IMPLEMENTATION ISSUES Industry Perspective

Content Coding Standards Will there be a depth-of-coding guideline? Or any other mechanism to ensure consistency in the depth of coding across products/companies. How would consistency be achieved if more than the items reflected under Highlights could be coded? Coding Instituting a nomenclature for coding may not be enough. May need additional rules. How will SNOMED and MedDRA play together in/behind US labeling? Should human readable words be SNOMED PTs or MedDRA PTs? Lack of codability/structurability The likelyhood that advice reaches HCPs should not depend on its codability. Where an item cannot be coded, text should be displayed. Crisp sentence may be better than full paragraph. Content of human-readable labeling compared to computer-readable labeling CRL should not contain more (more specific) information than HRL

Content Coding (continued) “Shades of grey” and nuances (must, should, consider, particularly) How can they be retained (SNOMED?) If they cannot be retained, are there compensatory solutions? Lists of examples How can they be handled? Coding compliance What if SPLs were left uncoded or partially coded? Regulatory and legal implications. Voluntary conversion of old labels Is non-conversion an option if “direct-from-label” decision support systems are widely used? Third party information for decision support systems Do they have special requirements?

Content Coding (continued) “Information brokers” How will they benefit from SPL? Text to code: Quality Can we get tools to make this process easier and more transparent? Can we get a “code viewer” that allows us to verify that our coding is consistent with full text?

General SPL Implementation Generic labeling Need realistic roll-out timelines that respect software development timelines. When will coding for highlights be required? How will FDA interact w/ industry – e.g. coding and changes to IG Lifecycle issues need to be addressed so that they can be considered in the development of systems/processes Have ballot coming – how to make decisions on comments….how to manage within RCRIM Generic labeling How will comparison document be affected? Will proposed generic labeling be refused because not coded? Could generic labeling just link to clinical content of branded label? What if generic label changes before branded label?

Process How can parallel changes be handled (e.g. CBE plus several pending PAs)? How will CBEs be handled? Definition of which label content to submit w/ annual report? Will we still have to submit history of changes and current and last approved once ELIPs has all labeling in SPL (after first year) Will industry be able to review FDA approved SPL before it is posted to NLM?(even for so-called “minor” changes?)

Physicians Labeling Rule Implementation issues – printing and paper size FDA reviewer consistency What is the most important information What gets truncated due to space

Implementation: Coding What codes will be required? What code systems will be followed? What markup is optional? What is required? Which sections/excerpts/structured content must I code? If I don’t put in an “optional” code, could that result in a refusal to file? What if “more exact encoding of concepts” begins to offer competitive advantages?

Implementation: Validation What constitutes a “valid” SPL? Valid according to schema? Entire narrative is present? All required elements, but not all optional elements, are present? Some or all codes are present and point to agency-approved code systems? Codes are congruent with narrative? Some/all/none of the above? What will the agency validate (in new and updated submissions), and how?

Implementation: Guides & Info When will the current IG be synchronized with the current (v2a) schema? (Needs to be before October!) Can we create some “helper” info? List of frequently asked questions (FAQs) “Narrative” history to facilitate baselining newcomers to the Working Group Can we centralize SPL information?

Implementation: Submission Given the hierarchical structure of SPL content, how will partial submissions (i.e., only changed components) be managed? How will changes in structured content be managed? What does a flow diagram for all submissions look like? (Start with how is an SPL submitted with an eCTD and then define the flow for every other type of submission!)

Implementation: Submission How will an SPL be delivered to the agency? What information will be packaged with it (i.e., NDA number), and how? How will an SPL be returned to the sponsor (with comments or changes)?