In our June 25,2025 blog post (here), we expressed hope that drug prescribing paper inserts might give way to electronic labeling:
“On June 25, 2025, Reps. Sherrill and Harshbarger reintroduced a bipartisan bill to modernize prescription information (here) and, on June 12, 2025, two senators introduced a similar bill in the Senate (see previous post here). Now we have very similar bills floating around in each chamber. Maybe this is the year that the legislation will pass and Congress will provide for the use of appropriate funds by the FDA to make the change in the way prescribing information is provided to the public.”
Well, the recent appropriations bill (Public Law No. 119-37) once again killed the electronic labeling initiative, at least for fiscal year 2026. Similar language that had appeared in previous appropriation bills appears again in the new bill, precluding the use of any government funds to move this labeling initiative forward. The one sentence, appearing in thousands of pages of the legislation, that will further delay the ability to quickly revise and update innovator and generic labeling so that healthcare providers and patients can be assured that they have the most current and up-to-date prescribing information appears below:
“Sec. 722. None of the funds made available by this Act may be used to propose, promulgate, or implement any rule, or take any other action with respect to, allowing or requiring information intended for a prescribing health care professional, in the case of a drug or biological product subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)), to be distributed to such professional electronically (in lieu of in paper form) unless and until a Federal law is enacted to allow or require such distribution.”
So, what is Congress waiting for? Good question! The FDA Group’s Insider Newsletter (here, subscription required) states:
“Insider Critics including the Alliance to Modernize Prescribing Information argue the ban results in outdated medical information and waste of 90 billion pages annually, while supporters emphasize ensuring ready availability of prescription information.”
It looks like the paper lobby won again with its argument that having a paper copy makes information more readily available to patients. If you want patients and healthcare providers to have the most accurate approved information for prescription drugs, electronic labeling allows revised or newly added information to be available immediately. Maybe the initiative will go through next year?
