History

The History of Medication Information on Paper

YEAR	LEGISLATION AND FDA ACTION
1938	The Food, Drug and Cosmetic Act. (Wikipedia reference) 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	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.”
2013	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.”
2013	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.
2013	FDA continues publication in the Unified Agenda of its intention to allow electronic package inserts instead of paper.