The agency is proposing to require pharmaceutical firms to provide healthcare providers with real-time electronic updates of drug label changes, forgoing printed labels, a change the agency says is intended to ensure that healthcare professionals and patients have the most current version of prescribing information.
The proposed rule, “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products,” comes after years of development at the regulator.
Lawmakers called on the Government Accountability Office to study the advantages and disadvantages of largely discarding paper-based labeling for drug products to move to an electronic system. The GAO’s report contained both likely benefits and potential disadvantages of an electronic-based labeling system. Stakeholders told the GAO that electronic labeling would ensure that all labeling had the safety risks, while currently, paper-based drug labels don’t always reflect a new safety risk until new stock is produced, requiring prescribing entities to recall specific safety alerts.
Additionally, contrary to many types of communications that have a single intended audience, FDA-approved labeling normally serves two audiences at the same time: patients and healthcare providers. Transitioning to an electronic-based system could enable both groups to view information in a more user-friendly format, the GAO was told.
The GAO was also told, however, that there was concern that electronic labeling wouldn’t benefit the elderly, who may not know how to access the drug labeling online, or may not even be able to access the Internet. The GAO also said that counseling patients could become more challenging for doctors who would stop having access to printed package inserts.
The FDA’s proposed rule appears to be designed to dodge most of the potential disadvantages noted in the GAO report, instead placing focus on “prescribing information intended for healthcare professionals.” The electronic requirements don’t pertain to patient labeling, only to a product’s “professional labeling.”
In a Federal Register notice, the agency proposed requiring manufacturers to submit prescribing information intended for healthcare professionals to the FDA, which would subsequently post it on its labels.fda.gov website every time there is a modification in the labeling.
The rule requires that container labels and outside packaging of products include a link that brings the prescribing physician to the publicly accessible online repository containing the label’s most up-to-date instructions, forcing pharmaceutical companies to keep vigilantly monitoring their repository listing and notify the FDA of any changes in labeling that have yet to be displayed on the site.
Container labels must also include a toll-free number for physicians who lack Internet access, although inserts and medical guidelines meant for patients and often slipped into packaging, as well as labeling appearing on promotional materials, are exempt from the regulation. The FDA said products meant for use in emergency rooms or that may be stockpiled for an emergency are examples of cases where it could be appropriate to exempt a product.
The agency anticipates the rule will save the industry between $5 million and $74 million over a 10-year period, primarily in printing costs, with pharmacies expected to incur costs of between $47 million and $89 million over 10 years in access costs, increased search time and the printing of labels when requested.