Last month, the Food and Drug Administration (FDA) published a proposed rule, 79 Fed. Reg. 75506, requiring manufacturers to distribute prescribing information (PI) electronically—in lieu of paper copies—to satisfy the regulatory requirement that a prescription drug bear adequate instructions for use on or within the drug’s package. Traditionally, manufacturers have met this requirement by providing a copy of the PI printed on thin paper in small font, and folded in an origami-like fashion so that the PI can fit in the drug carton or be attached to the drug’s packaging.
The proposed rule would require manufacturers to:
- Submit electronic copies of PIs to be uploaded to FDA’s labeling repository (www.labels.fda.gov), including updated PIs within 2 business days after approval of a labeling change by prior approval supplement and on the same day that a changes being effected supplement is submitted to the agency;
- Verify that the versions of the PIs posted on FDA’s labeling repository are correct and current, and notify FDA promptly if a PI posted in the labeling repository is not a correct or current version;
- Maintain a toll-free number on a 24/7 basis that health care practitioners (HCPs) can call to request that a copy of a PI be emailed, faxed, or mailed; and
- Affix a statement on the immediate container label and outside package of a prescription drug product that directs HCPs to the labeling repository and provides the toll-free number.
FDA’s proposed requirements would apply only to PIs provided on or within prescription drug packages or containers. FDA specifically does not intend for this electronic distribution requirement to apply to PIs that accompany promotional labeling or to patient labeling, and states that these types of labeling should continue to be provided in paper form. Indeed, the agency noted that it is examining ways to improve the content and distribution of patient labeling, so proposed changes to patient labeling may be forthcoming in a separate initiative.
FDA emphasizes that the purpose of this proposed rule is to assure that the most current versions of PIs will be available and accessible to HCPs. The agency cited research that found that 3-39 months can elapse before a safety labeling change is reflected in paper copies of PIs that are distributed with drug packages and containers. FDA also anticipates that the information in PIs would be more user-friendly and accessible to HCPs and patients (e.g., searchable, able to be viewed in a larger font size). Nonetheless, the proposed rule acknowledges that there may be certain limited circumstances in which the lack of a paper copy of the PI with the package or container may have an adverse effect on the safety or effectiveness of the product (e.g., a product intended for use in emergency situations). In such cases, a manufacturer could seek, and FDA could grant, an exception to the electronic distribution requirement.
Recognizing that a 2013 GAO report found “no consensus” on whether the potential advantages of an exclusively electronic PI system would outweigh its potential disadvantages, and in light of concerns expressed during a 2007 FDA public meeting on this topic, FDA is soliciting comment on several aspects of this proposed rule. Comments are due by March 18, 2015 to Docket No. FDA-2007-N-0363.