The US Food and Drug Administration (FDA) in December 2017, issued guidance for industry on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs1.
This guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for prescription drugs. The disclosure of the product name in promotional labeling and advertisements is important for proper identification and to ensure safe and effective use. This guidance also articulates the circumstances under which FDA intends to refrain from taking enforcement action regarding these requirements.
The recommendations in this guidance pertain to product names in traditional print media promotional labeling and advertisements (e.g., journal advertisements, 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, DVDs).
In this guidance, FDA has further clarified 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 Commissioner Scott Gottlieb said that "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. 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". He further said, "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. 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" 2.
The FDA has also released a Federal Register Notice, concerning FDA's 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, health care professionals may consider information from promotional materials when making prescription decisions. In cases where such information is false or misleading, consumers may ask for and health care 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 health care 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 health care professionals, one study will focus on the degree of deception in an advertisement while the second study will focus on implicitly vs explicitly deceptive claims3.
Footnotes
1 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM375784.pdf
2 https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm588419.htm
3 https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-26704.pdf
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