Compliance Counseling - FDA
The PhRMA Code of Conduct and OIG Guidance, as well as recent government Settlement Agreements, have placed increased emphasis on proactive compliance activities. Our FDA group has worked with manufacturers to design and implement comprehensive compliance programs in order to avoid improper activities and enforcement action.
We have drafted FDA, healthcare and privacy compliance documents including Codes of Conduct and Policies and Procedures, as well as more handy Field Guides for sales personnel on the move. Key risk areas of focus are:
- Educational grants
- Advisory boards and consultant meetings
- Charitable donations
- Promotional activity
- Research and clinical trials
- Business meals and gifts
- Continuing Medical Education
- Displays and exhibits
- Investigator-initiated grants
- Promotional speaker programs
- Publication activities
- Medical science liaisons
- Related State laws
We work with companies worldwide to develop comprehensive FDA, healthcare and privacy compliance training programs, including:
- Mandatory basic and specific training as required by Corporate Integrity Agreements (CIAs)
- Hands-on training for sales and marketing personnel
- Training modules intended to reinforce specific training objectives
We also assist in-house counsel and compliance officers in responding to compliance issues from internal clients, such as grant committees, sales and marketing personnel, regulatory affairs, medical education/medical affairs and clinical affairs. In particular, we assist with issues related to:
- Reviewing and approval of educational and research grants
- Structuring advisory boards
- Retaining consultants
- Reviewing and approval of advertising and promotional practices
We also handle numerous sensitive internal investigations of compliance matters, including issues raised in confidential hotline phone calls, and provide independent review and analysis of alleged violations.
