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From Health Law Daily, December 17, 2014

FDA moves to eliminate paper physician prescribing information from Rx drugs and biologics

By Harold M. Bishop, J.D.

Prescribing information for health care professionals in human prescription drug and biological products, and blood and blood components intended for transfusion, would be required to be distributed electronically, except for a few exceptions, under an FDA proposal.  The electronic distribution requirements would not apply to patient labeling (i.e., patient package inserts and Medication Guides), or to prescribing information that accompanies promotional labeling, which would continue to be provided in paper form.

Rationale. The FDA is concerned that prescribing information for health care professionals, which is currently provided in paper form with the dispensed product, may not contain the most current information because it may have been printed and distributed prior to more recent labeling changes. The FDA hopes that requiring the distribution of electronic prescribing information, which can be updated in real-time, will make the most recent prescribing information readily accessible to health care professionals at the time of clinical decision-making and dispensing.

This proposed rule also complements other FDA and HHS initiatives that are intended to provide accessible electronic drug product information to health care professionals, consumers, and the public. These initiatives include the electronic prescribing provisions, the requirement for bar codes on certain drug product labels, the requirement for submission of electronic labeling in product approval applications, and electronic registration of drug establishments and listing of drug products.

Manufacturer submission and review requirements. To implement the proposed rule, the labeling regulations would be amended to require manufacturers to submit the prescribing information to FDA for posting on FDA’s publicly available labeling repository ( each time they change their labeling. Manufacturers would also be required to review the labeling posted on the FDA’s online label repository to verify that the correct version of the labeling appears, and to promptly notify FDA if the correct version is not posted.

Container requirements. The proposed rule would require a product’s immediate container label and outside package to bear a statement directing health care professionals to the FDA’s online label repository ( to view the electronic version of prescribing information. The container statement would also provide a toll-free 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.

Toll-free number requirements. Each manufacturer would be required to ensure their toll-free number service is available 24 hours a day, 7 days a week under the proposed rule. The FDA believes that this will ensure that the prescribing information is accessible when Internet access is not available to the health care professional.

Exemptions. The proposed rule allows the FDA to grant an exemption from the electronic distribution requirements when compliance could adversely affect the safety, effectiveness, purity, or potency of the drug, is not technologically feasible, or is otherwise inappropriate. For instance, the FDA anticipates that if may be necessary to exempt products intended for use in an emergency room or products stockpiled for an emergency.

Under this exemption, manufacturers would distribute prescribing information in paper form on or within the package from which the product is dispensed.

Costs to industry. After initial set-up costs, the FDA predicts that industry will experience net savings by providing the prescription information electronically. The FDA recognizes that pharmacies will incur net costs due to initial capital costs to access the information, increased search time when accessing the information and the printing cost when a request is received for the prescribing information in printed form. The FDA, however, does not believe that there will be cost increases to most health care professionals to access the information.

The official version of the proposed rule will publish in the Federal Register on December 18, 2014. Comments will be due within 90 days of publication.

MainStory: TopStory DrugNews FDCActNews DrugBiologicNews GenericDrugNews LabelingNews PrescriptionDrugNews SafetyNews

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