  

Alliance Defending Freedom (ADF) is representing four national medical associations and their members, as well as four doctors against the FDA for "unlawfully removing crucial safety standards for pregnant women who use the abortion drugs mifepristone and misoprostol." 

ADF claims that the FDA has removed "nearly all" of its required safety standards over the past eight years "that ensured women and girls had ongoing medical care while taking these high-risk drugs," ADF wrote. 

These safeguards included an initial in-person visit to screen for serious conditions like ectopic pregnancies, as well as follow-up visits to check for complications like infections or internal bleeding. 

In a court document, attorneys for the case claim that the FDA stripped most of these safety requirements away in 2016, "without any study evaluating the changes under the new conditions of use and without a reasonable explanation." 

The court document states that the FDA’s 2021 decision to remove the initial in-person visit was "arbitrary and capricious," while the 2016 decision that removed two of three office visits, among other things, "fares no better." 

"The 2021 action cannot stand because two admittedly insufficient rationales do not a reasoned decision make," the court document states, later adding that in the 2016 decision, the "FDA failed to consider the cumulative impact of removing all these interrelated safeguards at once." 

"The FDA’s job is to keep people safe, but the agency betrayed women and girls by ending these safety standards and encouraging at-home abortions without ongoing care from a doctor. What’s more, the FDA took these reckless actions while acknowledging that roughly one in 25 women who take these drugs will end up in the emergency room," ADF wrote. 

The case moved to the Supreme Court after the US Court of Appeals for the 5th Circuit ruled that the FDA had acted unlawfully. 

Alliance Defending Freedom Senior Counsel Erin Hawley, who is arguing the case before the Supreme Court, said, "Women should have the ongoing care of a doctor when taking high-risk drugs. The FDA betrayed women and girls when it unlawfully removed the necessary in-person doctor visits that protected women’s health and well-being." 

"The FDA’s own label for abortion drugs says that roughly one in 25 women who take them will end up in the emergency room. Yet the federal government continues to defend its reckless actions that jeopardize women’s health and safety. Women deserve better, and we look forward to advocating on their behalf at the Supreme Court tomorrow."