Off-Label Drug Promotion - Webinar CD/Transcript
Off-Label Drug Promotion: FDA’s Recent Enforcement in the Product Promotional Arena
The FDA allows manufacturers to engage in off-label communications under certain circumstances including: responses to unsolicited requests — through sponsorship of continuing medical education events where off-label uses are discussed — peer-reviewed journal articles — medical texts — and clinical practice guidelines containing off-label information.
Recently, the FDA’s authority to restrict off-label communications has been successfully challenged in a series of court decisions suggesting that companies may distribute truthful — non-misleading information — about off-label uses of their products without violating the FDCA.
On Nov. 9-10, 2016 the FDA held a public hearing on manufactures ability to communicate information about unapproved uses of medical products that have at least one approved or cleared indication — or “off-label communications.”
Legal expert Alan Minsk — of Arnall Golden Gregory — discusses the FDA’s latest rules on what speech is and is not protected.
In this 1-hour session you will learn about:
- FDA’s enforcement against pre-approval promotion
- The PhRMA/BIO principles on sharing truthful and non-misleading information
- FDA's recent public hearing on off-label communications
- Non-FDA-related issues to consider with off-label promotion
- A look ahead to where might we be headed
Order today and learn about how you can promote off-label uses of your drug while remaining compliant with FDA regulations.