The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific informationon unapproved uses of approved/cleared medical devices and pharmaceuticals. The draft guidance replaces the 2014 document, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices,” and presents revised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.
https://www.fda.gov/media/173172/download
As specifically noted by the FDA, dissemination of scientific information on unapproved uses (SIUU) information in accordance with the new guidance would not be the only way that companies may engage in communications regarding unapproved uses of approved products. Companies may still avail themselves of the FDA’s guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, Industry-Supported Scientific and Educational Activities, and Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities (and associated statutory provisions).
The FDA further states, “it has long been FDA policy not to consider a firm’s presentation of truthful and non-misleading scientific information about unapproved uses at the planned sessions and presentations at medical or scientific conferences to be evidence of intended use when the presentation is made in non-promotional settings and not accompanied by promotional communications.” Accordingly, the SIUU guidance would provide companies with an additional avenue to communicate scientific information to the medical community.
Notably, in some ways, the draft SIUU guidance would expand the scope of information on which firms would be able to rely when disseminating information regarding unapproved uses of approved products. Unlike the FDA’s prior guidance on the dissemination of reprints that required that studies be well-controlled clinical investigations, the SIUU guidance provides for other kinds of studies so long as they are scientifically sound and clinically relevant. This, however, would require firms to assess whether the new FDA standard is met for source publications and firm-generated material. It also would require firms to periodically reassess source publications to confirm that they continue to meet FDA standards (e.g., to confirm that there have not been any new findings that may undermine a publication’s clinical relevance). This would require that companies establish processes to scientifically and clinically assess source publications, both initially and following initial approval of a publication’s use.
In other ways, however, the SIUU guidance may be intended to restrict the scientific information that may be disseminated by companies. Under the FDA’s regulations and the agency’s long-standing policy, the agency does “not intend to restrict the full exchange of scientific information concerning [a] drug, including dissemination of scientific findings in scientific or lay media.” This did not rule out the presentation of internally generated data that may not yet be published.
Further, under the SIUU guidance, companies with approved products that intend to disseminate SIUU information may only rely on published scientific or medical journal articles and clinical reference resources to fit within the FDA’s communicated enforcement policy. This would not, notably, include unpublished data on file.
Finally, while not explicitly stated, the SIUU guidance would clarify the question regarding whether information on unapproved uses that are disseminated in the form of reprints and clinical practice resources, and other presentations based on the same, may be proactively distributed by a company or whether they may only be distributed in response to an unsolicited request for information, an area that has historically raised questions within the industry.
Based on the guidance’s discussions regarding posting SIUU information to company websites and dissemination via social media, the FDA appears to settle this question by indirectly stating that SIUU information that complies with the guidance may be proactively communicated
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