Jan. 27, 2017 – The FDA issued draft guidance last week that is designed to help medical product manufacturers understand how the agency evaluates product communications, including promotional materials, that present information not contained in the FDA-required labeling but that may be “consistent with” that labeling.
“We are aware that firms have questions about how FDA determines when such communications are consistent with the FDA-required labeling, and how they are viewed by FDA,” the agency states in the Jan. 19 Federal Register notice announcing the document’s availability.
The notice also states that although a firm’s communications that are consistent with the required labeling will not “alone be considered evidence of a new intended use,” “representations or suggestions made about the product would misbrand the product and could subject forms to enforcement action if [these statements] are false or misleading.”
The question-and-answer format of the draft guidance spells out the following:
- How the FDA determines whether the communication is consistent with FDA-required product labeling and how the FDA views this communication
- What types of information are considered consistent with the FDA-required labeling
- What types of information are not considered consistent with FDA-required labeling
- What evidentiary support firms should have to support its communications
- What other considerations apply to communications that are consistent with FDA-required labeling
- What the FDA recommends firms consider when developing these types of communications so their materials are not considered false or misleading
- Examples of communications that would be considered inconsistent with FDA-required labeling
- What the agency’s policies are for communications that are not consistent with FDA-required labeling
The draft guidance also would impose a reporting burden on the industry as part of the “third-party disclosure” recommendations, which call on firms to disclose various aspects of study design and methodology for studies relied upon in order to provide material contextual information. Material limitations related to the study design, methodology design and results “also must be disclosed in a clear and prominent manner to help ensure that the communications are false and not misleading,” and should include disclosure of “unfavorable or inconsistent findings,” the agency states in the notice.
The draft guidance also stipulates that disclosure of material limitations of the study relied upon for communication claims “does not correct the misleading message conveyed by the communication.” The reporting burden for this recommendation is estimated at four hours per disclosure.
“This new disclosure requirement is unnecessary,” according to Coalition for Healthcare Communication Executive Director John Kamp. “I don’t think it will survive in the new administration.”
The FDA is accepting comments on this draft guidance by April 19. To view the document, go to: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537130.pdf