Regulatory Focus™ > News Articles > Government Report Finds Mixed Opinions on Proposed Drug Labeling Overhaul

Government Report Finds Mixed Opinions on Proposed Drug Labeling Overhaul

Posted 09 July 2013 | By Alexander Gaffney, RAC

A new report published by the Government Accountability Office (GAO), an intra-governmental watchdog agency, has found that the US Food and Drug Administration's (FDA) efforts to substitute three types of paper- based prescription drug labeling with an electronic-based labeling system is being met with strongly mixed reactions, indicating that the effort may not work as intended.


FDA currently regulates the content and layout of prescription drug labeling, including additional labeling that may be required of some drugs under a Risk Evaluation and Mitigation Strategies (REMS) plan.

Types of labeling include abbreviated package labeling, Medication Guides (typically assigned under a REMS), and package inserts, which include full prescribing information. At present, these labels are required to be provided in paper form, even as nearly all of them are also made available through electronic databases like FDA's Drugs@FDA database and the National Library of Medicine's DailyMed.

In recent years, some industry stakeholders - most notably pharmaceutical manufacturers - have proposed moving from a paper-based labeling system to an electronic one, arguing that it would be more efficient and effective at its purpose of informing healthcare professionals and patients. However, other groups, including drug labeling groups and patient advocates, have maintained that it would have the opposite effect and complicate an otherwise straightforward system.

Facing an impasse, the FDA Safety and Innovation Act (FDASIA) of 2012 called on GAO to issue a report identifying the advantages and disadvantages, which it released on 8 June 2013.

GAO's Report

GAO's report focuses on two aspects of drug labeling:

  1. the advantages and disadvantages of relying on electronic drug labeling as a complete substitute for paper labeling
  2. the barriers associated with relying on electronic drug labeling as a complete substitute for paper labeling

GAO's investigators then interviewed a wide range of stakeholders, including FDA, pharmaceutical manufacturers, patient groups and healthcare practitioners. What they found, however, was a distinct lack of consensus among those stakeholders.

"While stakeholders described a variety of advantages of electronic drug labeling that could improve public health, they also noted disadvantages that could offset advantages gained," GAO explained.

Electronic labeling, stakeholders said, would provide a number of benefits, including making sure that all labeling reflected the most up-to-date safety risks. At present, paper-based labeling may not reflect a new safety risk until new stock is generated, and prescribing entities must remember specific safety alerts (if they see them at all).

In addition, unlike many types of communications which have but a single intended audience, FDA-approved labeling typically serves two audiences simultaneously: patients and healthcare providers. Switching to an electronic-based system could allow both groups to view information in a more user-friendly format. For example, patients might see information presented in one way (such as with options to increase font size or hyperlinks to definitions of complex terms), while healthcare professionals might see a version with a search function to facilitate the discovery of potential safety risks.

Potential Disadvantages

But these potential benefits were in many respects balanced by the potential disadvantages. Stakeholders told GAO that forcing physicians to access drug labeling through electronic media could be inconvenient, confusing or unavailable, particularly for elderly patients who might be technologically illiterate or have no ready access to the Internet. In other cases, it might be faster to review paper labeling than to access a digital copy, other stakeholders argued.

The user-friendliness of the platform was also brought up as an issue, as neither Daily Med nor Drugs@FDA are particularly user-friendly platforms, and are instead intended for professionals with a deep understanding of medical terminology. Similarly, without a national standard for electronic drug information, some stakeholders said doctors might rely on less reputable sources for information, potentially subjecting them to labeling errors.

Finally, counseling patients was seen as another potential difficulty. Some doctors now will consult with patients by taking out a package insert and highlighting certain relevant parts-a practice that could not be done (or would require new functionalities) if the labeling was electronic.

FDA: Regulations Require Updating

FDA also raised a number of regulatory issues in its report, noting that to overhaul the labeling system to an electronic-based system would require "amending or reviewing certain federal regulations," as the proposed system "would not satisfy the current regulation."

"Specifically, FDA would need to amend the language that currently requires prescribing information to be 'on or within' the drug packaging," GAO wrote. Medication guides, however, are already permitted to be sent electronically, FDA added.

GAO's report was sent to Sens. Tom Harkin and Lamar Alexander of the Senate's Health, Education, Labor and Pensions (HELP) Committee and Reps. Fred Upton and Henry Waxman of the House Energy and Commerce Committee. The legislators will now need to determine what course of action, if any, is necessary.

GAO Report

Tags: Report, GAO

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