Listen to this article Manufacturer Of Abortion Pill Files Lawsuit Against FDA In Order To Maintain Drug’s Availability On The Market
Introduction
The manufacturer GenBioPro, which produces the generic version of the widely used abortion pill mifepristone, has taken legal action against the Food and Drug Administration (FDA) to prevent the removal of the drug from the market. The Supreme Court is expected to decide on the same day whether to impose restrictions on the medication, which could potentially include revoking the FDA’s authorization of the generic form.
Background
The US 5th Circuit Court of Appeals recently ruled that the FDA’s 2000 approval of mifepristone, given to brand-name manufacturer Danco Laboratories, could remain. However, it reimposed limitations on the drug that the FDA had removed over the years, which had increased access to the pill. The Supreme Court temporarily blocked that ruling, but the stay is set to expire today at 11:59 p.m. If the Supreme Court does not act by then, the restored restrictions, including the stay on GenBioPro’s 2019 FDA approval, would take effect.
GenBioPro’s Lawsuit
GenBioPro filed the lawsuit to prevent the FDA from depriving the company of its constitutional and statutory right to market mifepristone. The company is seeking an order requiring the FDA to keep its mifepristone on the market. The lawsuit argues that the FDA has not provided any guidance on what the company must do if federal court rulings staying the agency’s authorization of the drug take effect, which, it claims, will result in chaos.
Moreover, the suit aims to prevent the Biden administration from taking enforcement actions against the company, its agents, manufacturers, distributors, partners, and customers, which would upend nearly a quarter-century of public reliance on a safe and effective drug.
Impact on Medication Abortion
GenBioPro supplies around two-thirds of the medication abortion pills used in the United States. If the Supreme Court does not act before the stay expires, the reinstated restrictions would take effect, including the stay on GenBioPro’s 2019 FDA approval. The restriction could significantly reduce the accessibility of medication abortion, especially in states with only one abortion clinic, as some states have already limited access to the pill.
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