FDA Guidance on Product Communications: New Possibilities for Value-Based Marketing


Two important FDA guidance documents show how pharmaceutical, medical device and biologic companies can communicate effectively with insurers, formulary committees and other entities critical to establishing the real value of medical products through pricing and reimbursement decisions.

Importantly, the guidance offers a blueprint on how companies can communicate information about a product’s health outcomes that may not be expressly described in its approved labeling.

The guidance can also help companies communicate truthful, non-misleading information about their unapproved products or about unapproved uses of their approved or cleared products — to help secure coverage for the new products and uses soon after they’re approved or cleared by the FDA.

This Thompson whitepaper shows you how to present the measures of your medical product’s value that matter most to patients, purchasers and insurers — ensuring that your pricing reflects the full value of the outcomes your product delivers.

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