Efforts continue to eliminate paper Package Inserts, currently marked by the Food and Drug Administration’s (FDA) publication in the Federal Unified Agenda in fall 2013 of its intention to pass a regulation requiring electronic inserts in lieu of paper. The FDA has not been forthcoming with the PPLA on its reasons and rationale for this potential regulation. This intention has been published by the FDA since 2009.
Here are other key dates in the fight.
The Pharmaceutical Research and Manufacturers Association (PhRMA) launched an initiative to eliminate the paper package insert, proposing that it be replaced by electronic availability.
The FDA issued a new regulation, almost six years in the making, specifying the content and format for Package Inserts. This regulation clearly called for paper inserts to continue, with an extended timeline for conversion of all PIs to its new format requirements.
The FDA held a public hearing on making Package Inserts available electronically. For the first time, pharmacies raised publicly the issue of cost if printing moved from the manufacturer responsibility to the pharmacy responsibility. Pharmacies also questioned the practicality, noting the limits of their printing capabilities and decreasing consulting time with patients.
In the Spring 2009 Unified Agenda, the FDA published its consideration of a rule that “would require electronic package inserts for human drug and biological prescription product, in lieu of paper, which is currently used.” PPLA efforts to talk with the agency contact at the FDA listed in the Unified Agenda were unsuccessful.
Publication of this intended rule continued in the Unified Agenda.
The House of Representatives passed H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013. Section 8 of this bill would have allowed manufacturers to replace FDA-approved, manufacturer-supplied Package Inserts with “electronic means.”
The General Accountability Office published a report entitled, “Electronic Drug Labeling” that studied the advantages, disadvantages, and barriers to relying on electronic labeling as a complete substitute for paper labeling. The GAO concluded that “relying on electronic labeling as a complete substitute for paper labeling could adversely impact public health.”
When H.R. 1919 was combined in conference with the Senate’s Drug Supply Chain Security Act, the language in Section 8 was removed. The House and Senate passed H.R. 3204, the Drug Quality and Security Act, which emerged from conference.
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.
With the support of dozens of Members of Congress, PPLA has secured policy rider language in each of the FDA’s annual funding bills, preventing the agency from spending resources on a move to electronic-only Package Inserts.