ESubmission of Promotional Labeling and Advertising Materials via the eCTD FDA Gateway : The Time Has Come for Advertising and Promotion to Submit in Module One.

Abstract

In June 2019, the Food and Drug Administration (FDA) issued its final Guidance on submission of advertising and promotional materials to the Office of Prescription Drug Promotion (OPDP) in eCTD format through the electronic gateway. Our goal was to put in place a stepwise plan and clear process to submit these materials in advance of June 2021 when electronic submissions become mandatory. The first step was to test every submission type and every possible iteration, therefore, as issues arose, problems could be easily addressed and resolved. This helped build confidence and achieve a level of comfort in preparing for the first eSubmission. To accomplish this, testing was performed through the gateway including: Form FDA 2253 (and accompanying promotional materials), advisory comments (launch and non-launch), enforcement actions, multiproduct submissions (grouped and ungrouped), and information request responses. The second step was to obtain internal alignment between involved functional areas to pilot a single brand. Finally, after a successful pilot program, eCTD submissions were expanded across all other brands. This paper discusses the stepwise approach taken, considerations for electronic submissions and results for improved efficiencies and cost savings. Implementing a well, laid-out plan, and starting the conversion early, allowed us to be thoughtful in our approach. The steps taken, and the successful outcomes achieved, demonstrate that there is no reason to wait for submitting promotional materials via the FDA gateway.