FDA Updates Draft Guidance on Drug Cost Talks
Published Date: 6/3/2026
Notice
Summary
The FDA just released a revised draft guide to help drug and device makers share important cost and coverage info with insurance companies and similar groups. This update clears up how to talk about approved products, unapproved products, and new uses, making it easier for everyone to understand the rules. Companies should send their feedback by August 3, 2026, so the FDA can finalize the guide—potentially speeding up coverage decisions and saving money.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Paperwork Burden: 210,561 Annual Hours
FDA estimates the revised guidance’s recommended disclosures will result in 12,960 total annual disclosures and 210,561 total annual burden hours across firms. Examples in FDA’s estimate: about 600 manufacturers producing 7,800 HCEI materials for approved prescription drugs (20 hours each); about 260 manufacturers producing 2,600 HCEI materials for approved/cleared devices (20 hours each); unapproved-product communications and follow-ups use 0.5 hours and 2 hours per disclosure respectively. FDA also reports an overall increase of 7,883 hours and 472 disclosures in its estimate.
Safe Harbor for HCEI on Approved Products
If you are a drug or device manufacturer, FDA’s revised draft guidance says health care economic information (HCEI) you give to payors about FDA-approved or cleared products will not be considered false or misleading if it (1) relates to an FDA-approved indication, (2) is based on competent and reliable scientific evidence, and (3) includes, when applicable, a conspicuous statement describing material differences from FDA-approved labeling. This is a revised draft guidance that, when finalized, will replace the June 2018 guidance.
Safe Harbor for Unapproved Product Information
If you are a drug or device manufacturer, FDA’s revised draft guidance explains that under section 502(gg) certain truthful and not-misleading communications to payors about investigational or unapproved medical products or investigational uses of approved/cleared products will not cause the product to be treated as misbranded under section 502(f)(1). The guidance states such communications must meet the statutory criteria in section 502(gg) (e.g., be the type of product information defined in 502(gg)(2) and be presented with the information set forth in 502(gg)(1)(A)).
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