FDA finalizes guidance on promotional drug labeling and ads

FDA has finalized guidance from 2013 on prescription drug product name placement, size, prominence, and frequency in promotional labeling and advertisements for prescription drugs.

FDA has finalized guidance from 2013 on prescription drug product name placement, size, prominence, and frequency in promotional labeling and advertisements for prescription drugs. The guidance has been revised to clarify 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. FDA also discussed ways in which it will study how consumers and health professionals report deceptive drug promotions and responded to comments. "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," said FDA Commissioner Scott Gottlieb. "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."