Regulatory Compliance, Investigations, and Disputes
The life sciences industry is one of the largest and fastest growing segments of the global economy. It is also one of the most competitive and heavily regulated. The operational and regulatory demands on the industry are already substantial, and they are growing as competitive pressures increase and governments impose tighter regulations in an attempt to balance access to life sustaining and enhancing treatments with economic constraints.
For many years industry regulatory enforcement was focused on: (i) improper remuneration to healthcare professionals (HCPs) and institutions; (ii) unapproved marketing of drugs and devices; and (iii) improper pricing of products to governmental payers. In recent years the U.S. government has also focused on the use of the Foreign Corrupt Practices Act to police activities of life sciences companies outside the U.S. Other governments have also tightened laws and enforcement, with a particular focus on anti-bribery and anti-corruption efforts that target payments and other economic incentives provided to healthcare providers and government officials. These governmental initiatives have been matched by a corresponding growth in U.S. federal and state-level whistleblower cases, which have resulted in a steady stream of expensive litigation and resulting settlement costs.
In short, regulatory compliance risks for the life science industry have continued to increase dramatically. To control these risks, these entities and their legal counsel need access to sophisticated and high-powered resources, with a global reach, to assess compliance related risks, develop and implement state-of-the-art compliance tools and resources, perform compliance investigations, and remediate compliance-related gaps and deficiencies.
How Do We Do It?
FTI Consulting’s Regulatory Compliance, Investigations, and Disputes (RCID) team uses an integrated approach to best address the unique needs of each of our clients. We emphasize cross-collaboration amongst our multi-disciplinary group of industry-experienced compliance and investigative professionals, to bring the right mix of experience and skills to bear on each assignment. This approach enables FTI to use our resources efficiently to best meet the needs of each client and assignment, while remaining nimble, responsive, and creative. Our approach combines the skills of industry specialists with those of compliance and strategic communications experts, investigative professionals, forensic accountants, computer forensic specialists, and electronic evidence and technology consultants. These are supplemented, as necessary, with experts in healthcare provider and payer matters.
FTI’s distinctive approach enables us to help our clients confront issues intelligently and efficiently, whether we are assessing the effectiveness of compliance programs, helping to develop and implement strategic solutions to challenging problems, conducting investigations, responding to information requests and subpoenas, supporting litigation-related activities, or supporting decision-making by management and boards. Our investigations and litigation support work is based on proven, efficient, and cost-effective approaches that emphasize benchmarking, advanced statistical sampling approaches, development of complex databases, and solid risk assessment techniques.