SNOMED Update - May 2007

In April 2006, the U.S. Food and Drug Administration (FDA) announced the adoption of the "Problem List" subset of the Systematized Nomenclature of Medicine (SNOMED) to electronically code important terms in the Highlights section of the electronic structured product labeling (SPL) for prescription drugs. (Click here to view the full press release of that announcement.)

Beginning June 30, 2006, companies were expected to code clinical trials and safety data to MedDRA and then additionally code the text in the Highlights section of the product label to the Problem List subset of SNOMED at the time of SPL submission.

However, subsequent to that original announcement, the FDA has released (in March 2007) a draft guidance document that explains that the FDA's Center for Drug Evaluation and Research (CDER), rather than individual applicants, will index SPL in product labeling for human drugs. Having FDA code the SPL will result in better consistency and eliminate possible intercoder variability that could occur if individual sponsors were responsible for the SPL coding.

What This Means

There is a 60-day comment period for this draft guidance.  Comments should be submitted to the FDA Division of Dockets Management. Detailed instructions for submitting comments are available at the beginning of the draft guidance document.

In the meantime, the FDA will not require individual applicants to code the text in the Highlights section of their SPL submissions. As a result, you will not need to implement SNOMED within your SPL submissions.

Your clinical trials and safety data should continue to be coded to MedDRA as before. In other words, the original FDA announcement and the subsequent draft guidance document should have no impact on how your data is currently coded.

The FDA remains committed to MedDRA for adverse event reporting, as evidenced by its plans for AERS II, the FDA's new adverse event reporting system.

Contact Us If You Need More Information

Our dictionary experts are available to assist you with any questions or concerns about the FDA announcements regarding the use of SNOMED.

Please feel free to contact us for further information or assistance.