Current FDA Voluntary Pre-Publication Rx Ad Review Processes

As run-up to FDA’s DTC Prescription Advertising Rule that goes into effect on May 20, 2024, CHC is working with FDA staff to help reinforce current ad review processes available to healthcare marketers and how review of ads will change in May and later this year with its November enforcement date.

Watch for our planned April webinar with FDA staff to learn more and ask questions on this new regulation. If new to these advisory review processes, CHC is providing these opportunities as there is a lot of dense regulatory information, especially in the submission guidance.

A good introduction to the rule for anyone is FDA’s Small Entity Compliance Guide (SECG) for the DTC Rx Ad Final Rule – a Q and A format guide in plain language that addresses the requirements of the new regulations.

FDA currently provides a voluntary opportunity to submit prescription drug promotional materials for advisory comment before the dissemination or publication. Agencies and/or pharma manufacturers (typically done to date with large national TV ad spends) may request advisory comments on draft promotional materials and receive comments in writing from the FDA Office of Prescription Drug Promotion. Explaining how FDA expects promotional communications to be submitted to the agency can be found in the guidance: Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs.

  • Section IV (beginning page 5) discusses the requirements firms have to submit all promotional materials to the. The requirement is that the submission occurs at the time of initial publication. For these submissions, you’ll be using Form FDA 2253 and the Form FDA 2253 Instructions Supplement.
  • Please note that discussion of Direct-to-Consumer TV ad advisory comment requests (beginning at the bottom of page 10).

Again, watch for announcements about our planned April webinar with FDA staff on the DTC Rx Ad Final Rule implementation and Q&A session.

For questions about the FDA’s final rule on direct-to-consumer (DTC) prescription drug advertisements, please contact Jim Potter, CHC Executive Director at