Regulatory Focus™ > News Articles > Industry Comments Indicate Displeasure with Medication Guides, FDA Looking at Single-Page Versions

Industry Comments Indicate Displeasure with Medication Guides, FDA Looking at Single-Page Versions

Posted 26 April 2012 | By

Comments on the US Food and Drug Administration's (FDA) Medication Guide requirements for prescription drug labeling indicate displeasure with the requirements, which are referred to as onerous, costly, excessive, poorly executed and otherwise burdensome.

The comments, contained in FDA's Federal Register posting, entitled Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements, reflects comments received after the agency's call for comments on the matter.

FDA said the comments fell into five main categories:

  • the length of Medication Guides continues to be "burdensome" which hinders its full potential
  • in some cases, it seems unnecessary that pharmacists should need to place a Medication Guide with every single prescription refill
  • the estimated burden of three minutes per Medication Guide for pharmacist compliance is "miscalculated"
  • there are costs to the distributor of Medication Guides that are not reflected in FDA's estimated burden
  • as Medication Guides have become available online, shifting the burden from manufacturers to pharmacies

FDA said in comments it is:

  • reevaluating whether one-page Medication Guides are feasible alternatives
  • standing by its guidance, Medication Guides-Distribution requirements and Inclusion in Risk Evaluation and Mitigation Strategies, in which it articulates its intended enforcement discretion for compliance with concern to the requirement to provide Medication Guides in certain settings
  • unsure as to if "miscalculated" refers to a burden calculated in excess or in deficit of the actual reporting burden, and is tentatively leaving its existing estimated burden calculation at three minutes per Medication Guide dispensed

FDA said it disagreed with the other two comments and would not be adjusting its guidance accordingly.


Read more:

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements


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