The Alliance Defending Freedom (ADF) is acting on behalf of four national medical associations, their members, and four physicians in a case against the FDA. The lawsuit alleges that the FDA has "unlawfully removed crucial safety standards for pregnant women who use the abortion drugs mifepristone and misoprostol."
According to the ADF, the FDA has gradually eliminated "nearly all" of its mandatory safety standards over the past eight years, which were designed to "ensure women and girls had ongoing medical care while taking these high-risk drugs."
These protective measures included an initial in-person consultation to screen for severe conditions such as ectopic pregnancies, as well as subsequent visits to monitor for complications like infections or internal bleeding.
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Legal representatives for the case assert in a court document that the FDA began dismantling most of these safety requirements in 2016, "without any study evaluating the changes under the new conditions of use and without a reasonable explanation."
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The court document further argues that the FDA's 2021 decision to eliminate the initial in-person consultation was "arbitrary and capricious," and that the 2016 decision, which removed two of three office visits among other things, "fares no better."
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"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."
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The ADF contends that "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." They further argue that the FDA made these "reckless actions" while acknowledging that approximately one in 25 women who take these drugs will end up in the emergency room.
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The case was escalated to the Supreme Court after the US Court of Appeals for the 5th Circuit ruled that the FDA had acted unlawfully.
Erin Hawley, Senior Counsel for the Alliance Defending Freedom, who will be arguing the case before the Supreme Court, stated, "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."
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She added, "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."
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