John Patrick Oroho

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John Patrick Oroho is a principal of Porzio, Bromberg & Newman in the Life Sciences Compliance and Regulatory Counseling Department. His practice is concentrated in the areas of regulatory compliance with respect to Aggregate Spend, Physician Payment Sunshine Act, the Prescription Drug Marketing Act (“PDMA”), Antikickback Statute, False Claims Act, and Medicare and Medicaid fraud and abuse. Mr. Oroho is a noted expert on pharmaceutical compliance, specifically OIG and state compliance with Sales and Marketing and product distribution. He has written and lectured extensively on these, as well as other life science compliance issues. He has worked with companies under Corporate Integrity Agreements to ensure their compliance with the standards established for pharmaceutical marketing and sales. Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance. Mr. Oroho has been responsible for the development of Aggregate Spend systems and PDMA-compliant sample tracking systems.

Mr. Oroho is also Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC, a wholly owned subsidiary of the law firm. He meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their understanding of acceptable practices and conduct in meeting compliance requirements of all 50 states and the District of Columbia.

Prior Relevant Experience
  • Integrated Pharma Technologies, General Counsel & Director of Operations, 2002–2003
  • Computer Systems Services & Consulting, General Counsel and Director of Business Development, 2000–2002
  • Struble Ragno Petrie Oroho Spinato Bonanno MacMahon & Conte, P.C., Senior Partner, 1989–2000
  • Bruinooge & Associates, Associate, 1987–1989
  • Riker, Danzig, Scherer, Hyland & Perretti, Associate, 1987
  • Fulbright & Jaworski, Associate, 1985–1987
Honors and Awards
  • Recognized in Who's Who Legal – Compendium Edition, 2017
  • Recognized in Who's Who Legal: Life Sciences - Regulatory, 2016
  • Recognized in Who's Who Legal: Life Sciences, 2015
  • "European Healthcare Compliance Certification," Seton Hall European Healthcare Compliance Program, Paris, France, November 12 to November 16, 2012

