Zohydro Court Win: Deep Splash, But Few Ripples
This article was originally published in The Pink Sheet Daily
Declaring that FDA product approval cannot be voided by Massachusetts, federal judge erases what could have been a strong challenge to agency authority; ruling is unlikely to change other state/federal dynamics, however.
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Sixteen US states have issued executive orders or other mandatory directives to preserve hydroxychloroquine and chloroquine for non-COVID-19 patients, while 26 states have issued similar voluntary guidance. The federal government is reserving some of the strategic national stockpile supply of the drugs for non-COVID-19, as private players in the supply chain also join in the efforts to balance on-label use with COVID-related demand.
Arguing for its right to ban Zogenix Inc.’s opioid, Massachusetts contends that FDA clearance of a drug for marketing is a “gateway approval” that does not preempt states from imposing stricter requirements on a product.
Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.