FDA Making Changes to its Drug Advertising Review Process

Regulatory NewsRegulatory News | 22 April 2015 |  By 

A new guidance document finalized by the US Food and Drug Administration (FDA) proposes to make it easier for pharmaceutical marketing professionals to submit their advertisements and promotional materials for review by regulators.


At present, all pharmaceutical advertisements aired or distributed by companies must be submitted to FDA's Office of Prescription Drug Promotion (OPDP)—formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC).

The review process is intended to ensure that advertisements are truthful, not misleading, do not omit any material information and are presented in a fair and balanced way. Violations of these standards can result in a company being issued a so-called "Untitled Letter" outlining the ways in which an advertisement is deficient.

While some advertisements, such as for new drugs, must be submitted to OPDP prior to their first instance of marketing, most other advertisements and promotional materials are submitted to FDA at the time of marketing using Form FDA 2253.

According to 21 CFR 314.81(b)(3)(i):

The applicant shall submit specimens of mailing pieces and any other labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Mailing pieces and labeling that are designed to contain samples of a drug product are required to be complete, except the sample of the drug product may be omitted. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product's current professional labeling.

If an advertisement is insufficient, FDA may order the immediate withdrawal of the promotional piece from circulation or, for serious deficiencies, corrective advertising.

For more on the submission of Form FDA 2253, read this explanation on FDA's website.

Need for the Guidance

There's just one problem: While pharmaceutical companies might be using websites, emails and other electronic media to promote a drug, OPDP has traditionally required companies to submit these materials to it for review using Form FDA 2253—a paper-based form.

(Another of FDA's advertising review divisions, the Advertising and Promotional Labeling Branch of the Center for Biologics Evaluation and Research, has accepted electronic submissions).

Now, OPDP is proposing to change that.

In its new draft guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs, FDA is proposing to allow pharmaceutical companies to submit promotional materials for human prescription drugs to OPDP using its electronic common technical document (eCTD) format. The change was required under Section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA).

Two years after the guidance document is finalized, all companies will be required to submit their promotional materials to OPDP in electronic form, FDA's guidance explains. "As of that date, paper hard copies will no longer be accepted for such submissions," FDA wrote. In the meantime, firms are "strongly encouraged" by FDA to begin submitting promotional materials using the eCTD immediately.

The guidance document contains extensive comments regarding the content and format of all submissions. Comments on the guidance are due to FDA by 21 July 2015.


Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (FR)

Dale Cooke's Explanation of the Guidance


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