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The 5th U.S. Circuit Court of Appeals in New Orleans has criticized the U.S. Food and Drug Administration (FDA) for failing to address safety concerns related to the expansion of access to the abortion drug mifepristone in 2016 and 2021. The court’s decision has ignited a legal debate over the drug’s accessibility and regulations.
The 5th Circuit argued that the FDA’s expansion of mifepristone access should be reversed, effectively reinstating the restrictions that were in place prior to 2016. However, due to a prior order by the U.S. Supreme Court, the drug will remain accessible under the current regulations, pending further decisions by the high court. This development has been reported by reputable sources such as the Washington Post, New York Times, and Reuters.
Central to the controversy are FDA decisions that enabled nonphysicians to prescribe mifepristone, allowed remote prescription of the drug, and permitted the drug to be mailed to users. Various parties have challenged these decisions, including the Alliance for Hippocratic Medicine, several doctors, and similar organizations.
See also: Iowa Abortion Ban Temporarily Halted by Judge Amid Ongoing Lawsuit by Providers
The doctors who opposed these FDA decisions argued that they were ethically obligated to perform abortions or support the process when complications arose from mifepristone usage, a practice that contradicted their moral beliefs.
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The changes made by the FDA in 2016 included expanding eligibility for mifepristone to pregnancies with a gestational age of up to 70 days, up from the previous limit of 49 days. The agency also authorized nonphysicians to prescribe the drug, eliminated the need for in-person administration and follow-up, removed the requirement to report non-fatal adverse events, and modified the dosage. In 2021, the FDA made an additional change by allowing mifepristone to be prescribed remotely and sent via mail.
In an opinion written by Judge Jennifer Walker Elrod, an appointee of former President George W. Bush, the 5th Circuit’s decision partially upheld a ruling by U.S. District Judge Matthew J. Kacsmaryk of the Northern District of Texas. Judge Elrod contended that it was too late to challenge the initial FDA approval of mifepristone and that the doctors had not demonstrated harm resulting from the approval of a generic version of the drug in 2019. However, she sided with the challengers in their opposition to the 2016 and 2021 changes.
Judge Elrod criticized the FDA for assessing the impact of the 2016 changes individually without considering their cumulative effect. She also faulted the agency for failing to take into account the loosening of restrictions on the drug’s use when deciding not to collect data on nonfatal adverse events due to its perceived low-risk profile. Furthermore, she found fault with the limited data on which the FDA’s 2021 decision was based.
Judge Elrod clarified that the evidence did not universally establish mifepristone as unsafe but acknowledged that the plaintiffs had presented substantial evidence that the changes made in 2016 and 2021 were implemented without adequate consideration of their effects on patients.
Judge James C. Ho, in a partial concurrence, aligned with the view that the 2016 and 2021 changes were arbitrary and capricious, therefore necessitating their nullification. Additionally, he contended that the 2021 change contravened the Comstock Act, a law that criminalizes the mailing of abortion drugs. Judge Ho also expressed support for invalidating the initial approval of mifepristone.
This decision by the 5th Circuit has set the stage for a continuing legal battle over mifepristone’s accessibility and FDA regulations. With the potential involvement of the U.S. Supreme Court, the debate surrounding reproductive rights and drug regulations is likely to remain in the forefront of legal discussions.
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