Manatt Health Partner Rachel Sher was quoted in Pink Sheet about the recent lawsuits challenging the Food and Drug Administration’s (FDA) authority to approve and regulate drugs, specifically the medication abortion drug mifepristone, and how they may undermine FDA’s statutory and regulatory framework for drug approvals. “These cases pose unprecedented challenges to FDA’s approval authority and scientific judgment. Courts have not previously second-guessed FDA’s decisions based on their own assessments of a drug’s safety and effectiveness,” Sher said. “All Americans, at one time or another, have taken FDA-approved medications; FDA’s premarket review and approval process set the ‘gold standard’ for the rest of the world. So these challenges should deeply concern everyone,” noted Sher.
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