Yesterday, U.S. Senators Markwayne Mullin (R-OK) and Cory Booker (D-NJ) reintroduced the “Prescription Information Modernization Act of 2025.” You’ll likely remember that it has had quite a history. It’s a commonsense bill that would allow firms to use electronic labeling, eliminating the requirement to include paper package inserts, better known as the prescribing information, while also saving hundreds of thousands of trees each year. For years, the pharmaceutical industry has been trying to make the conversion from paper package inserts to electronic labeling. The Senators conclude that “[t]his bill will enable the Food and Drug Administration (FDA) to implement a rule that allows drug manufacturers to share prescribing information electronically in order to reduce waste, improve efficiency, and ensure that healthcare professionals have access to the latest drug information” (see Senator Mullin’s press release on the reintroduced bill here).
In 2021, Jane Axelrad wrote an article in STAT (here) that outlined the problem with the continued use of paper to provide prescription labeling to healthcare providers and patients. One of the points she made, which is very relevant today, is that since drug products have expiration dates of two to five years, the information in the paper versions accompanying drug products may be considerably out of date and may not have current safety information. The use of electronic labeling can ensure that patients and practitioners have instant access to the most up-to-date information at the touch of a button.
However, according to Alexrad, “[i]n every appropriations bill since 2015, Congress has forbidden the FDA from using any funds to allow or require prescribing information to be distributed in electronic form instead of paper, and these provisions prevent the FDA from proposing to bring prescribing information into the modern digital era.”
Well, here’s another bite at the apple to move prescription labeling into the modern era. Let’s hope that this year Congress will not only pass the bill but also permit funding for implementation of the bill. The time is certainly right, and well overdue, for such a change.
