Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request
Published Date: 1/7/2025
Notice
Summary
The FDA just released final guidance on how companies can share scientific info about unapproved uses of approved medical products with health care providers. This update affects medical product firms and aims to clarify communication rules, but it won’t take effect until the Office of Management and Budget reviews the info collection by February 21, 2025. No new costs yet, but companies should get ready to follow these clearer, friendlier rules soon!
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Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
FDA reassurance on SIUU communications
The FDA issued final guidance (announced January 7, 2025) explaining its enforcement policy for firm-initiated scientific communications about unapproved uses of approved or cleared medical products to health care providers. The guidance says that if firms follow the recommendations in the guidance, FDA does not intend to use the firm's dissemination of such communications alone as evidence of a new intended use.
Required SIUU disclosures and paperwork burden
The guidance recommends specific disclosures firms should include when sharing scientific information on unapproved uses (SIUU communications) and FDA submitted the associated information collection for OMB review under control numbers 0910-0686 and 0910-0485. FDA estimates, for drug firms (OMB 0910-0686) 747 firms may each share 30 SIUU communications annually (2.5 hours per disclosure), totaling 129,231 disclosures and 56,249.1 hours per year; for device firms (OMB 0910-0485) 261 firms may each share 30 SIUU communications annually, totaling 45,153 disclosures and 19,653.3 hours per year.
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