According to a proposal laid out in 22-page detail in the Federal Register on December 18, the U.S. Food and Drug Administration (FDA) is recommending

electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed.

The FDA is further proposing that

prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation.

Now … before pharmaceutical marketers and their advertising agencies get too excited,

The electronic distribution requirements of this proposed rule would not apply to patient labeling (including patient package inserts and Medication Guides), or to prescribing information accompanying promotional labeling, which would continue to be provided in paper form.

[Bold italic, underlined type added for emphasis.]

However, the FDA’s proposed regulation is clearly a first step toward the paperless distribution of prescribing information, given the increasingly widespread nature of electronic access to such data.

From a practical point of view, the current proposal would eliminate the need for provision of full prescribing information to hospitals, pharmacies, and physician’s offices along with standard packages of prescription drugs used to dispense product:

The proposed rule would require a product’s immediate container label and outside package to bear a statement directing health care professionals to FDA’s labeling repository to view the electronic version of prescribing information. The statement would also provide a toll-free telephone number, maintained by the manufacturer, to receive requests for the manufacturer to send an emailed, faxed or mailed paper copy of the prescribing information. The manufacturer would be required to ensure the toll-free number service was available 24 hours a day, 7 days a week.

The FDA is taking this action to ensure that health professionals always have access to the very latest update to product prescribing information. However, the agency is also estimating that this change might save manufacturers anywhere from $5 million to $182 million per year (which is a pretty wide range). However, it certainly ought to save manufacturers some money, and it also ought to save a lot of trees!

From the point of view of pharmaceutical marketers and their agencies, it has taken about 20 years since the development of the World Wide Web for the FDA to feel that they could take this initial step. Perhaps by December 18, 2034, the FDA may feel able to propose that physician-directed marketing communications carry links to full prescribing information and the same type of 24/7 toll-free telephone service too! Access to electonic-only prescribing information for patients and consumers might, of course, take a further 20 years!


About Mike Scott

Mike Scott is a highly experienced health care communications strategist with Calcium. He is also a board member of three different patient advocacy organizations. To get more detail, see his profile on LinkedIn.

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