I GLASS BANNER

Managing Field Force Compliance:
Keeping your Company and your Field-Based
 Teams in a 'Safe Harbor'
 

  
Meet us in Washington, D.C.
WLH Consulting, Inc. will be at the:

Fifteenth Annual Pharmaceutical Regulatory and Compliance Congress

November 3-5, 2014

Hyatt Regency on Capitol Hill
Washington, D.C.

Find us at Booth #10
pharma congress 

IN THE NEWS 


 

February, 2013

Mitigating Compliance Risks Across the Sales Execution Cycle

 

Rx for Compliance

September, 2013 

How to Create a Culture of Compliant Business Writing  


May, 2012 

Creating a Culture of Compliance with Lessons from NASA and the OIG

 

August, 2011 

 
February, 2011
 
Optimizing Sales Performance with Field Based Monitoring
 

 

 

Pharm Rep

March, 2011  

Inspect What You Expect: Field Based monitoring programs can help companies avoid problems before they start

Pharm Exec logo 

October, 2009 

The Changing Pharmaceutical Sales Landscape

Featured Offering

Learn more about
our I GLASS Field Based Monitoring Program™

 

This program proactively meets the requirements of recent CIAs for field force monitoring and is a comprehensive solution for training, coaching, monitoring, and reporting compliant field behaviors.

 IGLASS 

Since the infiltration of Corporate Integrity Agreements ("CIAs"), whistle-blowers, healthcare practitioners, consumers, and even competitors in pharmaceutical and biotech companies have been challenged with enforcing compliance. Not just for internal personnel - emails and healthcare expert speakers - but for the field-based teams - who are out on their own much of the time in front of their customers.
 

As we know, most companies have rolled out CIAs and guidelines with which to abide. Most have also beefed up their legal departments to include a Chief Compliance Officer to manage the challenges imposed on organizations due to the revolution of free-flowing information. This role requires someone who understands the complexities of the law and its ever-changing guidance, can garner support to instill a culture of compliance, and is an effective leader to the team - especially to the commercial team and those who are field-based. Competence in proactivity is critical - ability to constantly stay abreast of this dynamic is central to mitigating risk. "This is particularly important because having a proactive compliance program in place can help a company in terms of mitigation should a violation be identified. Regulatory agencies are more inclined to reduce penalties and other forms of punishment if a company is viewed as having been proactive in its compliance efforts," states Christopher Parrella of the Health Law Offices of Anthony C. Vitale, P.A.
 

The Legal team, the subsequent training, and its effective implementation are critical to maintaining a reliable 'Safe Harbor.' An impactful compliance team leader can proactively provide guidance and guardrails through various monitoring techniques and checkpoints to minimize potential risks. Field based monitoring should be implemented due to recent CIAs issued for sales and marketing misconduct by the U. S. government.   FBM has been established as a requirement in government imposed CIAs. Mary Riordan, Office of the Inspector General (OIG) and other government officials have stated that FBM is a minimum standard for effective compliance programs.
 

According to Dr. Wendy Heckelman, PhD, "Organizations who strive to maximize commercial value while mitigating compliance risk, are those who initiate a proactive approach. Field-based monitoring assesses commercial operations and behavior, thereby providing more direct benefits to the business. The use of this process allows a keen eye to be kept on desired skills and competencies such as customer focus and teamwork. By integrating FBM into the organization's Marketing and Sales functions, there is assurance that alignment on messaging and communications will be delivered to the field. Broadening the scope of traditional monitoring beyond areas of compliance enables the commercial organization to use FBM efforts to their advantage, thus providing greater benefit to the overall business."
 

"Concentrate on monitoring resources, however limited, on areas with the greatest risk, perform an analysis of all sales and marketing activities to prioritize what is most likely to cause consequences/repercussions for the company. Also, pay close attention and stay current on new trends in investigation and enforcement," recommends Dr. Heckelman.

 

By mitigating risk and providing guidance and guardrails for those in sales and marketing, a company's internal team establishes a 'Safe Harbor' - allowing business to grow and move forward while reducing the potential for warning letters and fines. According to an article by Geoff Garabedian, Quintiles Consulting on July 16, 2014, 'Regulators globally continue to increase their enforcement efforts. In the U.S., the FDA has made increases to the Health and Human Services budget request for 2015,[1] forecasting a boost in inspections from 2,678 to 2,855 [2].  The total number of warning letters issued rose from 1,720 in 2011, to 4,882 in 2012, and 6,760 in 2013.' 

 

 This growth in government activity will not abate.  It behooves organizations to build Field Based Monitoring into their behavioral observation practices, creating an environment that proactively manages compliance, aligning with the minimum standard of the OIG, while maintaining a 'Safe Harbor' for those impacted.

 

Dr. Wendy Heckelman, is the Founder and President of WLH Consulting, Inc. has worked with biopharmaceutical sales organizations on all stages of the compliance continuum.  Please feel free to contact Wendy to learn more about how to keep your company in 'safe harbor" and create a compliant field based organization. Please feel free to call 954-385-0770 or email to wendy@wlhconsulting.com.
 

WLH Consulting, Inc. has over twenty years of experience consulting in the biopharm industry. WLH combines this with our expertise in organizational and individual assessment, behavioral-based training, cultural change, and cross-functional alignment to provide recommendations and practical solutions to our compliance and commercial clients. 

 

 

 

[1] http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/
Reports/BudgetReports/UCM388309.pdf

 

 

 

[2] http://www.in-pharmatechnologist.com/Regulatory-Safety/
US-FDA-looks-to-increase-domestic-foreign-drug-manufacturer-inspections
  

 

 

 

Footer Line - grey