In an effort to help ensure that health care professionals (HCPs) have more timely access to labeling changes, on December 18, 2014, the U.S. Food and Drug Administration (FDA) unveiled proposed amendments to its drug and biological products labeling regulations, requiring manufacturers to distribute prescribing information to HCPs electronically (This proposed rule would apply to manufacturers, applicants, and persons who market prescription drugs (collectively, "manufacturers")). Under the current framework, manufacturers are required to provide prescribing information in paper form, and, as a result, prescribing information may contain outdated information by the time it is printed and reaches an HCP. The stated goal of the proposed rule, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products, is to protect both patients and their physicians by providing them with the most up-to-date safety information available (Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products: Proposed Rule, 79 Fed. Reg. 75506 (December 18, 2014), available here). In furtherance of this goal, the rule would require manufacturers to provide regular updates to the FDA's publicly-available online drug labeling repository, and to inform FDA of any changes in labeling that have not yet shown up online. As proposed, prescribing information intended for HCPs would no longer be permitted to be distributed in paper form with drug packaging, except in limited circumstances.
If promulgated, the rule would also require manufacturers to provide a link to the FDA's labeling repository website on the immediate container label and outside packaging of products, so that HCPs and the public can easily access the most up to date version of the prescribing information. The rule also requires the outer and inner containers to include a toll-free number for requesting a print copy, should a consumer or provider not have access to the internet. Exempt from the regulation are package inserts and medication guides intended for patients typically included in the product's packaging, as well as package inserts that accompany promotional materials (FDA explains that it excluded patient labeling from this proposed rule because it is examining methods to improve the content and distribution of patient labeling in a different initiative). Manufacturers would continue to be required to provide such materials in paper form.
Based on FDA's estimate, pharmacies would be hit hardest by the proposed regulation, which could cost them between $47 million and $89 million over 10 years in internet access costs, as well as the cost of printing labels when requested. However, FDA anticipates that this rule will save the pharmaceutical industry between $5 million and $74 million over 10 years, mostly in printing costs ( Id. (see Costs & Benefits section)). In addition to potential cost savings, FDA points to other potential benefits including aiding manufacturers in fulfilling their duty to warn, easing communication between manufacturers and health-care providers, and ensuring that all labeling reflects the most current safety risks.
The proposed amendments are not set to go into effect until six months after issuance of a final rule. This comes on the heels of another major step taken by the FDA towards electronic labeling. In June 2014, the FDA finalized a rule requiring drug manufacturers to report certain incidents of patient harm electronically, thereby avoiding delays in identifying new risks ( Available here). That rule takes effect in June 2015.