FDA Seeks Electronic Drug Labeling for Providers

The Food and Drug Administration wants to make obsolete paper-based distribution of prescribing information to prescribers of drug and biological products.

In a recently proposed rule, FDA wants to change its labeling requirements “to require that the prescribing information intended for healthcare professionals be distributed electronically and, with few exceptions, not in paper form.”

The FDA’s goal is to make sure that labeling information is as updated as possible, as by their nature paper forms may not contain the most current information. “FDA is taking this action to ensure that the most current prescribing information for prescription drugs will be available and readily accessible to healthcare professionals at the time of clinical decision making and dispensing,” according to the proposed rule.

Exceptions to electronic distribution of  information under the proposed rule would include patient labeling including package inserts and medication guides, prescribing information accompanying promotional labeling, and in certain cases were electronic distribution may be unsafe, technically infeasible or 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.”

Under the proposed rule, manufacturers would submit prescribing information for posting on FDA’s labeling repository website each time a change is made in a label. The product container label and packaging would have statements directing prescribers to the website.

FDA estimates manufacturers will save $52-$164 million annually, and pharmacies will incur annualized costs of $47-$89 million. The 22-page rule is available here.