FDA Final Guidance Documents on Communication Issues Improve Clarity

June 14, 2018 – Although they may not be perfect, the two final guidance documents issued this week by the FDA do provide more information and examples to help pharma companies navigate how they communicate with payors and how they ensure that their on-label communications are compliant. In a June 12 statement, FDA Commissioner Scott Gottlieb, M.D., noted that the agency seeks to help the healthcare industry harness “big data” and help establish the value of medicines.

“To advance these goals, the FDA is issuing updated, final guidance documents that provide greater clarity about our thinking and recommendations for certain medical product communications,” Gottlieb explained. “In particular, this guidance will inform market participants developing contracts that include value-based arrangements how to communicate information about how a drug might impact outcomes that are important to purchasers like a health plan or hospital, but is not an endpoint that is expressly described in the drug’s approved labeling,” according to the statement.

The report card on these guidance documents is relatively positive. “The changes to the guidance documents are extensive but generally favorable, providing additional clarity and flexibility for manufacturers to convey certain types of product information,” according to Kellie B. Combs, Ropes & Gray LLP. “Taken together, they demonstrate the agency’s belief that there is a variety of information not contained in product labeling that is nevertheless valuable to payers, prescribers, and patients,” she told the Coalition for Healthcare Communication.

APCO Senior Director Wayne Pines told the Coalition that “it’s great that the FDA has finalized these two important documents and that the agency clearly took into account the various comments that it received.”

The final guidance on “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities” ( provides answers to common questions and answers regarding firms’ communication of health care economic information about their products. “The payor communications guidance … now permits manufacturers to share information with payors about unapproved uses of marketed products, helping to ensure that payors have accurate, comprehensive, and up-to-date information about the safety, effectiveness, and value of a particular product,” Combs noted.

This payor guidance “will be especially valuable to manufacturers in providing something of a safe harbor when communicating with payors,” Pines said. “This has been an area of uncertainty for some time, but increasingly the communications with payors are taking on more importance as value-based judgments are made about drugs and devices.  There are now clearer differences from FDA’s perspective between promotional materials for HCPs and patients, and information supplied to payors.”

The final guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling” ( provides information for firms about how FDA evaluates firms’ medical product communications that present information that are not contained in the FDA-required labeling but still are “consistent with” that labeling.

This guidance “provides a number of additional examples for manufacturers to consider when developing their product communications, as well as clearer guidance on whether a product communication is appropriately substantiated,” Combs stated.

The final version “increases clarity and that’s a good thing,” said CHC Executive Director John Kamp. “But, it’s very, very narrow guidance and doesn’t touch the topic of off-label use,” he remarked. “That’s a disappointment.”

Bottom line, Pines said, “It is now up to the companies to exercise good judgment and responsibility in reaching out to payers within the confines of the new guidance. The same principle applies to the use of information that is consistent with the labeling and the guidance provided by FDA.”