On December 11, 2017, the United States Food and Drug Administration (FDA) published two Federal Register notices regarding prescription drug promotion from the FDA’s Center for Drug Evaluation and Research (CDER) Office of Prescription Drug Promotion (OPDP).
Final Guidance on Promotional Labeling
The first notice announces the FDA’s Final Guidance on product name placement, size, prominence, and frequency in promotional labeling and advertisement for prescription drugs (human and animal), including prescription biological products. The FDA believes that the disclosure of the product name in promotional materials is important for the proper identification of the products to help ensure they are used safely and effectively.
The recommendations in this guidance relate to product names in traditional print media promotional labeling and advertisements such as journal ads, detail aids, brochures; audiovisual promotional labeling, such as videos shown in a health care provider’s office; broadcast advertisements (e.g., television advertisements, radio advertisements); and electronic and computer-based promotions such as internet, social media, emails, CD-ROMs, DVDs). In this guidance, 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.
FDA recommends that the established name be placed either directly to the right of or directly below the proprietary name. FDA also recommends that the proprietary name and the established name not be separated by placement of intervening matter that would in any way de-emphasize the established name of the product or obscure the relationship between the proprietary name and the established name.
When it comes to the prominence of the proprietary and established names of a product with one active ingredient, the regulations require that “the established name shall have a prominence commensurate with the prominence with which such proprietary name or designation appears, considering all pertinent factors, including typography, layout, contrast, and other printing features.” Generally, FDA considers all methods used to achieve prominence in promotional labeling or advertisements when evaluating whether the established name is presented with a prominence commensurate with that of the proprietary name.
Additional regulations and guidance can be found in the document, including recommendations for products with two or more active ingredients.
FDA’s Proposed Project on Deceptive Presentations
The second 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, health care 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 health care professionals may prescribe specific drugs that they would not otherwise request or prescribe, respectively.
The studies will be conducted concurrently and will focus on different health conditions. Each study will be administered to two separate populations (i.e., HCPs and consumers affected by the condition). HCPs will view mock pharmaceutical websites targeted toward physicians and consumers will view mock consumer-targeted pharmaceutical websites. The goal will be to keep the HCP and consumer-targeted websites as similar as possible, but to include content that is appropriate for the target audience. For example, HCP websites may contain medical terminology, whereas the consumer websites would utilize consumer friendly language. A professional firm will create all mock websites such that they are generally indistinguishable from currently available prescription drug websites.
Study 1 will sample consumers who self-report chronic pain that has lasted at least 3 months and HCPs whose primary medical specialty is either primary care or internal medicine and whose responsibilities involve direct patient care at least 50 percent of the time. Study 2 will sample consumers who self-report obesity, defined as body mass index greater than or equal to 30 and include the same types of HCPs as study 1.
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, the first study will focus on the degree of deception in an ad while the second study will focus on implied versus explicitly deceptive claims.
Any comments should be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-New and title “Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.” Also include the FDA docket number: FDA-2016-N-4487.