FDA Issues Promotional Labeling Guidance

On Dec. 11, the U.S. Food and Drug Administration issued two Federal Register notices related to prescription drug promotion from the FDA Center for Drug Evaluation and Research’s Office of Prescription Drug Promotion.

The first Federal Register notice announces the FDA’s final guidance on product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. The disclosure of the product name in promotional materials is important for the proper identification of the products to ensure their safe and effective use.

The second Federal Register notice is related to an FDA proposal to study the ability of consumers and healthcare professionals to spot and report deceptive prescription drug promotion practices. The ability to spot deceptive prescription drug promotion in the marketplace has important public health implications. Patients may use information from drug promotions, such as information about a product’s efficacy and risks, when exploring treatment options and making treatment choices.

Likewise, healthcare professionals may consider information from promotional materials when making prescribing decisions. In cases where such information is false or misleading, consumers may ask for and healthcare professionals may prescribe specific drugs that they would not otherwise request or prescribe, respectively. Once completed, the proposed studies will provide data on whether consumers and healthcare professionals can identify claims as false or misleading, and whether they would be willing to report deceptive drug promotion to the FDA.

Although both studies will assess consumers and healthcare professionals, one study will focus on the degree of deception in an ad while the second study will focus on implied vs explicitly deceptive claims.

“Promotional material that drug makers share with patients and providers can be a helpful tool for encouraging patients to seek medical care and raising awareness about new and different treatment options,” says FDA Commissioner Scott Gottlieb, M.D. “The FDA plays an important role in helping to make sure these presentations are truthful, balanced, and non-misleading, and we need to study promotional material to constantly improve our oversight over these activities.

“A key to our oversight is recognizing claims in prescription drug promotion that have the potential to deceive or mislead consumers and healthcare 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. These new efforts are part of an ongoing policymaking process aimed at making sure our practices protect consumers and help ensure that the information provided to them is useful for protecting their health,” Gottlieb says.