Hatch, Bennet Introduce Bill to Update Outdated Labeling Standards

Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) proposed a bill that would update what they say are outdated drug labeling standards.

The Making Objective Drug Evidence Revisions for New Modern Labeling (MODERN) Act would authorize the FDA to update labeling with new evidence on the drug and its use.

Under the current labeling regulations, the senators noted, sponsors of older brand-name drugs with expired patents have little incentive to update labeling. Such sponsors often withdraw the drug from the market entirely, leaving generics manufacturers with no way of updating the labeling.