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T-34: Otsuka’s Experience on eSubmission of Promotional Labeling and Advertising Materials via the eCTD FDA Gateway

Poster Presenter

Joanne Hathaway

Senior Manager, Promotion Compliance
Otsuka Pharmaceutical Commercialization & Development
United States

Objectives

Successfully submit all promotional labeling and advertising sequences, and related materials, via FDA electronic submission gateway (ESG) in eCTD format to fulfil regulatory requirements before finalization of the FDA Guidance on electronic submissions to achieve operational efficiencies.

Method

Leveraged our existing expertise and FDA guidance, to prepare a series of test submissions. Worked with OPDP, FDA eSubmission team, and Otsuka colleagues to confirm or resolve issues to ensure successful submissions. Finally, align and train commercial colleagues to ensure a seamless transition.

Results

In 2017, Otsuka’s Promotion Compliance (PC) and Regulatory Submissions teams collaborated and coordinated efforts with Office of Prescription Drug Promotion (OPDP) to ensure submissions of promotional labeling and advertising (PL&A) in eCTD format were guidance compliant and accepted through the eCTD test gateway. The following submission scenarios were tested: Form FDA 2253, advisory comments (launch and non-launch), enforcement actions, multiproduct submissions (grouped and ungrouped), and information request responses. During testing, several challenges were observed including: broken hyperlinks, playing embedded videos in pdf files, and validation issues. Special considerations for PL&A material submissions are laid out in the FDA guidance on electronic submissions. Upon achieving a 100% success rate for all submission types, PC approached marketing teams, identified one to train, and piloted the new process. After a successful pilot program, efforts began to expand eCTD submissions across all existing and new brands. In 2018, all regulated PL&A submissions for Otsuka drug products were converted to the eCTD submission process. This resulted in improved efficiencies including: elimination of postal transit times, mailing costs and preparation, faster error corrections, and electronic acknowledgement of submission receipt from the FDA gateway, and leveraged our automated workflows and reduced overall timelines for additional operational efficiencies. As a result, this generated an estimated 60% reduction on shipping costs in 2018. It is anticipated that this savings will rise in 2019 now that all brands have been converted to eCTD. All Electronic Regulatory Submissions including PL&A submissions are now housed in a single Enterprise Document Management System and relationships of materials are accessible in the eCTD viewer making administration and auditing more efficient.

Conclusion

Implementing a well, laid-out plan when approaching electronic PL&A submissions through the FDA gateway was instrumental in achieving positive results. A stepwise approach was used and consisted of 1) obtaining internal alignment between involved functional areas of PC and Regulatory Submissions teams. 2) Once a plan was in place, testing of the various submission types was accomplished with assistance from OPDP to make sure every submission type was accepted through the FDA test gateway and the corresponding submission documents were placed under the correct eCTD section header per The Comprehensive Table of Contents Headings and Hierarchy. Test submissions were a critical step as it helped identify issues early and enabled us to find adequate solutions. It was important to test every submission type and every possible iteration. As issues arose, problems were easily addressed and solved such as work arounds for broken hyperlinks and video embedding issues. This helped build confidence and achieve a level of comfort in preparing for our first PL&A eSubmission. 3) Having all the pieces in place, the final step was to pilot a single product after updating the application(s) to the required eCTD specification. Having a clear explanation and setting of expectations to marketing teams and their vendors helped solidify a path to success before rolling out the process to all marketed applications across the company. Starting the conversion on electronic submissions early allowed us to be thoughtful in our approach, so not to rush or feel pressured. At this time, the current FDA guidance has not been finalized and paper submissions are still being accepted. The steps taken, and the successful outcomes achieved, demonstrate that there is no reason to wait until the draft guidance becomes finalized. In conclusion, convert to eCTD submissions now, improve efficiencies and reduce costs for submitting PL&A materials via FDA gateway.