FDA Permitted Off-Label Promotion of Regulated Products

Date: March 5, 2025
Time: 12 PM EST
Duration: 60 Minutes

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.

Topics Covered in the Session:

Current FDA accepted definition of off-label, in-label, published and anecdotal information
FDA guidance documents about off-label promotion
Review of case-studies from unsuccessful and successful promotion of off-label uses
Practical tips for training of sales and marketing teams in off-label uses of products
Regulatory strategies for converting off-label uses to in-label uses

Who will benefit:

This webinar will provide valuable information to:

Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies, Dietary Supplement manufacturers
Marketing and advertising professionals
Financial analysts and investors, venture capitalists, insurance professionals
Legal experts involved in advising manufacturers of marketed products
Senior management for companies developing new products for US market
Regulatory affairs professionals, research analysts

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.