5th Circuit reinstates in-person dispensing for mifepristone, prompting Supreme Court stay and industry concerns
The 5th Circuit Court of Appeals reversed a prior ruling and required mifepristone to be dispensed only in person. Danco, the drug's maker, asked the Supreme Court for relief and received a one-week stay, allowing the medication to be mailed and sold in pharmacies again for the short term.
Industry observers say the decision highlights that even medicines with decades of FDA approval can be vulnerable to court orders, creating regulatory uncertainty that could deter investment in new drug development.
The case joins other lawsuits, such as Louisiana v. FDA, that seek to limit or eliminate access to the abortion pill, underscoring the tension between judicial actions and the FDA's science-based approval process.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “Opinion: Mifepristone court ruling makes drug development riskier for everyone”
read at STAT ↗
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