Originally Published PMPN October 2002
NEWS
PhRMA Supports Electronic Labeling
The primary trade association for pharmaceutical manufacturers has endorsed a proposed FDA rule that would require firms to submit electronic copies of their products' professional labeling to the agency. The agency says this would make it easier to evaluate any changes to labeling.
Pharmaceutical Research and Manufacturers of America (PhRMA; Washington, DC) said in a letter dated August 1, 2002, that it supports the proposal for that reason, but also because it is integral for the dissemination of paperless prescribing information (PI). The association is beginning to test systems that would allow physicians and pharmacists to view labeling electronically, enabling them to become aware of labeling changes as soon as they are made.
"PhRMA believes that the printed PI is becoming an anachronism," the letter continues. "New computer technologies allow for the storage and dissemination of electronic versions of the drug label . . . By re-quiring the submission of this information in an electronic format, FDA will be able to establish a current database of PI for all prescription drugs. This will permit vendors to develop solutions for delivering such information to sites that dispense Rx pharmaceuticals."
The Pharmaceutical Printed Literature Association (PPLA; Falls Church, VA), an association for suppliers of paper inserts, also sent a letter to FDA endorsing the proposal. However, PPLA urged that the proposal not lead to electronic PIs, citing potential "problems ranging from guaranteeing constant, never-ending access to an electronic system for all dispensing sites to more frightening scenarios such as power failures, hackers, and/or terrorist attacks." It asked the agency to not allow the commercial release of any data submitted to it electronically.
PhRMA encouraged FDA to use an electronic format to communicate proposed labeling changes to industry. The organization also urged FDA to "use appropriate metrics to track the anticipated gains that are associated with the electronic submission and review of labeling."
The association cautioned, however, that agency employees will need to be appropriately trained on any version-comparison system it may use. PhRMA also felt that the agency's estimate that firms will only need 15 minutes to complete the labeling sections in an electronic format is "extremely low." The association also suggested that labeling submitted in a firm's annual report to FDA should not be required to be in an electronic format, since the rest of the annual report is still required to be on paper.
Copyright ©2002 Pharmaceutical & Medical Packaging News
