Despite modernization across almost every aspect of healthcare, pharmaceutical companies are still required to send prescribing information (PI) to pharmacists and physicians in paper form. This paper, which averages 30-pages1 per PI insert and totals hundreds of billions of pages printed annually, is an inefficient means of providing important safety information. Paper PI is often already outdated by the time it reaches a pharmacy or physician’s office, as it takes on average 8-12 months to develop, implement, print, process, and deliver PI through the supply chain. With updates to PI happening regularly, this time lag can contribute to conflicting or confusing information for prescribers. As a result, this antiquated policy causes the unnecessary – and potentially dangerous – destruction and waste of 4.8 million trees each year.
In 2014, the Food and Drug Administration (FDA) proposed modernizing this policy by allowing pharmaceutical manufacturers to eliminate paper waste and increase patient safety by transmitting PI electronically. Unfortunately, Congress has blocked this common-sense reform in its annual appropriations process, prohibiting FDA from using any funds to advance this initiative.
To address this, Representatives Mikie Sherrill (D-NJ) and John Curtis (R-UT) have introduced bipartisan legislation that, if passed, would enable FDA to move forward rulemaking to enable electronic dissemination of prescribing information: HR 7559, the Prescription Information Modernization Act. Click here for the bill text and here for a press release from the bill sponsors.
As a member of the Alliance to Modernize Prescribing Information (AMPI), a multi-stakeholder coalition working to advance regulatory and legislative reforms to facilitate the electronic dissemination of PI, Viatris supports HR 7559 and applauds Representatives Sherrill and Curtis for their leadership on this issue. Click here to read AMPI’s press release on the bill’s introduction and follow @ModernizeRXInfo for regular updates on the bill and other ongoing efforts.
It is essential that FDA be allowed to modernize this outdated policy to ensure PI is available in real time, is reliable, and is environmentally sustainable.
1 Sierra Club & U.S. Food and Drug Administration