According to a notice in the Federal Register, prescribing information, which is updated periodically, is currently distributed via paper or within the package from which a prescription drug is dispensed. However, the agency decided that because the paper form of the prescribing information can become outdated quickly, electronic distribution is necessary so the info can be updated in real-time.
“FDA is taking this action to 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 decisionmaking and dispensing,” the agency says.
New Requirements
Under the proposed rule, manufacturers would be required to submit the prescribing information to FDA, which would then post it on the Web site www.labels.fda.gov each and every time there is a change in the labeling. Manufacturers would also be required to review the labeling posted at FDA’s Web site to verify that the correct version of the labeling appears in the repository, and to promptly notify FDA if the correct version is not posted.
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.
Manufacturers would also be required to set up a tollfree 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 so prescribing information is accessible when Internet access is not available.
FDA notes that it may grant an exemption from the electronic distribution of labeling requirements when compliance could adversely affect the safety, effectiveness, purity, or potency of the drug, is not technologically feasible, or is otherwise inappropriate.
Examples of circumstances where it may be appropriate to exempt a product include a product intended for use in an emergency room or a product that may be stockpiled for an emergency.
The FDA estimates that the industry will save a net of between $5m and $73.5m because of the proposed rule. Manufacturers can provide comments on the proposal over the next 90 days.