FDA’s long-awaited proposed rule requiring prescribing information distributed to health care professionals be in an electronic format aims to eliminate the use of paper. But the agency is requesting comments on whether a dual system providing both electronic and paper versions of prescribing information could provide the most current data.

The proposed rule, scheduled for publication in the Dec. 18 Federal Register, would not apply to patient labeling, including patient inserts and Medication Guides, or to prescribing information that accompanies promotional labeling, which will continue to be provided in paper form.

FDA proposes that labeling intended for health care professionals “will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed,” except as specified.

“We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs,” the proposed rule states.

Comments on the proposed regulation are due 30 days after publication in the Federal Register.

Under the proposed rule, manufacturers would be required to submit prescribing information to FDA every time there is a change in the labeling for posting on the agency’s labeling repository website (labels.fda.gov). Manufacturers would be required to review the labeling posted on this site and verify that it is the correct version.

A product’s immediate container label and outside package would also have to include a statement directing health care professionals to FDA’s labeling repository to view the electronic version of the prescribing information. The statement would also include a toll-free telephone number for health care professionals to call and request that a manufacturer email, fax, or mail the prescribing information.

Pharmacists Favor Retention Of Paper Labeling

Several stakeholders voiced support for the move to electronic format while others felt that paper information should remain available.

The National Community Pharmacists Association said electronic labeling is “a valuable and complementary component to paper labeling” but it should not be viewed as an effective substitute for paper labeling at this time.

The association said Internet access is not available to everyone and that shifting to electronic labeling would impose a cost burden on community pharmacies as they would have to print upon request prescription labeling that is now provided by drug manufacturers.

NCPA cited a 2013 General Accounting Office report that concluded there are advantages and disadvantages to an electronic-only system. It noted that a negative feature is the limitation on access to information Also see "Electronic Labeling Study By GAO Yields “No Consensus,” Avoids Cost Issue" - Pink Sheet, 9 July, 2013..

The American Pharmacists Association addressed the issue in 2007 comments to FDA. At that time it called for a flexible system in which paper package inserts would be available when electronic access is not feasible.

The Biotechnology Industry Organization said the release of the proposed rule is promising. In January it sent a letter to FDA Commissioner Margaret Hamburg and HHS Secretary Sylvia Burwell asking them to encourage the Office of Management and Budget to issue the regulation.

“In this modern era of ubiquitous information technology and real-time communication, this paper-based approach to the dissemination of important new medical information is wasteful, uneconomical, and inefficient,” BIO wrote. “As such, BIO fully supports replacing the paper USPI [US prescribing information] with electronic distribution, with paper copies available upon request.”

The Generic Pharmaceutical Association also sent a letter to Hamburg and Burwell in January in support of the proposed rule and encouraging FDA to finalize it as expeditiously as possible.

Is A Dual System Possible?

FDA said it considered a mandatory dual system for distribution of prescribing information in which both paper and electronic versions would be distributed simultaneously and the paper version could include a statement that it may not contain the most up-to-date information. But the agency said it is concerned that the potentially outdated paper version may be used and that health care providers may not ensure they are reading the current version.

The agency said it also considered a dual system that requires the electronic version of the prescribing information and permits a voluntary distribution of the paper version. However, the agency said this could cause confusion and workflow disruptions for health care professionals as it would be left to each manufacturer’s discretion to decide if the paper version would be distributed with its products.

FDA requested comment on a system that requires manufacturers to distribute the prescribing information electronically, and where paper prescribing is needed, dispensers, e.g., pharmacies, would have the option of ordering single or multiple copies of the paper prescribing information when ordering a shipment of the drug from the distributor.

FDA said it does not anticipate that dispensers would routinely order paper prescribing information since they would rely on the electronic version and because pharmacies usually have some other form of compendia purchased from a third party.

Despite its reservations, the agency requests comment on dual systems. “Specifically, we request comment on whether and how dual systems could achieve the goal of ensuring that health care providers have the most current prescribing information,” the proposed rule states.

“We also request comment on the structure of a dual system (e.g. if such a system should require both a paper and electronic version be distributed, or require the electronic version while allowing the paper version to be distributed voluntarily or ordered by dispensers), what kind of statement the paper prescribing information should contain to advise health care providers about the electronic version, and if there are concerns or benefits not identified by FDA with such an approach.”

Net Savings Estimated At $5 Mil. To $74 Mil.

FDA says that manufacturers may submit a written request to the agency for an exemption to the electronic distribution of prescribing information. The request must describe the reasons why this distribution could adversely affect the safety, effectiveness, purity, or potency of the drug; why it is not technologically feasible; or why it is otherwise inappropriate.

The agency noted that examples of circumstances where it might be appropriate to exempt a product from electronic labeling include a product that requires multiple steps for reconstitution, a product that is intended for use in an emergency room, or a product that may be stockpiled for using during an emergency. FDA also requests comments on the feasibility of applying electronic distribution of prescribing information to cell therapy products.

The proposed regulation follows similar rules moving drug information into an electronic format, including the requirement for submission of electronic labeling in product approval applications and electronic registration of drug establishments and listing of drug products.

FDA proposes that the regulation go into effect six months after publication of the final rule in the Federal Register with a compliance date of two years after the final rule is published. The agency said that six months is not likely to be sufficient time for many manufacturers to implement this rule and it thus proposes to exercise enforcement discretion for two years from the publication of the final rule.

As for the cost of the regulation, FDA says that at a 7% discount rate over a 10-year period, the annualized cost savings from the electronic format range from $52 million to $164 million and are predominantly savings to industry. The annualized costs range from $47 million to $89 million and are mainly incurred by pharmacies. And the annualized net savings range from $5 million to $74 million.

Electronic Prescribing Information: Proposed Rule May Not Completely Eliminate Paper

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