FDA Permitted Off-Label Promotion of Regulated Products
FDA recently released a couple of guidance documents updating its rules for promoting off-label uses of approved products in the light of FDA’s recent legal losses. FDA has publicly acknowledged that many regulated products have uses beyond what they have been approved for. FDA also recognizes that these unapproved uses may be beneficial to some patients. The so-called off-label uses may be well-known to the physicians and manufacturers. While there are no restrictions on a physician prescribing off-label uses of a product, manufacturers are prohibited for “actively” promoting an off-label use. These new clarifications of FDA’s enforcement discretion for manufacturers making off-label claims were long expected but still strictly limit what is allowed and what is not. The new requirements are similar to existing strategies that evolved after the legally discussions regarding off-label uses of FDA-approved products. This slight shift in FDA’s rules could have a major impact on the measures taken by manufacturers to educate physicians and even patients about new uses of their products. This seminar will discuss the regulatory perspective on promoting off-label uses for manufacturers.
Why should you attend:
If you market FDA-regulated products and have truthful and non-misleading new information for your products, you are now allowed to discuss these new uses without the fear of FDA finding you at fault or a frivolous law suit. However, before you start promoting all uses of your products, on-label and off-label; you must understand the limitations of the new rules. The new rules are not a carte blanche from FDA to manufactures to go around the formal approval process; rather it establishes the limits on both FDA and manufacturers per the new legal environment. This seminar will discuss the current FDA requirements for sharing off-label information with doctors and even patients and their impact on marketing of FDA-regulated products by manufacturers.
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