09 Mar Harshbarger, Sherrill Introduce E-Labeling Legislation
Press Release: Representative Diana Harshbarger
WASHINGTON, DC – Today, U.S. Representative Diana Harshbarger (R-TN), a practicing pharmacist before being elected to Congress, and U.S. Representative Mikie Sherrill (D-NJ) introduced the Prescription Information Modernization Act of 2023. The bipartisan bill will allow the Food and Drug Administration (FDA) to move forward with a proposed rule allowing drug manufacturers to transmit prescribing information electronically, as opposed to a printed copy, as currently required.
“The FDA’s outdated policies lead to unnecessary waste, inefficiencies in our healthcare system, and poorer outcomes for patients,” said Rep. Harshbarger. “Our bill provides a common-sense solution by giving healthcare professionals the option to choose how they receive prescribing information, bringing us into the digital age and ensuring that patients receive the most up-to-date information possible. Thank you to my colleague, Rep. Sherrill, for partnering on this important issue.”
“Common-sense modernization of Prescription Information requirements will improve care by ensuring pharmacists have the most reliable and up-to-date prescription drug information available while reducing waste and preventing environmental damage,” said Rep. Sherrill. “It’s time to get out of the past and allow drug manufacturers to deliver prescribing information to pharmacists digitally. I look forward to moving this bipartisan bill through Congress with my colleague Representative Harshbarger.”
Under the current policy, which has not been updated since 1962, prescribing information sent to providers that contain important information related to a specific drug must be printed, running an average of 45 pages per prescription. This information is not intended for patients but rather contains the drug’s chemical makeup and information that informs a healthcare professional on the drug’s interaction with other drugs. In 2014, the FDA proposed a rule that would allow the electronic distribution of prescribing information. Since then, Congress has used the appropriations process to prevent the agency from finalizing that rule, requiring the bulky paper labels to be printed and distributed, even though many are immediately discarded by healthcare professionals for being outdated.
The Harshbarger-Sherrill legislation would give healthcare professionals the option to choose how they receive prescribing information. In most cases, healthcare professionals choose to receive the information digitally because the information is available in real-time. Printed information takes approximately 8-12 months from printing to shipment, and information is often outdated by the time it reaches the recipient.
In 2022, identical legislation received the support of 31 cosponsors from both parties.
This legislation is being introduced in the 118th Congress with the support of the Alliance to Modernize Prescribing Information (AMPI), the American Pharmacists Association (APhA), and a coalition of stakeholders from across the country.