FDA Issues Structured Product Labeling Guidance; Says Delays Will Not Occur

Rockville, MD, (June 5, 2009)-The US Food and Drug Administration issued a new guidance this week on indexing structured product labeling (SPL). The Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) will begin indexing SPL in the product labeling for human drug and biologic products.

SPL became a requirement in October 2005 when FDA stated that SPL in extensible markup language (XML) was the only electronic format for content of labeling that CDER could process, review, and archive, according to the guidance. The agency is now recommending that content be submitted in SPL.

SPL enables the electronic exchange of the content of labeling and other regulated product information. It also enables the inclusion of indexing elements with product labeling. Indexing is made possible by machine-readable tags that are inserted into the label, but that do not appear on the actual printed label (consumers cannot see them). With these tags, individuals using clinical-decision support tools and electronic prescribing systems can more easily and rapidly search and sort product information in product labeling.

“Being able to electronically access labeling information and to search and sort that information is an important step toward the creation of a fully automated health information exchange system,” states the guidance.

The change also will help to decrease prescribing errors and enhance the safe use of medical products. For example, says the guidance, a full-text search of the content of labeling for hepatoxicity will miss labelings that use the term liver toxicity. New indexing elements based on standards adopted for use in the healthcare setting will address this problem.

The new guidance comes upon the completion of a six-month FDA pilot project that evaluted how best to add indexing elements to products. It also comes approximately two months after FDA issued a draft guidance on structured product labeling. The new guidance addresses some of the suggestions received from industry based on the draft, including more concrete advice on how applicants can recommend indexing terms to the agency and how indexed terms will be identified and shared.

Applicants are advised to suggest indexing terms with the SPL file in their regulatory submission. Because the SPL indexing process is independent from the labeling review process, FDA states that SPL indexing will not affect review times or delay approvals. Moreover, the applicant’s SPL file will remain unchanged by the indexing process. However, says the guidance, indexing considerations may be incorporated in the standard labeling review discussions.

The guidance notes that the labeling process will apply to all products, not just those subject to 21 CFR 201.57. FDA will index SPL using a phased approach, starting with pharmacological class, and is seeking public input about future phases.

The final guidance can be accessed here. Comments on the guidance can be submitted electronically here.