Statement from Ralph G. Neas on the FDA Proposed Rule on E-labeling
WASHINGTON, DC (December 17, 2014) – “The Generic Pharmaceutical Association (GPhA) welcomes the FDA’s proposed rule to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for healthcare professionals.
The proposed rule takes steps to ensure that prescribing information, which is currently delivered to health professionals in paper format, is distributed electronically. This information could include critical details necessary for effective use of the product or timely updates to safety information.
While the information received by patients will not change, e-labeling gives prescribers and dispensers immediate access to the most current, FDA-approved drug prescribing information. This means that manufacturers can provide electronic updates to labels in weeks, rather than the months, or even years, now required for paper labels.
Electronic information sharing removes obsolete drug information in circulation and can reduce prescribing errors. Additionally, the proposed rule is environmentally sustainable and supports savings throughout the drug supply chain by helping to reduce unnecessary storage, shipping, and printing costs that paper labels currently incur.
This streamlined 21st century approach to label information sharing could mark a significant step forward for everyone who relies on updated prescribing information for patients. GPhA looks forward to working with FDA to finalize this rule, strengthen patient safety and improve public health through more effective information exchange.”
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 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.