Extra-Label Communication Could Foster Novel Switch NDAs – Industry Attorney
This article was originally published in The Pink Sheet Daily
FDA has several avenues to foster more novel Rx-to-OTC switches, including allowing extra-label communications beyond the packaging, similar to dispensing labeling used by a pharmacist, to be part of an approval.
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FDA’s Global Engagement report describes the agency’s actions to protect the international supply chain. Meanwhile, the Advances in FDA’s Safety Program for Marketed Drugs report notes label changes and safety studies mandated under its post-market drug safety program.
Without market exclusivity and a requirement to make generics also subject to consumer access restrictions, drug firms likely will not invest in novel switches, says a switch process veteran and Merck Consumer Care executive.
Commissioner Hamburg says FDA asked for input on a “new paradigm” for nonprescription drug approvals in part because pharmaceutical firms have concerns about whether potential access restrictions imposed on an innovating switch would also apply to generic versions that eventually reach the market.