Commercialize products in a lawful fashion.
We help clients assess and mitigate regulatory risk.
Aggressive government enforcement continues. Whistleblower cases are on the rise due to economic incentives for qui tam plaintiffs. Off-label promotion, anti-kickback, and false claims prosecutions continue to be popular. Failure to comply can drive a manufacturer out of business and put employees in jail.
We assess commercial activities for compliance with the following laws:
Food, Drug and Cosmetic Act
False Claims Act
Physician Payments Sunshine Act
HIPAA & HITECH
Federal Trade Commission Act
Foreign Corrupt Practices Act
For more information about personal liability:
Paying HCPs, product discounting, providing reimbursement support and similar activities present legal exposure. Mitigate risk through an effective compliance program.
- Outsourced Compliance Function
- Designing and implementing compliance programs
- Monitoring and auditing
- Training management teams and staff on compliance laws and regulations
- Analyzing Sales and Marketing programs for compliance with FDA, CMS, OIG requirements
- Assisting companies subject to Corporate Integrity Agreements (CIA)
- Investigating allegations and hotline reports
- Reviewing discounting practices for Discount Safe Harbor compliance
- Analyzing transfers of value to HCPs for compliance with the Personal Services and Management Contracts Safe Harbor
- Reviewing reimbursement support services and program hubs
- Conducting compliance audits and compliance risk assessments of commercial activities
- Helping to mitigate, wind-down, and/or terminate risky practices
- Performing healthcare and FDA regulatory due diligence for buyers and sellers
- Reviewing research activities, e.g., advertising and recruitment practices
- Training on best documentation practices
- Reviewing contracts
- Reviewing privacy policies
- Auditing against the PhRMA and AdvaMed Codes