• Rick Bartels, MBA

New FDA Payer Communication Guidance

By: Rick Bartels, MBA


One of the most effective methods to provide payer organizations with information about a new products prior to FDA approval is to talk to them directly.


I often hear pharma companies express concern about engaging in payer discussions prior to approval, but the reality is the FDA is in favor of pre-approval payer communications. In fact, the FDA recently released guidance on payer communications for the pharma industry.


According to the guidance on payer communications, pharma companies can share unapproved product and use information with payer organizations as long as they clearly state:

1) The product or use is not approved

2) The product's status in the FDA approval process

3) Details of studies used to test the product


Benefits of pre-approval communication for pharma manufacturers:

- Increased business relationship with payer organization

- Gain payers' perspective on utilization management

- Understand payers' perspective on the competitive landscape within the market

Benefits to the payer:

- Increase awareness of new products

- Payer may delay extending competitive product contracts based on knowledge of a new product coming to market

- Enhances payer/manufacturer relations


Schooner consulting, LLC

Managed care and Market Access Experts

610-533-2118

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