Very Brief Blog: FDA Guidance on Payor Communications

Here's one for your horizon scan.  FDA has posted draft guidance updating its policies for communications with payors, such as HEOR information.

Here's my understanding.  FDA already had a guidance that covered marketed product (drug or device) communications with payors about 'health economics' that was not misleading.  

Recall that the starting point for FDA-regulated manufactuerers is what's literally on the FDA label, where HEOR usually isn't.

The old guidance was predicated in part on 502(a) and involved communications on approved products and indications.  There was some FDA "enforcement discretion" for unapproved products (pipelines).  

A 2023 bill adds 502(gg) which specifically extends by law some protections to unapproved (pipeline) products.   

The draft was released June 3 with 60-day comment to August 3.  Think of it this way: 

• Old 2018 final guidance + 2023 new law §3630 creating 502(gg) = this 2026 new draft guidance.

The comments docket is here.  The 24-page draft is here.

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Any number of articles about the draft are on Google here.  For extra credit, also check out the 2025 FDA guidance on unapproved uses of approved products here.