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Regulatory News | 16 December 2014 | By Alexander Gaffney, RAC
In a long-anticipated and major move, the US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically.
The proposed rule, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products, comes after years of development at FDA.
Under Section 1140 of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), legislators called on the Government Accountability Office (GAO) to study the advantages and disadvantages of largely doing away with paper-based labeling for drug products, and instead moving to an electronic system.
GAO's subsequent report found both likely benefits and potential downsides to an electronic-based labeling system.
Electronic labeling, stakeholders told GAO, would ensure that all labeling reflected the most up-to-date safety risks. At present, paper-based drug labels 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, GAO was told.
But the proposal also had its downsides. Some stakeholders told GAO they were concerned the labeling measure wouldn't benefit elderly consumers, who might not know how to access the drug labeling online, or might not have Internet access. GAO also noted that counseling patients might become more difficult for doctors who would no longer have access to printed package inserts.
Read more about GAO's electronic drug labeling report here.
FDA's regulatory authority would also need to be updated, GAO noted. At present, it requires prescribing information to be located "on or within" the drug packaging. Other forms of prescribing safety information, such as medication guides (MedGuides) are allowed to be sent electronically, however.
FDA's proposed rule, published 16 December 2014, seems designed to avoid the vast majority of the potential downsides identified in GAO's report by instead focusing on "prescribing information intended for healthcare professionals."
FDA is proposing that such prescribing information with few exceptions, "will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed."
FDA said it hoped its proposal would "ensure that the most current prescribing information for prescription drugs will be available and readily accessible to health care professionals at the time of clinical decision-making and dispensing."
Notably, the electronic requirements do not apply to patient labeling, including package inserts and medication guides, or promotional labeling.
What the rule does require is 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."
In other words, FDA's proposal applies only to the drug's "professional labeling."
Under the new system, product manufacturers will be required to update the product labeling at FDA's labels.fda.gov website "every time there is a change in the labeling." They would also be required to verify that the correct labeling is posted on FDA's website, the agency said, and to "promptly notify" the agency if it is not.
Manufacturers would also be required to set up a 24-7 toll-free number where healthcare professionals could request paper copies of the prescribing information. This, FDA said, would ensure that persons without Internet access—such as in an emergency or power outage—could still access prescribing information.
Comments on the proposal are due to FDA within 90 days.
Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
Tags: Drug Labeling, Proposed Rule, Rule, Regulation, Proposed Regulation, Professional Labeling, Prescribing Information