Proposed rule from FDA requires electronic prescription drug labeling

December 23, 2014

According to a rule proposed by FDA in the Federal Register (December 18, 2014), healthcare providers would receive prescription drug and biologics product labeling information via an electronic system, thus replacing the use of paper to provide such information on the safety and effectiveness of human prescription drugs.

According to a rule proposed by FDA in the Federal Register (December 18, 2014), healthcare providers would receive prescription drug and biologics product labeling information via an electronic system, thus replacing the use of paper to provide such information on the safety and effectiveness of human prescription drugs.

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The rationale behind FDA’s decision is based on the fact that electronic information can be quickly updated as needed. Healthcare providers as a result will have access to the latest prescribing data regarding labeling changes, avoiding the dissemination of outdated paper-printed labeling information.

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The proposed rule would make the manufacturers of drugs provide FDA with immediate prescribing data when changes are made to labeling information, allowing FDA to quickly update its public labeling website. The drug manufacturers would also be required to review and verify the website’s information per their products as correct, and to notify FDA about site information that is incorrect right away.

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The proposed rule will not apply to printed drug information nor to consumer information on prescription instructions.

Under this proposed rule, language directing drug prescribers to view prescribing information on FDA’s labeling site would be required on all prescription drug containers and outside packaging. Further, the manufacturers would be required to provide a toll-free phone number, accessible 24/4, allowing for the receipt of requests for paper copies of prescribing information.

FDA would be able to exempt any agency from adhering to the proposed rule when so doing would result in adversely affecting such issues as safety, effectiveness, potency, or purity of a given drug. This exemption would also cover the times when it is either inappropriate or not possible technologically to comply with this rule.

The proposed rule from FDA, which the agency estimates will result in a savings to the drug industry of $52 million to $164 million, will be available for comment until March 18, 2015.