A great deal of material is generated in the marketing of a medical product, for dissemination across an increasingly broad range of media, including written materials, press releases, commercials (television, radio, or online), website content, and social media outlets such as Twitter, Facebook, and LinkedIn.
Messaging through these and other channels may use language in contexts other than the direct prescribing information for a product may inadvertently be misleading, misperceived, or in some way alter specific details from what is listed in the product approval labeling.
In January of 2017, the US Food and Drug Administration (FDA) released 2 sets of draft guidances1,2 designed to establish standards for communications about products that will parallel, at least in intent, the specific indications and claims that can be made in product labeling. The FDA will consider electronic or written queries and comments submitted before April 19, 2017 to the final guidance documents to be completed.
The first document titled “Medical Product Communications That Are Consistent With FDA-Required Labeling — Questions and Answers”1 is aimed at general promotional and marketing communications used by the manufacturing industry. The second, targeting communications prepared for decision-making bodies, is titled “Drug and Device Manufacturer Communications With Payers, Formulary Committees, and Similar Entities — Questions and Answers.”2
The intended audiences for both documents are drug, biological product, and device manufacturers, including packers and distributors and all their representatives, with specific attention paid to promotional and marketing materials and communications they may create and disseminate.
Medical Product Communications Consistent With FDA-Required Labeling
This Q&A document clarifies the main tenets of FDA objectives, that all communications about a product adhere to standards already determined for drug and device safety for human use, and that they do so in a manner consistent with FDA-labeling for that product. The guidance spells out 3 factors the FDA will use to determine consistency of communications in comparison to labeling:
(1) Language and information used to convey all conditions of approved use, including indication(s); patient population; limitations and directions for the handling, preparation, and application of product; and specific dosing and routes of administration approved;
(2) Potential for increased harm caused by representations or suggestions made in communications compared to labeling; and
(3) Whether communications accurately represent the conditions under which the product can be safely and effectively used.
The guidance document specifically states that communications cannot be used to provide evidence to expand the intended use for a product, even if it consistent with FDA labeling.
An article published in the National Law Review3 explains that even following the rules of consistency “is not enough to avoid enforcement action.”
Recommended methods to avoid “misleading” communications focus on both the need to accurately depict study results, data, information, and disclosing unfavorable or inconsistent findings in clinical trials reported in labeling. The guidance documents also focus on intention and context, suggesting that all information and data relevant to full perception of the context should be included.
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities
In recognition of circumstances in which manufacturers and developers may communicate with decision-making entities regarding access and value of their products, the FDA provided a second Q&A document to clarify expectations of propriety. The guidance notes that “FDA is aware that payors seek a range of information on effectiveness, safety, and cost-effectiveness of approved drugs, including information from firms to help support their drug selection, formulary management, and/or coverage and reimbursement on a population basis. This information may differ from and be in addition to the information the FDA reviews in order to make drug approval decisions.”
The goal of this document is to ensure that healthcare economic information (HCEI) provided in these circumstances is both “truthful and non-misleading” by remaining consistent with FDA-labeling. Specifically, the FDA recommends that all HCEI materials disseminated should include all aspects of the study design and methods of analysis, as well as study limitations, economic analysis, and sensitivity analysis, if applicable.
Where context was an important focus in general communications, the FDA specifically noted that communications to decision-makers need to “provide a balanced and complete presentation.” Including a statement of the FDA-approved indication along with a copy of the most current FDA-labeling upon submission is highly recommended.
Required components include a “conspicuous and prominent statement” describing any differences between language in the HCEI and labeling, and a disclosure of “any additional risk related to assumptions that vary from the approved labeling.” The FDA recommends full disclosure of risks associated with label use in HCEI materials as well.
Communications Regarding Investigational Products
The same guidance document also explored appropriate communications about products that have not yet been approved. Based on 2015 approvals, the FDA estimated that 520 manufacturing companies each send out approximately 1040 different communications to payors about their products prior to receiving approval. The guidance recommends that each piece of communication should include a clear statement that the product is under investigation and that “the safety or the effectiveness of the product has not been established.”
Range of Guidance Considerations
The intent of the 2 guidance documents is to provide consistency in both information and interpretation with FDA-labeling of the product itself across a fairly broad range of media, materials, and discussions about a given product from the earliest point of dissemination throughout its full marketing life.
To that end, the FDA will specifically review all types of communications associated with a product, including promotional material, social media, and marketing materials, as well as more closed communications to decision makers.
In addition to conforming to FDA guidance, all types of advertising are required under Food, Drug & Cosmetic (FD&C) Act (Title 21) to be truthful and non-misleading, and therefore must report all material facts about a product, including information on any risks to its use.4 The FDA guidance further stipulated that all data and analyses used to support representations made in communications or promotions must be derived from sources that are both “scientifically appropriate and statistically sound.”
An important feature of the 2 guidance documents is strength of supporting evidence for any representations made. In cases where the supporting data show limitations, this should be explained in the materials; however, instances of weakly-supported evidence may contribute to a conclusion of misleading communication by the FDA.
The main area these 2 guidance documents specifically do not address is product-labeling, as this is covered in full detail in the “Guideline for Drug Master Files.”5
- Medical product communications that are consistent with the food and drug administration-required labeling — questions and answers; draft guidance for industry. Federal Register 2017;82(12):6575-6576.
- Drug and device manufacturer communications with payors, formulary committees, and similar entities — questions and answers; draft guidance for industry and review staff. Federal Register 2017;82(12):6568-6571.
- Peeples-Dyer V, Pollard VT, Ryan MW, Burrows VK, McDermott W, McDermott E. FDA issues draft guidance on communications that are consistent with FDA-required labeling. National Law Review. January 27, 2017.
- US Food and Drug Administration. Federal Food, Drug, and Cosmetic Act (FD&C Act). US Food and Drug Administration Regulatory Information. Last updated October 5, 2015. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmetic
ActFDCAct/default.htm. Accessed February 9, 2017.
- US Food and Drug Administration. Drug Master Files: Guidelines. September 1989. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances
/ucm122886.htm. Accessed February 9, 2017.
This article originally appeared on Endocrinology Advisor