As the world moves rapidly to greater digitization, the federal government remains mired in paperwork.  Some of the requirements are decades old, including a 1962 rule that requires drug manufacturers to transmit prescribing information to healthcare providers on a paper label, which uses 90 billion sheets of paper annually.  Modernizing this rule would fit President Trump’s call for “common sense” in government, but it has not yet been done. 

The Government Accountability Office (GAO) released a report in July 2013 about moving to electronic transmittal, which range from one page to more than 100 pages.  GAO noted that, “Revisions can often be made to drug labeling as more data about the drug become available from its wider use by patients, according to FDA officials.  In calendar year 2010, FDA reported 747 changes to drug labeling; this number increased to 975 in calendar year 2011 and to 1,357 in calendar year 2012.  Because it takes time to print new labeling and incorporate it into new drug packaging, some drugs that have already been shipped to their distribution points might be on the market with labeling that is out of date.”

In 2014, the Food and Drug Administration (FDA) proposed changing the rules to allow prescription drug and biological product labeling to be distributed electronically, and that prescribing information intended for healthcare professionals no longer be permitted to be distributed in paper form with the package, expect as required under regulations.  But Congress has blocked the FDA from implementing the rule through a provision in annual appropriations legislation. 

In addition to saving money and increasing efficiency, changing the rule would increase patient safety.  A May 21, 2021 letter from Reps. Mikie Sherrill (D-N.J.) and Adam Kinzinger (R-Ill.) asked the House Appropriations Committee to allow “pharmaceutical prescribing information (PI) to be delivered in digital form instead of paper.”   The members noted that “Electronic PI allows prescribers easy access to the most up-to-date product information available through a digital platform.  Product information is frequently updated, requiring numerous label changes for crucial dosing information, particularly with new therapies to reflect emerging medical and safety information, which can take 8-12 months for these changes to be reflected in paper-based information.”

In the 118th Congress, the Prescription Modernization Act was introduced as H.R. 1503 in the House of Representatives and S. 2916 in the Senate.  These bills would have allowed health care providers to receive this information electronically instead of requiring the paper format from manufacturers, while still allowing pharmacists to receive this information on paper if they so choose, but they were not voted out of any committee.

The failure to modernize this 63-year-old government mandate is putting patients at risk and standing in the way of more efficient healthcare delivery.  It has not occurred for the same reason other commonsense proposals fail:  The protection of a special interest.  It is long past time for Congress and the FDA to stop pharmacists and physicians from drowning in paper.