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Regulatory Focus™ > News Articles > What's Holding up FDA's Electronic Drug Labeling Rule?

What's Holding up FDA's Electronic Drug Labeling Rule?

Posted 10 February 2014 | By Alexander Gaffney, RAC

Legislators with the two committees that oversee the US Food and Drug Administration (FDA) want to know: What's holding up the agency's electronic labeling rule for pharmaceuticals?


Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce uniformity were first passed. Those measures were substantially updated in 2006 under FDA's Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, better known as the Physician Labeling Rule (PLR).

But other forms of labeling are also regulated by FDA, including Medication Guides and package inserts.

At present, all 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.

But in recent years, some industry stakeholders - most notably pharmaceutical manufacturers - have proposed moving from a paper-based labeling system to an electronic one in which the majority of the drug's labeling information would be contained online.

Proponents of that system have argued 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.

A Government Report

GAO's report noted a mix of potential benefits and harms.

On the benefits side of the equation, electronic labeling was seen as allowing labels to immediately reflect the most up-to-date safety risks.

In addition, FDA-approved labeling typically serves two audiences simultaneously: patients and healthcare providers. Switching to an electronic-based system could allow both groups to view tailored 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.

On the harms side of the equation, GAO's report said the change could be more inconvenient for some patients and providers, and in particular for older patients who might not know how to access the information or lack Internet access altogether. The user-friendliness of existing drug information platforms was also called out, with GAO noting that some doctors may instead rely on easy-to-use but inaccurate sources of information.

Proposed Rule: Details

Based on GAO's report, FDA has been working on a replacement regulation, entitled Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products.

The rule, as described in the Office of Management and Budget's (OMB) Unified Agenda, "would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used."

"This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products," FDA wrote.

The rule, which has been deemed "economically significant" based on its anticipated costs, requires review and approval by OMB before FDA can release it to the public. The problem is that the rule has been under development and review since at least 2009, based on OMB records.

Legislators: Where is this Rule?

And after five years, some legislators are getting impatient.

On 7 February 2014, a bipartisan and bicameral group of legislators wrote to OMB Director Sylvia Burwell with a question: Where is this rule?

"[FDA] has repeatedly included electronic labeling in its semi-annual regulatory agenda," the group wrote in its letter. "However, FDA's specific plans regarding electronic labeling have yet to be made public."

"Release of the proposed rule will allow for a thoughtful examination of this issue and provide stakeholders an opportunity to comment and provide input on FDA"s proposed implementation of electronic labeling," they continued. "We therefore encourage you to prioritize release of this proposed rule, and we appreciate your work on this important topic."

The letter was signed by the chairmen and ranking members of both the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions (HELP) Committee, indicating an uncommonly unified stance on the release of the rule.


Letter to OMB

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