Does FDA Guidance About Pharma Communications with Payors Open a Path to Off-Label Discussions?

At the November, 2016, FDA public hearing on off-label promotion, representatives of the drug industry made a case for allowing companies to inform payers of off-label uses of their products.

Payers “play such a gatekeeping role with respect to patients,” said Kellie Combs, an attorney for Ropes & Gray, who testified at the hearing on behalf of the Medical Information Working Group. “There's a real interest in getting information to payers as soon as possible.”

In addition, certain types of data, like demonstrating a drug's use in subpopulations and sharing pharmacoeconomic data, are examples of information that do not meet the FDA's criteria but are still valuable to payers, said Dr. Sandra Milligan, SVP of global regulatory affairs and clinical safety at Merck (see MM&M report here).

At the time, I asked “Will FDA Open a Path to Off-Label Promotion from Pharma to Payers & Not Patients or Providers?” (op cit). It appears that the path is now opening up, at least for drug companies to communicate “health care economic information” (HCEI) regarding their prescription drugs to payors. This opening is laid out in new draft guidance form the FDA titled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers” (find it here).

Here are some excerpts from this guidance…

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