Zohydro v. Massachusetts = Wyeth v. Levine? State Asserts Power To Seek Label Change
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Zohydro Court Win: Deep Splash, But Few Ripples
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.
Supreme Court’s Wyeth v. Levine Ruling Returns Industry To Status Quo On Pre-Emption
The court finds that FDA-approved labeling does not pre-empt individuals from bringing product liability suits under state law.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.