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.


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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

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References

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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 The Cardiology Advisor