April 22, 2015 – Healthcare marketers soon will have to submit promotional labeling and advertising materials to the FDA electronically, according to a draft guidance document announced by the FDA in today’s Federal Register.
That document, “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs,” explains how manufacturers, packers and distributors that either are the applicant or are acting on behalf of the applicant should make those submissions using Module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file (CDER040615draft).
The FDA states that it is issuing the draft guidance pursuant to a requirement included in the FDA Safety and Innovation Act (FDASIA). Several draft guidances were issued previously on electronic submissions, but the new draft guidance “provides additional information regarding the format to be used for electronic submission of promotional labeling and advertising materials using eCTD.” The guidance states that 24 months after the guidance is issued in final form, firms will be required to submit materials electronically and paper hard copies “will no longer be accepted.”
Specifically, the draft guidance addresses:
- Content for specific types of submissions;
- Format for submission of promotional materials in paper hard copy;
- Format for submission of promotional materials electronically; and
- Presentation issues.
The presentation issues section addresses how firms can ensure that electronic images adequately convey the net impression of the promotional piece or the details of the intended promotional message within the piece. Considerations in this area include visibility of text and images, concise description of use, layout indicators, Websites and other electronic formats, materials requiring manipulation by the end user, three-dimensional materials, multi-page spreads, kits and dimensions.
This section also includes seven examples of “appropriately submitted promotional materials.” One of these examples states: “A firm creates a website for a new product that includes links and videos. As part of its postmarketing requirements, the form must submit an electronic version of the product website under cover of Form FDA 2253. The website should allow the FDA reviewer to click on links within the website and view videos or other animation as an end user will experience while using the site. If the firm is unable to provide active links within the electronic submission, the firm should provide electronic images of each webpage in conjunction with videos.”
This example also includes a footnote stating that “A fully functioning website should be submitted in an accessible format whenever possible. Firms should not send links to websites – even if they are password-protected.”
Although the FDA has not yet launched the version of Module 1 that will be able to accept promotional materials sent to the OPDP, “the Agency expects to launch in the near future,” according to CDER, likely “within the 3rd Quarter of FY 2015.” CDER advises applicants preparing for electronic submissions to “work with us closely and submit samples for validation.”
The agency requests that comments on this draft guidance be submitted by July 21, 2015.