This Act modernizes drug information delivery by allowing manufacturers to provide FDA-approved prescribing information digitally, while ensuring healthcare providers can still easily opt for paper copies.
Markwayne Mullin
Senator
OK
The Prescription Information Modernization Act of 2025 allows drug manufacturers to provide required prescribing information to doctors and pharmacists digitally, rather than solely on paper. Healthcare providers retain the right to opt-in to receive paper copies upon request, free of charge. The Secretary of HHS must establish final rules within one year to implement this transition, ensuring accessibility and provider choice.
The newly proposed Prescription Information Modernization Act of 2025 is looking to drag pharmaceutical documentation out of the paper age and into the digital one. Essentially, this bill lets drug manufacturers stop automatically shipping massive stacks of prescribing information (the detailed instructions, warnings, and dosage info) with every batch of medication. Instead, they can provide this crucial data exclusively through electronic means, like a website or digital file.
This isn't just about saving trees; it’s a major shift in how critical health information gets delivered. Under Section 2 of the Act, manufacturers are now allowed to go digital-only. But here’s the crucial catch: doctors and pharmacists must still be given the option to opt-in to receive paper copies, or request them whenever needed. If they ask for paper after the switch, the manufacturer has to send it “quickly” and cannot charge a dime for it. The Department of Health and Human Services (HHS) has one year to figure out the exact rules for how this opt-in system works, and the whole thing kicks off two years after the bill passes, or once those rules are finalized.
For the pharmaceutical industry, this is a win. Printing and shipping millions of pages of detailed, often updated, prescribing information is expensive and cumbersome. Switching to digital cuts down on administrative costs and paper waste. For a large hospital system with state-of-the-art digital infrastructure, having instant, searchable access to the latest drug data online is probably a huge benefit.
But for the small, independent pharmacy or the rural clinic, this bill introduces administrative friction. Think about your local pharmacist who might prefer having that physical binder of drug inserts handy for quick reference, especially during a busy shift or if the internet connection is spotty. They now have to proactively manage an opt-in system across potentially dozens of different drug manufacturers. If they forget to opt-in, or if the manufacturer makes the process clunky, they have to wait for the paper copy to be mailed whenever they need a deep dive into the prescribing data. The bill requires the copy to be sent “quickly,” but that word isn't defined, which leaves a lot of wiggle room for delays.
While the intent is modernization, the risk lies in accessibility. This bill shifts the default expectation from paper (always there) to digital (you have to find it). For healthcare providers who are already juggling patient care, insurance forms, and staffing issues, adding another administrative layer—managing digital portals and paper copy requests—is a burden. The bill tries to mitigate this by requiring a public meeting within two years to discuss how to keep the digital information “easy to find, use, and read.” That’s a good step, but it happens after the system is already in place.
Ultimately, this change is about efficiency, but efficiency for the manufacturer might translate into a slight headache for the healthcare provider. While the digital format offers speed and searchability, the bill’s success hinges entirely on HHS creating strong rules that make the paper opt-out process genuinely easy and ensure that “quickly” means within hours, not days, when a provider needs critical information to safely dispense a drug.