July 18, 2024

US Supreme Court considers impact on FDA in abortion pill case


The US Supreme Court is set to hear a significant case regarding the availability of abortion pills, with potential repercussions for the authority of the federal Food and Drug Administration (FDA). If the Court decides to limit access to these pills, it could undermine the FDA’s scientific credibility in unprecedented ways, experts caution.

The case revolves around mifepristone, the first of two pills used in medication abortions. While the focus is narrow, a broad ruling could jeopardize access to various drugs for different conditions, according to experts interviewed by AFP. Mifepristone, authorized by the FDA in 2000, is utilized in almost two-thirds of all abortions in the US and is considered safe and legal in numerous other countries.

In 2016, the FDA eased restrictions on mifepristone, extending its prescription window and permitting a wider range of healthcare professionals to prescribe it. Additionally, amidst the COVID-19 pandemic, the FDA allowed the pills to be distributed via mail after a single online consultation. However, a group of anti-abortion advocates challenged this, alleging safety concerns and flaws in the approval process. Last year, an appeals court sided with them, reverting the FDA’s regulations to pre-2016 standards.

Legal experts emphasize the unprecedented nature of the Supreme Court’s potential intervention in scientific matters traditionally under the FDA’s purview. While courts have questioned FDA decisions in the past, imposing restrictions based on disagreements with scientific experts would set a concerning precedent, they argue.

The pharmaceutical industry also opposes judicial interference, warning of heightened uncertainty in the drug approval process. Confirming the appeals court’s decision could stifle innovation and potentially lead to drugmakers suing the FDA to block competitor medications.

Furthermore, the Court’s involvement in regulatory matters extends beyond the abortion pill case, potentially undermining various agency decisions on scientific assessments. With recent conservative shifts in the Court’s composition and decisions, there is apprehension about the outcome, especially considering the 2022 ruling that devolved abortion rights regulation to individual states.

Ultimately, the Court’s ruling, expected by summer, holds significant implications for both abortion access and the broader regulatory framework surrounding FDA decisions, sparking debates about the appropriate balance between judicial oversight and scientific expertise.

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