Patient Safety and Drug Labeling Improvement Act

Mr. Speaker, the Patient Safety and Drug Labeling Improvement Act is meant to address a troubling inconsistency in the law, created by Pliva v. Mensing, which does not allow consumers injured by generic drugs to hold the manufacturer accountable for inadequate warnings.

The Mensing ruling also eliminates any incentive for generic drug manufacturers to monitor the safety of the products they sell and propose necessary changes to labeling to the FDA, as currently required by federal law.

Under the Patient Safety and Drug Labeling Improvement Act manufacturers of generic drugs assume the same duties as brand manufacturers to monitor the safety of the drugs they sell and to ensure that their labeling contains accurate risk information. More specifically, the legislation authorizes generic drug manufacturers to independently initiate labeling changes through the Changes Being Effected (CBE) process under the same circumstances that apply to manufacturers of branded drugs in order to ensure that all drug labels accurately reflect current health and safety information.