History
The History of Medication Information on Paper
YEAR |
LEGISLATION AND FDA ACTION |
1938 |
The Food, Drug and Cosmetic Act. (Wikipedia reference) |
1995 |
Public Law 104-80. |
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
|
2013 |
General Accountability Office (GAO) publishes,
“Electronic Drug Labeling.”
|
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. |