The Package Insert (PI) is a Food and Drug Administration (FDA) regulated document included in the package of a medication that has technical guidance and information about the drug and its use. The PI is designed for medical professionals. The Pharmaceutical Information Modernization Act of 2025 (H.R. 4132/S. 2027) would allow the FDA to finalize a proposed rule permitting drug manufacturers to send prescribing information electronically, instead of on printed paper. 

The existing system of printed PIs offers unbiased scientific information throughout the entire drug supply chain. Although not written for patients, the Package Insert is the primary source, sometimes through republication, of reliable, scientific information for healthcare professionals as learned intermediaries to patients, or for the involved patients who ask for and read the PIs themselves.

Printed PIs should be readily accessible to medical professionals, patients, and caregivers. Electronic distribution should not be a replacement for printed medication information. 

We need your help in letting Congress know that printed Package Inserts should be the default, instead of e-delivery. Take action by urging your representatives to vote NO to the Pharmaceutical Information Modernization Act of 2025.