This act allows drug manufacturers to provide required prescribing information digitally, provided they maintain an option for healthcare professionals to receive paper copies upon request.
Diana Harshbarger
Representative
TN-1
The Prescription Information Modernization Act of 2025 allows drug manufacturers to provide required prescribing information to healthcare providers digitally. This shift is contingent upon manufacturers offering providers the option to receive paper copies upon request, free of charge. The Secretary of HHS must establish final rules for this digital transition within one year of enactment.
The Prescription Information Modernization Act of 2025 is a straightforward piece of legislation that updates how drug manufacturers communicate with doctors and pharmacists. Essentially, it allows pharmaceutical companies to switch from automatically mailing out thick stacks of paper—the official, FDA-approved prescribing information for drugs and biological products—to providing that information digitally.
Think of this as the drug industry’s move to paperless billing. Right now, every time a new drug hits the market, or an existing drug gets a label change, manufacturers have to send out physical packets of information (think of the tiny print insert that comes with your meds, but much longer and more detailed) to every prescriber and pharmacy. This bill, under SEC. 2, says manufacturers can now use electronic means—like dedicated websites or digital files—as their primary method of delivery. This is a big win for manufacturers looking to cut down on printing and mailing costs, but it’s not a unilateral switch.
The most important detail for anyone worried about losing access to critical information is the required safety net. Manufacturers can only go digital if they meet two specific conditions. First, they must give doctors and pharmacists the choice to keep receiving paper copies, or they must be able to request a paper copy at any time. Second, if a paper copy is requested, the manufacturer must send it out quickly and without charge. So, if you’re a pharmacist who prefers the physical binder copy for quick reference, you still have the right to get it, and the drug company has to eat the cost and the shipping time. This provision is key for healthcare professionals who might work in areas with poor internet access or who are simply more comfortable with hard copies.
What does this mean for the average person? Indirectly, it’s a modernization effort. If your doctor or pharmacist is comfortable with digital files, this could mean faster access to the most current prescribing information, potentially reducing the chance of them working off an outdated paper copy. However, the bill does create a small potential risk for those who rely on paper. The bill requires manufacturers to send requested paper copies “quickly,” but it doesn't define what “quickly” means. If a manufacturer drags its feet, a doctor or pharmacist needing an immediate reference might face a delay, which could slow down care. The Secretary of Health and Human Services (HHS) has one year to write the final rules defining how this digital system and the paper opt-out process will work, which should hopefully clarify that timeline.
This digital switch doesn't happen tomorrow. The law stipulates that the change won't take effect until two years after enactment, or until the final rules from HHS are in place—whichever is later. This built-in delay gives everyone—from drug companies to rural clinics—plenty of time to prepare for the transition. Furthermore, the bill mandates a public meeting within two years to discuss how to make sure this digital information is actually “easy to find, use, and read.” That’s a crucial step, because simply dumping a PDF online isn't the same as creating a user-friendly, searchable database that a busy doctor can navigate in seconds.