FDA's off-label trap: 7 reasons for uncertainty

In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns raised by regulatory agencies such as the FDA, DOJ, FTC, and OIG. The discussion revolves around the risk-based review of outward-facing information shared by medical device companies. The podcast delves into seven hierarchical layers that dictate how organizations should approach compliance. These layers include:

1. The Constitution (First Amendment): Highlighting the clash between First Amendment rights like free speech and FDA regulations. Emphasizes the importance of truthful and non-misleading information.

2. Laws Made by Congress: Discussing how laws such as the Food, Drugs, and Cosmetics Act set the rules but can be ambiguous, potentially leading to regulatory challenges.

3. Regulatory Agency Interpretation: Exploring how FDA, FTC, and OIG interpretations through regulations, guidances, and enforcement actions add another layer of compliance focus for Pharma companies.

4. CIA Settlements: Examining Integrity Agreements or CIA settlements as legal precedents that set industry wide regulatory expectations for Pharma companies.

5. Industry Codes: Discussing voluntary codes like Pharma or AdvaMed codes, which, while not legally binding, may influence industry standards.

6. Internal Policies: Highlighting the importance of company-set policies for day-to-day operations, which are more conservative than the law but serve as prudent forms of engagement.

7. Personal Risk Tolerance: Acknowledging that individual risk tolerance varies, and while policies guide the process, they won't eliminate personal risk tolerance.

The podcast emphasizes the need for companies to navigate these layers carefully and stay informed and compliant. It concludes with an invitation to seek assistance in creating digital health engagement programs by contacting the speaker via email at [email protected]

Website: http://www.darshantalks.com
Law Firm: http://www.kulkarnilawfirm.com
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LinkedIn: https://www.linkedin.com/in/darshanku...

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Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depen

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