Industry groups, pharmaceutical companies and device makers responded to the FDA’s draft guidances on off-label communications. The comments primarily centered on the need to broaden the scope of information that can be communicated off-label and the audience the information can be communicated with.

Industry stakeholders are weighing in on the two draft guidances issued by the FDA outlining how drug and device companies can discuss off-label uses with payers in truthful and non-misleading ways, and ways that are consistent with FDA-mandated labeling. Among the comments was a suggestion by AbbVie that the guidances be combined and harmonized, and a request by BIO that the FDA modernize its enforcement focus to align with First Amendment jurisprudence.

Comments to the draft Q&A on communications with payers include:

  • AbbVie said the final guidance should make clear that an appropriate audience for communications includes individuals or committees that make population health decisions, and should broaden the examples of healthcare economic information that may be communicated.
  • Merck said the final guidance should be sure not to overly limit the definition of who healthcare decision makers are, and should allow flexibility in defining this group, as new decision makers may arise as the healthcare system changes. Merck also emphasized the need to recognize that the term “unapproved uses” includes not only unapproved products and unapproved indications, but also unapproved uses related to existing indications, such as differing duration of treatment.
  • In a joint submission, Eli Lilly and Anthem called for more clarity on whether pre-approval communications are viewed by the FDA as promotional, and said the guidance should provide flexibility to enable communication of information pertaining to new indications and line extensions, when such information is needed by payers for planning and forecasting.
  • AdvaMed said the communications described in the guidance should cover health systems’ budget or value committees and technology assessment committees, as they are commonly recognized and necessary entities in the medical device space. The industry group also calls on the FDA to add buyer committees and stakeholder coding committees to better reflect common entities that undergo review of medical technologies to make coverage and reimbursement decisions. AdvaMed also urged the FDA to distinguish between communications for drug makers and those for device companies.
  • PhRMA said FDA regulation of truthful and non-misleading information about FDA-approved products needs to carefully weigh the interests at stake with sufficient recognition of the level of sophistication of the audience. The industry group said the FDA should clarify in the final guidance that the term “investigational products” also applies to investigational uses of approved products. In addition, it says the FDA should make clear that the guidance applies to a healthcare provider when that provider is serving in the capacity of a formulary decision maker.

Comments on the draft Q&A on medical product communications consistent with labeling include:

  • AbbVie said the final guidance should remove any suggestions that the FDA intends to regulate scientific exchange as opposed to promotional communications, while elucidating how certain information may be communications when not supported by substantial evidence.
  • PhRMA said the guidance should make clear the guidance is limited to promotional communications and doesn’t apply to non-promotional scientific exchange. PhRMA also raised concerns about the evidentiary standard for medical product communications and called on the FDA to clarify that presentation of information consistent with the product’s labeling won’t be considered false or misleading so long as it is presented based on scientifically appropriate and statistically sound data and accompanied by sufficient disclosure of contextual information. It also suggested the FDA provide more guidance on the kind of data that would meet the “scientifically appropriate and statistically sound” standard.
  • BIO pointed out there are limitations in relying solely on approved product labeling for treatment information. It noted that payers need information that may not be available in the FDA-approved labeling, such as comparative data, and said real-world evidence, in order to support value-based purchasing. The industry group asked that the guidance make clear that scientific exchange is excluded, and that it applies only to advertising and promotional labeling.