Regulatory Compliance, Investigations & Disputes
The life sciences industry is growing ever more complex, with expanded government enforcement accompanied by new and increasingly demanding regulatory requirements. FTI Consulting is well-positioned to assist pharmaceutical manufacturers, biotech and medical device companies in meeting these growing challenges.
In today’s regulatory climate, life sciences companies need targeted compliance programs to prevent and detect violations and to respond effectively when issues arise. FTI Consulting has the expertise to evaluate the effectiveness of compliance and ethics programs and to develop a proactive approach to mitigating risks.
Among other things, we assist our clients in developing and implementing auditing and monitoring regimens designed to identify potential risk areas. We have performed this work on a proactive basis and also as an Independent Review Organization under dozens of corporate integrity agreements.
FTI Consulting has played a significant role in many of the best-known and most substantial healthcare investigation and litigation matters. These experiences enable us to play an invaluable role in strengthening client operations and protecting assets and reputations. We provide proven and cost-effective solutions based on benchmarking, advanced statistical sampling, development of complex industry and company-specific databases, and sophisticated risk assessment techniques.
Our services and experience include:
- Investigations into improper promotion, including off-label marketing
- Anti-kickback statute investigations
- Investigations into Medicaid Drug Rebate Program, Medicare Part B Drug Average Sales Price, 340B Drug Program and Veterans Administration/Department of Defense Price Reporting issues
FTI Consulting frequently is called to assist in complex litigation matters, including False Claims Act cases, business disputes and other issues. We have testified as expert witnesses at trial and deposition in federal and state proceedings, before administrative bodies, and in bankruptcy and tax court. Our nationwide team includes seasoned healthcare professionals with expert credentials in accounting, finance, economics, valuation, computer forensics and fraud investigations.