GPhA and PhRMA push for alternative to FDA generic drug labeling proposal

The USA’s Generic Pharmaceutical Association (GPhA) has submitted new comments on the Food and Drug Administration’s Proposed Rule to update generic drug labeling requirements, urging the agency to adopt the joint alternative proposal known as the Expedited Agency Review (EAR), that it has put forward with the Pharmaceutical Research and Manufacturers of America (PhRMA).

Additionally, supply chain participants, minority health groups and others signed letters to the agency supporting the EAR and raising patient safety concerns with the Proposed Rule as drafted.

“GPhA shares the FDA goals to promote and protect public health,” said Ralph Neas, president and chief executive of the GPhA, adding: “However, the Proposed Rule creates a scenario where disparate and potentially conflicting information from multiple manufacturers for single medicines could be widespread, causing confusion and putting patient safety, access and savings at risk.