Off-Label Investigations DOWNLOAD

You may only get one chance to do it right — does your organization have the proper tools and resources in place to execute an effective response to off-label promotion allegations and mitigate the risk of future allegations?

Your issue

Many pharmaceutical and specialty biotechnology organizations have taken proactive steps to detecting and mitigating the risk of off-label promotion of its products. However, whistle-blower allegations; issues discovered during routine audits; customer complaints; Corporate Integrity Agreement requirements; management/sales- force misconduct, and; regulatory inquiries; can occur and lead to an investigation into improper promotional activity. In recent years there has been a rise in these types of government led investigations as regulators scrutinize a company's efforts to promote its products and mitigate the risks associated with of off-label promotion. There is no one-size fits all approach to managing this difficult situation.

Conducting an independent internal investigation that can withstand internal and external scrutiny often requires experience, judgment, an understanding of issues and industry, and the right people and technological tools.

What are the leading practices?

Recognizing and understanding the provisions of Corporate Integrity Agreements (CIAs) that industry participants enter into with the Office of the Inspector General (OIG) of the Department of Health and Human Services provide insight into leading Off-Label deterrence, detection and remediation practices.

One recent example involved a major drug manufacturer's CIA entered into as the result of off-label marketing activities of a popular mental health drug. The provisions of this CIA require the company to implement systems, policies, processes and procedures relating to the approval of marketing materials, sales force training, sampling, and responding to requests about off-label indications, field force monitoring and similar types of activities.

For those organization not yet subject to investigations, the best defense is a good offense: off-label marketing response management plan. Such a plan allows for a system for prompt, competent, and confidential investigation of allegations involving potential off-label marketing misconduct. Accordingly, components of an effective off-label marketing response management plan may include:

• Benchmarking whistleblower hotline activity to assess effectiveness
• Establishing investigative protocols to include interviewing, evidence collection, computer examinations, and analysis
• Identifying both internal and external resources, in advance of a crisis
• Utilizing a case management system to efficiently track and log the resolution of off-label marketing allegations
• Implementing process and control improvements enterprise-wide to gain efficiencies and prevent recurrences

"Many will agree having protocols and analytics in place is critical to managing off-label marketing issues. However, companies face increased risk when those protocols and metrics are not understood, adopted, or leveraged in the face of a pending action." 

- Yogesh Bahl, Partner, Deloitte FAS

Our solution

Deloitte's Life Sciences investigations professionals bring the industry experience, financial acumen, investigatory skills and technological tool kit together to help multinational pharmaceutical and specialty biotechnology companies respond to allegations of off-label promotion. Our clients draw on our skills, both to conduct objective investigations and to work with counsel in defending companies and individuals. We collaborate with our client's management team to develop a phased investigative approach to quickly ascertain foundational facts and identify critical issues, while maximizing overall project efficiency and cost-effectiveness. During the course of an investigation, we often work with clients to:

• Assess the issues in the context of the business environment in which the company operates
• Preserve electronic evidence from various information systems that can later hosted and searched using forensic technology
• Conduct regular informational briefings with company employees with specific knowledge of the transactions
• Analyze and understand the system of internal controls to assess whether they fostered or mitigated the alleged behavior
• Conduct econometric analyses to establish or challenge causation assumptions about the alleged market impact of promotional activity
• Assist counsel with presentation of findings to regulators or provide testimony during official proceedings

Our investigation teams provide actionable recommendations that position our clients to institute organizationally relevant remedial actions. This includes empowering ongoing compliance monitoring for which we have introduced technological solutions that provide:

• A Sales Representative selection model
• Anomaly & Trend Detection
• Correlation & Summary Statistics

The Deloitte FAS difference

Life science industry knowledge

Deloitte FAS has a dedicated team of full-time life sciences industry practitioners who serve multinational pharmaceutical, biotech and medical device companies, government agencies, and thousands of fast growing life science business both public and private. Our practitioners have sound knowledge of the different regulatory agencies typically involved in government initiated investigations — e.g. DOJ, HHS OIG, CMS and various state agencies. Our consultants bring deep experience in as life science forensic investigators, former regulators, clinicians, forensic accountants, statisticians and former industry executives to evaluate and monitor an organizations risk of off-label promotion activity.

Investigations experiences and perspective

Deloitte FAS professionals are experienced at identifying, organizing, and managing both physical and electronic evidence, under the direction of counsel, for subpoena responses and to help analyze the relevant evidence and find the facts upon which the successful outcome of a client matter may rely. We have the mindset to focus analyses on the exceptions, the oddities, irregularities, and specific patterns of conduct avoiding the "everything but the kitchen sink" approach. Depending on the circumstances, we serve as consultants to counsel representing the company, a special committee of the board of directors, or senior management in addressing formal or informal regulatory inquiries.

Drive value

Through our collaborative approach, Deloitte FAS aims to maximize the benefit from investigations while employing the right mix of resources and accelerators to minimize cost. We employ off-shore resources and local teams when possible to increase the speed of analysis and review and decrease the cost of the project. Our understanding of off-label promotion paired with the tools for early case assessment allows us to tailor and implement workflows that capture information that is pertinent to the investigation. When investigations do require data acquisition, analysis, hosting, review, and production, we provide the complete eDiscovery continuum, eliminating multiple vendors and redundant costs. Combined we feel our approach results in strategically driven, but tactically executed investigations.

This publication contains general information only and Deloitte Financial Advisory Services LLP, Deloitte LLP and related entities are not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor. Deloitte Financial Advisory Services LLP, Deloitte LLP and related entities shall not be responsible for any loss sustained by any person who relies on this publication. 

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