FDA Allows Off-Label Promotion, Sort of.
[Posted on: Thursday, June 21, 2018] In two new Guidance documents released this week, FDA presents a detailed explanation of its requirements for advertisement of approved products. In a slight policy shift, FDA walks away from the rigid enforcement of approved labels and provides some flexibility in marketing communications, while maintaining its control over new uses of approved products. The Guidance documents formalize an unofficial policy that has existed for the last few years. Manufacturers have always been allowed to expand on the FDA approved labels so long as the new information is truthful and non-misleading. However, lacking a final guidance, most marketing practices have been subject to interpretation and litigation. Any promotional material used for the marketing of an FDA-approved product requires vetting by the FDA. But often the approved material is limited by space and the details of the information included in the label. The market approval application for the product, for example, may include several non-clinical and clinical studies that were not pivotal and hence not included in the label. Or the details of the information about the pre-market studies may be limited in the FDA approved label. However, such information may be useful for the promotion of the product to patients and prescribers. FDA now officially allows all such truthful and non-misleading information, that was not included in the approved labels, to be used in marketing materials. Further, such “off-label” information can also be used in communications with the insurance companies and other payors who in turn may use such information to make coverage decisions. The Guidance documents use Q&A format and examples to explain the flexibility available under the current rules while maintaining policies consistent with past decisions. The Guidance document on FDA-permitted communications clarifies that information that was used in the market approval application but not included in the approved label such a preclinical studies, early phase studies, and even post-market data can be used in advertisements and promotions. However, the new information must not add new uses, new populations or any other major changes to the product information that would normally require pre-approval from the FDA. So, while some off-label information is permitted, manufacturers still are not permitted to discuss new clinical trials, new information obtained from independent publications or real world clinical experience to add substantial changes to the product information without FDA approval.
|
|