On December 18, the FDA announced a long-anticipated proposed amendment to the prescription drug and biological product labeling regulations requiring electronic distribution of prescribing information intended for healthcare professionals. 79 Fed. Reg. 75506 (Dec. 18, 2014). Currently, this prescribing information – often called the Package Insert or PI – is distributed in paper form either within the product packaging or on the product itself. Under the proposed rule, prescribing information intended for healthcare professionals will not be distributed in paper form, except as provided by the new regulation.

Background

In the 2012 Food and Drug Administration Safety and Innovation Act, the US Congress called on the Government Accountability Office (GAO) to study the benefits and disadvantages of eliminating paper-based labeling for drug and biological products, and moving to an electronic system.

The GAO’s July 2013 report (GAO-13-592) found both likely benefits and possible downsides to an electronic-based labeling system. For example, stakeholders noted that electronic labeling would ensure that labeling is up-to-date and reflects the most recent information on safety and usage. Under the current paper-based system, healthcare providers learn of new safety or usage information in safety alerts or when the next batch of paper PI’s are printed and distributed.

Stakeholders also pointed out that because the information in a PI is intended for both doctors as well as patients, an electronic PI could be made more user-friendly. On the other hand, some stakeholders warned the GAO that the proposal might disadvantage some patients, particularly the elderly, who may lack web access or know-how.

Major provisions

In order to address these concerns, the proposed rule provides that patient labeling (e.g. medication guides and patient-specific PI’s) will continue to accompany products in printed form. Similarly, under the rule, prescribing information accompanying promotional labeling, will continue to be provided in paper form.

Under the proposed rule, drug and biologic manufacturers must submit prescribing information to the FDA for the agency’s public labeling website whenever there is a change in the labeling. Manufacturers would also be responsible for reviewing the labeling posted on the FDA’s website in order to verify that the correct version appears on the website.

Additionally, the proposed rule would require that a product’s container label and outside package direct healthcare professionals to the FDA’s labeling website and to list a toll-free telephone number – maintained by the manufacturer – to address requests for paper copies of the prescribing information.

The proposed rule would allow the FDA to exempt a manufacturer from the electronic distribution requirements when compliance with the rule:

  • could adversely affect the safety, effectiveness, purity or potency of the product;
  • is not technologically feasible; or
  • is otherwise inappropriate.

Comments on the proposed rule are due in 90 days (March 18, 2015).

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