Author: Bindu Narang, Sciformix Corporation
After extensive industry debate, the US FDA has proposed a new rule to amend its prescription drug and biological product labeling regulations that will take effect in 2015. The rule applies to the electronic distribution of the package insert (PI) which is currently provided in paper form with drug packaging for the benefit of health care professionals (HCPs). When pharmaceutical companies market their products in the US, they will be required to provide the PI in an electronic file and no longer permitted to distribute it in paper form with packages. FDA has proposed an effective date of six months after the publication date of the final rule in the Federal Register and a compliance date of two years after the date of publication of the final rule.
There are many pros and cons regarding the proposed rule, and there are probable benefits to electronic labels reflecting the most up-to-date safety risks and efficacy information. While other literature aimed at patients, including promotional labeling, are excluded from the electronic distribution requirement, opponents argue that many patients still rely on paper PIs to get critical drug information. It is estimated that the proposed rule will save the biopharmaceutical industry between $52 to $164 million annually.