On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for industry: “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” This FDA guidance on firm-to-HCP communications for unapproved uses of products applies to human and animal drug products as well as medical device products. 

The FDA states in the preamble “This guidance describes FDA’s enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm’s approved/cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients.”  

The FDA intends to reassure firms that, if they follow the recommendations in this guidance, the Agency will not use the firm’s communication by itself as evidence of a new intended use, which could result in an enforcement action against the firm.  

The FDA is taking this enforcement approach to promote public health, recognizing that truthful and non-misleading scientific information about unapproved uses of the firm’s approved/cleared medical products can help HCPs understand and evaluate the suitability of using that product for their patient’s condition. The firm’s communication should appropriately present all information necessary for HCPs to understand and evaluate the strengths and weaknesses, validity, and clinical utility of the scientific information on unapproved uses of the product.   

Recommendations for firms sharing information from appropriate source publications and/or firm-generated presentations of scientific information on unapproved use(s) provided with a source publication are also provided. Examples of appropriate source publications include:  

• Reprints of published scientific or medical journal articles 
• Published clinical reference resources such as clinical practice guidelines (CPGs), scientific or medical reference texts, or materials from digital clinical practice resources. 

The firm-initiated communications to HCPs, in combination with the disclosures recommended in this guidance, are referred to as “Scientific Information on Unapproved Use(s) of approved/cleared medical product communications” (“SIUU communications”). 

Key Points of Guidance 

The key points of the guidance are: 

Section I Introduction explains FDA’s enforcement policy which is attempting to strike a balance between the competing public health interests of prevention of illegal promotion of off label uses and providing HCPs with accurate scientific information to inform clinical practice decisions for the care and management of their individual patients.   

Section II Glossary defines the terms used in the guidance. Two key definitions to note are “SIUU communication” and “Unapproved use.” 

SIUU communication refers to a firm-initiated communication of scientific information on unapproved use(s) of the firm’s approved/cleared medical product that:  

1. 1. Is shared with HCPs engaged in prescribing or administering approved/cleared medical products to individual patients, and  
   2. Includes the disclosures recommended in this guidance, and  
   3. Includes one or more of the following types of source publications:  
      • Published reprints  
      • Published clinical reference resources (CPGs), as follows: 
        • Reference texts  
        • Materials from digital clinical practice resources  

An SIUU communication can also include a firm-generated presentation. 

Unapproved use refers to a use that is not lawfully included as an indication or use in the FDA-required labeling of an approved/cleared medical product. 

Section III Background explains how the medical product regulation in the United States has been shaped by experience to protect the public from medical products not shown to be both safe and effective. FDA authorities prohibit the introduction into interstate commerce of a medical product that fails to comply with applicable premarket requirements or is otherwise misbranded or adulterated. This includes any medical product intended for a use not approved (an unapproved use), even if approved by FDA for a different use.  

Appropriate intended uses can be established from the medical product’s label, labeling, promotional claims, advertising, and any other relevant source which were approved/cleared by the FDA in the premarket review process. After the premarket review process is complete and a product is approved/cleared, questions may arise in clinical practice relating to the use of the medical product for patients.  

It is accepted practice for HCPs to prescribe and use approved/cleared medical products for unapproved uses when the HCP believes the use is medically appropriate. For example, the HCP may be treating a patient with a disease for which there is no medical product that is a proven treatment or in a patient who has exhausted all medical products which are approved for their disease. In such instances, HCPs need information about unapproved uses of approved/cleared medical products that might help their patient.   

The guidance aims to prevent patient harm that could result from information that is false, misleading, or fails to provide and appropriately present all the information necessary for HCPs to understand and evaluate the strengths and weaknesses, validity, and clinical utility of the scientific information on unapproved use(s).  

Understanding these factors, the FDA has attempted to strike a balance between providing HCP helpful information to inform their practice of medicine without undermining other interests. Some of these other interests are incentivizing the development of medical products, satisfying the applicable premarket requirements for medical products, and protecting patients from products that have not been shown to be safe and effective.   

The predecessor documents that this guidance replaces include: 

• Draft guidance of the same title issued in October 2023 (88 FR 73031) 
• Draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices,” issued in March 2014 (79 FR 11793) 
• Final guidance entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” issued in January 2009Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” issued in January 2009 

Section IV Policy expounds on the criticality that SIUU communications be truthful and non-misleading. They must provide and appropriately present all information necessary for HCPs to understand and evaluate the strengths and weaknesses, validity, and clinical utility of the scientific information on unapproved use(s) in the SIUU communication. The FDA does not intend to use the firm’s dissemination of an SIUU communication standing alone as evidence of the firm’s new intended use of the product if the communication is consistent with the recommendations in this guidance.  

The Agency provides numerous recommendations in this section. Our advice is to review this section thoroughly while preparing the SIUU communication and again right before conducting the communication to ensure only current and complete scientific information is provided. This is especially important for any firm-generated presentations.   

One key thing to note is that nothing in the guidance is intended to be a new policy regarding a firm’s existing obligations to update FDA-required labeling to reflect current knowledge about the safety profile of the drug and that the labeling is not false or misleading. 

Section V Questions and Answers are discussed further in this piece: “Understanding Recent FDA Guidance on Firm-to-HCP Communications: Questions & Answers” 

Section VI Paperwork Reduction Act of 1995 explains the last step before the guidance is fully implemented. The FDA requests written comments on the burden of the collection of information required by this guidance by February 21, 2025.   

Adhering to FDA Guidance on Firm-to-HCP Communications Regarding SIUU 

We suggest that firms adopt the recommendations of this guidance and build them into their quality system. You can start by creating a policy document that says your firm will abide by these guidelines, and then supplement the policy with standard operating detailing how you will implement the recommendations. Finally, it’s advised to set up enabling work instructions with forms to provide checklists ensuring the firm’s SIUU communications to HCPs meet the guidelines. 

Clarkston has experience helping firms navigate the complexities of FDA regulations within the medical device space and the larger life sciences sector. If you have questions about the FDA’s recent guidance on communicating SIUU to healthcare providers – or if you need support implementing the requirements from this guidance – our team can help. Contact us today.