This week the agency re-released its 2019 final guidance on regulatory submissions of promotional labeling and advertising materials in electronic and non-electronic format. According to AgencyIQ’s review, the documents contain few changes.
- Many types of regulatory applications are now required to be submitted electronically following the passage of Section 745(A) of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. The purpose of this change was to move away from paper-based applications and toward digital applications, which are easier for FDA to receive, review, store and analyze.
- The electronic common technical document ( eCTD) is the standard format for the submission of application documents and amendments to the FDA. The eCTD consists of five modules: Module 1 contains region-specific administrative information; Module 2 contains overviews and summaries of nonclinical, clinical and quality information; Module 3 contains chemistry, manufacturing and control (CMC) information; and Modules 4 and 5 contain nonclinical and clinical study reports, respectively. Sponsors are required to follow the Comprehensive Table of Content Heading and Hierarchy that is updated regularly by the agency.
- This requirement includes the submission of certain promotional materials to the FDA electronically. Promotional materials submitted following FDA approval should include FDA Form 2253 along with the proposed promotional material under Module 1.15 of the eCTD. The most recent FDA Form 2253 was updated in October 2021.
- The FDA’s Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) respectively regulate pharmaceutical advertising, including direct-to-consumer advertising. In general, OPDP and APLB are concerned with upholding FDA regulations that advertisements must be truthful, non-misleading, include important information about a product’s benefits and risks, and that information is presented in ways that make the advertisement comprehensible to its intended audience. These Offices also review promotional materials submitted to the Agency.
- In 2015, the FDA published draft guidance entitled “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs”for manufacturers, packers, and distributors that may file promotional materials for review. The draft guidance was finalized in 2019 following a handful of comments from industry.
- This week the final guidance was slightly revised. The guidance underwent a level 2 revision – i.e., it contains only minor changes or discusses an already existing policy. According to the update, draft promotional materials submitted to APLB should use Form 2253, which contains a check-mark box “For CBER products only,” which should be selected.
- Table 1 of the final guidance is updated to reflect 503C television advertisements as a submission type. The update notes that 12 paper copies should be submitted to OPDP while APLB only requires 2. If a video is provided, one copy is sufficient. 503C refers to a section of the FDA Amendments Act which required OPDP to receive the TV advertisement at least 45 days in advance of the advertisement first airing.
- The update also includes an email address for OPDP reviewer assignments. This is because certain products may be approved for several indications, but promotional material should be submitted separately for different indications. Previously, the guidance did not include contact information and provided a link for information on OPDP reviewer assignments based on therapeutic area.
To contact the author of this analysis, please email Kedest Tadesse.
- Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs – Finalized 07/2019
- Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs – Revised 04/2022