FDA Issues Proposed Rule to Require Electronic Drug Prescribing Information

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By Bronwyn Mixter

Dec. 16 — The Food and Drug Administration is issuing a proposed ruleon drug and biological product labeling to require electronic distribution of the prescribing information intended for health-care professionals, according to a notice to be published Dec. 18 in the Federal Register.

The FDA also said it is proposing that this prescribing information can no longer be distributed in paper form, except as provided by the regulation. The White House Office of Management and Budget has been reviewing the proposed rule since August 2013.

Prescribing information provides health-care professionals the information necessary for the safe and effective use of the product, the notice said. It is updated periodically to include the most current information, such as newly acquired safety information. Currently, the prescribing information is distributed in paper form, the agency said.

The paper form of the prescribing information may not contain the most current information because it may have been printed and distributed prior to more recent labeling changes, while the electronic form of prescribing information can be updated in “real-time,” the FDA said.

Electronic information can be updated more frequently, the agency notes.

“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 agency said.

The electronic distribution requirements of this proposed rule wouldn't apply to patient labeling (including patient package inserts and medication guides), or to prescribing information accompanying promotional labeling, which would continue to be provided in paper form, the agency said.

Major Provisions 

Under the proposed rule, drug manufacturers would be required to submit the prescribing information to the FDA for posting on the agency's publicly available labeling repository website every time there is a change in labeling, the notice said. Manufacturers also would be required to review the labeling posted on the FDA's website to verify that the correct version of the labeling appears in the repository, and to promptly notify the FDA if the correct version isn't posted.

Additionally, 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 labeling repository to view the electronic version of the prescribing information, the agency said. The statement also would provide a toll-free telephone number, maintained by the manufacturer, to receive requests for the manufacturer to send a paper copy of the prescribing information. The manufacturers would be required to ensure the toll-free number service was available 24 hours a day, seven days a week.

The proposed rule also would provide that the FDA 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, isn't technologically feasible or is otherwise inappropriate, the notice said. Manufacturers of exempt products would distribute prescribing information in paper form. 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 agency said.

Comments on the proposed rule, identified by Docket No. FDA-2007-N-0363, are due March 18.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

The Federal Register notice is at http://op.bna.com/hl.nsf/r?Open=bdmr-9rupau.