Of particular interest to medical device and pharmaceutical manufacturers, the U.S. Food and Drug Administration (FDA) issued a highly-anticipated revised draft guidance on October 23, 2023. The guidance focuses on communications to health care providers (HCPs) regarding scientific information on unapproved uses of approved/cleared medical devices and pharmaceuticals. The draft guidance replaces the 2014 document, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices,” and presents revised recommendations in a question-and-answer format.

The Federal Food, Drug, and Cosmetic Act (FDCA) prohibits the introduction into interstate commerce of a medical product that is intended for a use that has not been approved or cleared by FDA. The agency, however, recognizes that HCPs may desire scientific information about unapproved uses of FDA-approved/cleared medical products to inform the treatment and care of an individual patient. If a firm (e.g., manufacturer) shares scientific information about an unapproved use with HCPs in a manner consistent with the guidance’s recommendations, FDA does not plan to use the communication alone as evidence of a new, unapproved intended use.

The draft guidance concerns the sharing of the following types of communications with HCPs:

• Published scientific or medical journal articles (reprints).
• Published clinical reference resources (clinical practice guidelines, scientific/medical reference tests, and materials from independent clinical practice resources).
• Firm-generated presentations of scientific information from an accompanying published reprint.

The draft guidance’s recommendations only apply to approved/cleared medical products, which include:

• Medical devices with an approved premarket application (PMA), 510(k) clearance, De Novo classification, or Public Health Service Act (PHSA) § 351 license.
• Medical devices exempt from premarket notification.
• Human drugs with an approved application under FDCA § 505 (small molecule drugs) or PHSA § 351 (biological products).
• Human drugs marketed in compliance with FDCA § 505G (over-the-counter drugs).
• Animal drugs with an approved application under FDCA § 512 (this does not include a conditionally approved or indexed animal drug).

According to the agency, the guidance “represents a continuation of FDA’s ongoing efforts to consider, develop, and refine its policies and recommendations relating to communications by firms about unapproved uses of their approved/cleared medical products.” Other recent FDA efforts include:

• The issuance of a January 2017 memorandum, “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”
• The publication of a June 2018 guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers.”
• The issuance of August 2021 final rule revising the “intended use” definitions for medical devices and drugs at 21 CFR §§ 201.128 and 801.4.

Interested parties have 60 days to submit public comments to FDA concerning the draft guidance under docket number FDA-2008-D-0053 at www.regulations.gov.