Navigating Recent Off-Label Promotion Developments provides feedback from some of the nation's leading legal minds on staying up-to-date with current regulations and FDA enforcement practices.
Determining the allowances and limitations of off-label promotion has recently become more challenging with cases such as Caronia. Attorneys and clients alike are keeping tabs on what instances of off-label promotion are being scrutinized in order to remain in compliance and ultimately avoid prosecution. In light of this, key questions have been raised, such as:
- What is considered “off-label promotion”?
- What are the repercussions for those who violate government regulations?
- What role does the First Amendment play in off-label promotion?
- What impact have recent, noteworthy cases had on food and drug law as a whole?
- How are the rules governing off-label promotion changing?
- Has the FDA issued any additional guidance on the subject?
- What issues remain unclear, despite these recent developments?
In this title, experts discuss how to differentiate between what is classified as allowable, truthful, scientific information versus prohibited off-label promotion. Additionally, the authors give tips on ways to ease client concerns during this time of uncertainty. This report offers readers an on-the-spot look at this issue as it continues to unfold.
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