LABELING CONTENT SUBMISSIONS TO BE PUT IN SPL FORMAT

Beginning at the end of the month, the FDA will require drugmakers to adopt the structured product language (SPL) format for certain human drug labeling submissions, according to an agency official.

On Oct. 31, the FDA will implement its new electronic labeling information processing system (ELIPS), which cannot read labeling submissions in the traditional PDF format, Randy Levin, director of health and regulatory data standards, told FDAnews. ELIPS will automatically retrieve electronic SPL labeling content for new drug applications abbreviated new drug applications and biological licensing applications from the agency's electronic document room and make them available to reviewers, he said.

The agency originally established a late-2004 deadline for drugmakers to convert submissions to SPL, but the target date was postponed several times to allow drugmakers to prepare for the switch and to allow various FDA technology initiatives to be completed.

Few drugmakers have submitted SPL documents, but, based on preliminary conversations with industry and test submissions, the agency does not expect significant problems, Levin said. The FDA, drugmakers and technology experts worked with Health Level 7 (HL7), a standards organization, to develop the SPL schema. Pharmaceutical companies that participated in the HL7 SPL working group are "way ahead of the game," and others "missed a chance to get involved," Levin said.

The FDA recently posted an "SPL Implementation Guide for FDA Content of Labeling Submissions" to help industry prepare for the change, Levin said. The guide can be found at http://www.fda.gov/cder/regulatory/ersr/SPL2aIG_v20051006_r1.pdf (http://www.fda.gov/cder/regulatory/ersr/SPL2aIG_v20051006_r1.pdf).

Other SPL resources are online at http://www.fda.gov/oc/datacouncil/spl.html (http://www.fda.gov/oc/datacouncil/spl.html), including a final guidance document and the SPL implementation schema.