FDA Finalizes Guidance on Promotional Drug Labeling and Ads

Regulatory NewsRegulatory News
| 11 December 2017 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.

FDA said it received one comment on the revised draft guidance, and in addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised draft guidance and to provide examples illustrating prominence issues.

FDA further clarifies issues relating to the direct conjunction of the proprietary and established names, as well as the frequency of use of the established name on printed pages or spreads, in running text or columns, in the audio portion of audiovisual promotions and in electronic media.

The recommendations pertain to product names in print media promotional labeling and advertisements (e.g., journal ads, detail aids, brochures), audiovisual promotional labeling (e.g., videos shown in a health care provider's office), broadcast advertisements (e.g., television advertisements, radio advertisements) and electronic and computer-based promotions (e.g., internet, social media, emails, CD-ROMs and DVDs).

The agency on Monday also discussed the ways in which it will study how consumers and health professionals spot and report deceptive drug promotions and responded to comments.

For instance, one commentator said it's FDA's responsibility and not consumers or health professionals' responsibility to report such deceptive promotions. But FDA said that because sponsors are not generally required to submit promotional pieces to FDA prior to dissemination and limited resources prevent FDA's Office of Prescription Drug Promotion (OPDP) from reviewing all promotional materials in the marketplace, "it is critical that OPDP [Office of Prescription Drug Promotion] adequately understand the capacity of consumers and HCPs to detect false and misleading claims as well as these populations' processing of such claims."

FDA Commissioner Scott Gottlieb added in a statement: "A key to our oversight is recognizing claims in prescription drug promotion that have the potential to deceive or mislead consumers and health care professionals. We also need to have clear rules for how sponsors can present certain information, even elements as straightforward as the product name, and do so without introducing features that could mislead patients."

Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements Guidance for Industry  


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