Statement by Chip Davis, President and CEO, GPHA, Regarding the FDA Proposed Rule on Generic Drug Labels
Contact: Steve Arnoff 202.249.7113
WASHINGTON, DC ( Dec. 3, 2015) - “GPhA is pleased that the Food and Drug Administration (FDA) will continue to evaluate the wide range of concerns expressed over the currently proposed changes to generic drug labeling requirements. GPhA continues to support the Expedited Agency Review (EAR), a better way forward that strengthens the communication of drug safety information without putting patients at risk.
Current law requires brands and generics to carry the same label to assure healthcare practitioners have consistent information to inform their decisions and patient conversations. The proposed rule would change this by requiring generic manufacturers to update labels based on incomplete information without first receiving FDA approval. However, no single manufacturer has access to the full range of available data — the proprietary data from clinical studies or the data held by each individual applicant holder.
The FDA is the only entity with all of the data needed to recommend a safety information change. Instead, the EAR suggests time parameters for the FDA to take action and encourages the adoption of e-labeling for real time information sharing rather than continuing the reliance on paper label changes that take months or years to adopt. The EAR also takes important steps to make sure that multiple different labels do not exist for products with the same active ingredients, safety and efficacy.
GPhA will continue to work with the Agency and other stakeholders committed to advancing and protecting patient health to ensure that any changes to labeling regulations do not put patient safety at risk and avoid causing provider confusion.”
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.