Elizabeth S. Underwood, PhD

It has been over a decade since FDA first proposed a simple, cost-effective change to how prescription information is distributed to healthcare professionals (HCPs). The rule was straightforward: allow for the electronic distribution of prescribing information that is currently printed and shipped as paper inserts with every prescription medication dispensed.

Environmental and financial costs of paper inserts

Yet, years later, the proposed rule still has not been adopted—the United States healthcare system uses approximately 90 billion sheets of paper per year on paper inserts, which arguably compromises services given by healthcare providers to their patients.

Currently, pharmacists receive extensive paper pamphlets with each prescription, some stretching to the size of a dining room table. These pamphlets for healthcare professionals—not patients—take 8-12 months to produce and ship and often arrive outdated. According to the IQVIA Institute for Human Data Science,

 approximately 3.79 billion prescriptions were dispensed in the US in 2019, and by 2023, this number had grown to 6.7 billion, each of which comes with a pamphlet that spans 30 to 45 pages of paper.

The sheer scale of this paper waste is staggering, and it continues every day, despite broad support from medical professionals and the availability of safer, more efficient alternatives.

The regulation requiring paper prescribing information dates back to 1962. In an era when medical records were handwritten and libraries were the primary source of reference material, paper made sense. Today, it doesn’t. Physicians and pharmacists now access drug information through digital platforms that are constantly updated with the latest clinical data, warnings, and regulatory changes. Relying on physical inserts for this information in 2025 is not only inefficient, but incredibly inefficient and a significant source of paper waste

The Environmental Paper Network’s Paper Calculator

estimates that adopting digital prescription information could save over 1.8 million tons of wood—equivalent to more than 10 million trees—and nearly 11 billion gallons of water each year. Transitioning to electronic prescribing information for HCPs would drastically cut down on paper waste.

This shift would not only accommodate healthcare professionals who prefer digital access but also aligns with current environmental goals and enhances efficiency in healthcare communication.

The FDA recognized this in 2014 and proposed a rule to mandate e-labeling of prescribing information (PI) for HCPs. This change would ultimately improve accuracy, allow for more timely updates, provide easier access for providers, and lower costs for manufacturers by eliminating the need to print and ship large documents.

The financial implications of this regulatory stagnation are significant. Printing, packaging, and distributing paper inserts at this scale is not cheap. It consumes administrative resources, increases manufacturing overhead, and adds logistical burden across the supply chain. In an era where every federal dollar is scrutinized and healthcare costs continue to rise, this is the kind of outdated requirement that deserves real attention.

90 billion sheets of paper are used annually in prescription labeling.

and take 8–12 months to print and ship.

Transitioning to e-labeling could save 10 million trees and 11 billion gallons of water yearly.

In 2023, 6.7 billion prescriptions were dispensed in the US, each with a paper pamphlet.

Bipartisan legislation to authorize FDA action

However, there is now a bipartisan solution on the table to fix this. This June, Rep. Diana Harshbarger (R-TN), a former pharmacist, and Rep. Mikie Sherrill (D-NJ) reintroduced the Prescription Information Modernization Act of 2025

 in the House. This bill complements legislation introduced in the Senate by Sen. Markwayne Mullin (R-OK) and Sen. Cory Booker (D-NJ).

This legislation would give the FDA the explicit authority it needs to finalize its long-delayed e-labeling rule, bringing prescription information into the digital age. For the first time, Congress would be authorizing the FDA to modernize how prescribing data is delivered, clearing the regulatory and legal ambiguity that has stalled progress for more than a decade.

Benefits of e-labeling for healthcare professionals and patients

E-labeling ensures that healthcare professionals always have access to the most current and accurate prescribing data, which is crucial for avoiding drug interactions and improving treatment outcomes. Up-to-date information at clinicians’ fingertips supports faster, better-informed decisions and ultimately leads to improved care delivery.

This bill applies only to healthcare professionals and does not impact patient-facing labels or pharmacy leaflets, maintaining clear boundaries and public access protections. This is a necessary structural shift that unlocks long-promised innovation in how lifesaving drug information is delivered.

Why moving away from paper is critical for a modern healthcare system

The shift to e-labeling is not revolutionary. It is a basic, low-risk, high-reward policy that aligns with how modern healthcare already operates. Hospitals, pharmacies, and clinics across the country are already digital-first. Electronic health records and telehealth services are now standard parts of the healthcare ecosystem.

This isn't just about saving money or eliminating waste—a more aagile regulatory framework would allow the FDA to implement reforms like this without years of gridlock.

In the private sector, outdated processes are routinely retired in favor of faster, more efficient tools, and in my opinion, the US government should be no different, especially when the benefits are so clear and the risks are so minimal.

Congress has the power to act. The FDA has already done the legwork. Medical professionals are ready. Technology is in place. The only thing missing is the political will to bring healthcare regulation into the 21st century.

As we face growing demands on our healthcare infrastructure, policymakers must focus on eliminating inefficiencies and empowering agencies to implement data-driven improvements. The continued requirement for paper prescribing inserts is a case study in how a well-intentioned regulation can become a burden when it fails to evolve.

The path forward is clear. A modern healthcare system should not be reliant on physical paperwork that is expensive, wasteful, redundant, and routinely ignored. We have the tools and the evidence to support a smarter alternative.

Elizabeth S. Underwood, PhD, is the director of the Environmental Paper Network - North America.

1. Haas C. Ending 90 Billion Sheets: The Environmental Impact of Pharmaceutical Paper Waste. Environmental Paper Network. September 28, 2023. 

https://environmentalpaper.org/2023/09/ending-90-billion-sheets-the-environmental-impact-of-pharmaceutical-paper-waste/

2. The Use of Medicines in the U.S. 2023: Usage and Spending Trends and Outlook to 2027. IQVIA Institute for Human Data Science. May 2, 2023. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-use-of-medicines-in-the-us-2023

3. Paper Calculator. Environmental Paper Network. 

4. Rep. Sherrill and Harshbarger Reintroduce Bipartisan Bill to Modernize Prescription Information. Office of US Congresswoman Mikie Sherrill. June 25, 2025. 

https://sherrill.house.gov/media/press-releases/rep-sherrill-and-harshbarger-reintroduce-bipartisan-bill-to-modernize-prescription-information

5. Saraceno N. Modernizing Prescription Information. 

https://www.pharmaceuticalcommerce.com/view/modernizing-prescription-information

Articles

The FDA's proposal to transition from paper to electronic distribution of prescribing information for healthcare professionals remains unimplemented, despite its potential to significantly reduce environmental and financial costs. The U.S. healthcare system currently uses approximately 90 billion sheets of paper annually for prescription inserts, which are often outdated upon arrival. Recent bipartisan legislation aims to empower the FDA to finalize this e-labeling rule, ensuring healthcare professionals have access to the most current prescribing data. This shift aligns with modern digital healthcare practices and could enhance efficiency and care delivery.

New bipartisan legislation would give the FDA authority to modernize prescribing information, reducing waste while improving accuracy and patient care.