The History of Medication Information on Paper
1938:
The Food, Drug and Cosmetic Act: This act requires that “written, printed, or graphic matter” bearing directions for use and warnings be “upon the immediate container of any article.”
1995
Public Law 104-80: This law gave the pharmaceutical supply chain an opportunity to demonstrate that it could provide useful Consumer Medication Information (CMI) at the time prescriptions were filled.
1998
The Prescription Drug Marketing Act: The notable feature of this law was its requirement that Patient Package Inserts (PPIs) be prepared for all drugs that are marketed directly to consumers.
2000
FDA issues draft regulation on Package Inserts (PIs): These require a “Highlights” section and other features intended to improve readability/usefulness for healthcare professionals.
2001
The Pharmaceutical Research and Manufacturers Association (PhRMA) launched an initiative to eliminate the paper package insert, proposing that it be replaced by electronic availability.
FDA-funded study at the University of Wisconsin School of Pharmacy: The “Svarstad Study” tests the progress of Consumer Medication Information made against the goals set by 1995’s Public Law 104-180.
2003
FDA holds public hearing as required by PL 104-80 on the results of the Svarstad Study.
2005
FDA requires that Medication Guides be developed for all anti-depressants and NSAIDs.
2006
FDA issues final regulations on Package Inserts (PIs); requires Highlights section, minimum font sizes, clearly defines content and format. Printed pharmaceutical packaging suppliers invest to enable full compliance in a timely manner.
2008
National Association of Boards of Pharmacy repeats the 2001 study on Consumer Medication Information (CMI) by the University of Wisconsin School of Pharmacy; this study conducted through the University of Florida College of Pharmacy.
2009
FDA announces in the Federal Unified Agenda its intention to require electronic Package Inserts (PIs) to completely replace printed paper labeling.
2013
House of Representatives passes H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013: This bill includes a section that would allow manufacturers to replace FDA-approved, manufacturer supplied printed Package Inserts (PIs) with “electronic means.”
General Accountability Office (GAO) publishes, “Electronic Drug Labeling“: This concluded that relying on electronic labeling as a complete substitute for printed paper labeling “could adversely impact public health.”
Congress passes H.R. 3204, Drug Quality and Security Act: This act removed the language in the House bill that would have replaced printed Package Inserts (PIs) with electronic means.
FDA continues publication in the Unified Agenda of its intention to allow electronic package inserts instead of paper.
2019
H.R.5198 – Patients’ Right to Know Their Medication Act of 2019 was introduced in the House of Representatives by Representatives Jared Golden (D-ME) and Buddy Carter (R-GA). This legislation institutes a standardized printed PMI dispensed with all prescription drugs in an outpatient setting.