What are the penalties for non-compliance with ACA 6002 and ACA 6004?
Non-compliance with ACA 6002 (Sample Transparency) or ACA 6004 (Spend Transparency) can result in significant penalties for pharmaceutical companies, including:
Fines of up to $10,000 per payment or transfer of value not reported (for ACA 6002)
Fines of up to $100,000 per payment or transfer of value not reported due to “knowing failure” (for ACA 6002)
Fines of up to $1,000 per day, per violation for failure to report drug sample information (for ACA 6004)
Damage to the company’s reputation and loss of trust from customers and partners
Increased scrutiny and audits from regulatory authorities