Honors and Awards

Organizations/Memberships
  • American Bar Association
  • New Jersey State Bar Association
  • PDMA Alliance
  • Family Resource Network, Board of Trustees
  • Catholic Academy of Sussex County, Board of Trustees
  • Federal Academy Selection Committee for Congressman Scott Garrett (R-NJ)
  • University of Notre Dame Law Association
  • United States Merchant Marine Academy Alumni Association
Publications
  • Co-Author, "Getting the Deal Through - Life Sciences 2014," United States Chapter, published by Getting the Deal Through, 2014.
  • Co-Author, "Getting the Deal Through - Life Sciences 2013," United States Chapter, published by Getting the Deal Through, 2013.
  • Co-Author, "The Who, What, When and Why of the Sunshine Act,” PM360 Magazine, June 1, 2013.
  • Co-Author, "Getting the Deal Through - Life Sciences 2012," United States Chapter, published by Getting the Deal Through, February 2012.
  • "Update on Aggregate Spend Reporting in the U.S. – Impacts for Europe," CBI’s Global Transparency Reporting Congress, Implement Compliant Global Systems to Track Quality Data, London, UK, February 28, 2012.
  • Editor, "The New Reality of Sales Force Behavior and Management," FDLI Monograph Series, Vol. 2, Num 6, June 2011.
  • Co-Author, "What's All the Commotion Over Aggregate Spend?," Thought Leadership Sales and Marketing Compliance, Fall 2009.
  • Co-Author, "Sales Rep Nightmares: Emerging Issues in Marketing Compliance," FDLI Update, May/June 2009.
  • Interviewed as subject expert, "Explosion of State-Level Gift Bans and Regulatory Inconsistencies Threaten Marketing Research," RFL Pharma Market Research, October/November 2008.
  • Co-Author, "'Voluntary' Guidance: How States Are Mandating Compliance with Federal and Industry Guidance," FDLI Update, July/August 2008.
  • Co-Author, "Waiting for the Other Shoe to Drop: Complying with California’s Pedigree Law," Thought Leadership Sales and Marketing Compliance, Volume 2, Issue 8, Summer 2008.
  • Co-Author, "Newly Enacted Nevada Statute Requires Adoption of a Marketing Code of Conduct," Porzio Pharmaceutical Alert, Volume III, No. 3, June 18, 2007.
  • Quoted in, "Online DTC: Marketing Push Meets Consumer Pull," Pharmaceutical Commerce, May 30, 2007.
  • Co-Author, "Marketing Cost Disclosures and Prohibitions – The New Frontier," Thought Leadership Sales and Marketing Compliance, Volume 2, Issue 6, Spring 2007.
  • Co-Author, "Can Prosecutors Use Data from Sample Distribution as Evidence of Off-Label Promotion?" Thought Leadership Sales and Marketing Compliance, Volume 2, Issue 6, Spring 2007.
  • Expert Discussion, "The Complexity of Compliance," Future Pharmaceuticals, Q4 Edition 2, 2006.
  • Co-Author, "Louisiana Revisits Drug Samples and Lobbying: An Overview of Recently Enacted Laws," Porzio Pharmaceutical Alert, Volume II, No. 7, July 20, 2006.
  • Quoted in "State Bill Would Criminalize Gift-Giving," Medical Marketing & Media, Vol. 41, No. 7, July 2006.
  • Quoted in "Team Effort: Collaboration is Replacing Competitive Edge When It Comes to Sales Compliance Training," Pharmaceutical Regulatory Guidance Book, July 2006.
  • Co-Author, "FDA Lifts Stay on PDMA Pedigree Provisions: Is Your Company Prepared?," Porzio Pharmaceutical Alert, Volume II, No. 6, June 26, 2006.
  • Quoted in "Massachusetts May Become First State to License Drug Reps: Pending Measure Would Make Gifts to Physicians a Crime, Warn Attorneys," Rx Compliance Report, Vol. V, Issue 7, June 21, 2006.
  • Co-Author, "Maine Department of Health and Human Services Issues Proposed Rules to Govern the Disclosure of Clinical Trials and Pharmaceutical Marketing Expenses," Porzio Pharmaceutical Alert, Volume II, No. 5, May 9, 2006.
  • Co-Author, "The Rise of Coupons and Vouchers," Thought Leadership Sales and Marketing Compliance, Volume 1, Issue 3, Spring 2006.
  • Co-Author, "A Call for Consistency," Thought Leadership Sales and Marketing Compliance, Volume 1, Issue 3, Spring 2006.
  • Co-Author, "Louisiana Weighs in on Drug Samples and Lobbying: An Overview of Recent Opinions by Louisiana’s Board of Ethics," Rx Compliance Report, Volume V, Issue 3, March 21, 2006.
  • Co-Author, "Louisiana Weighs in on Drug Samples and Lobbying: An Overview of Recent Opinions by Louisiana’s Board of Ethics," Porzio Pharmaceutical Alert, Volume II, No. 2, February 15, 2006.
  • Co-Author, "A Dose of Preventive Medicine: Establishing Proactive Sample Accountability," Thought Leadership Sales and Marketing Compliance, Volume 1, Issue 2, Winter 2006.
  • "'Lights, Camera, Cut' State Actions on Direct-to-Consumer Advertising,” Thought Leadership Sales and Marketing Compliance, Volume 1, Issue 1, Autumn 2005.
  • "The New Sheriff in Town: States’ Encroachment on Pharma Marketing," Thought Leadership Sales and Marketing Compliance, Volume 1, Issue 1, Autumn 2005.
  • "Today’s Pharmaceutical Criminal Investigation is Tomorrow’s Product Liability Lawsuit," LJN’s Product Liability Law & Strategy, October 2004.
  • "Mandatory Disclosure of Gifts to Physicians," Commerce Magazine, April 2004.
Speaking Engagements
  • "Navigating State, Federal, and International Transparency Disclosure Requirements," Healthcare Compliance Certification Program, Seton Hall Law, Center for Health & Pharmaceutical Law & Policy, Newark, NJ, June 14, 2017.
  • "Preparing for the Possibility of an Open Payments Audit – Your Data…The Government is Watching," The 8th Annual West Coast Forum on Transparency & Aggregate Spend, Leverage Data Analytics to Create Business Value, San Diego, CA, May 23, 2017.
  • "Aggregate Spend – 20 Things to Know About Transparency," 13th Annual Medical Device Compliance Congress, San Diego, CA, May 22, 2017.
  • "Summit Host Welcome and Anti-Trust Guideline Reminders," CBI's 14th Annual Pharmaceutical Compliance Congress, Washington, DC, April 27, 2017.
  • "Staying Ahead of Current and Emerging Regulations Impacting Sample Reporting and Compliance," CBI's Next Generation Pharmaceutical Samples, Philadelphia, PA, April 12, 2017.  
  • Panelist, "The State of the Life Science Industry," The Morris County Economic Development Corporation, 25th Annual Awards Luncheon, Whippany, New Jersey, March 10, 2017.
  • “Understanding Disclosure Laws from All Corners," Synergistix User’s Conference 2017, Fort Lauderdale, FL, March 9, 2017.
  • "Welcome," "Closing Remarks and Program Conclusion," Porzio Compliance Forum, Newark, NJ, February 10, 2017.
  • "The Intersection of Global Meetings and Global Transparency," CBI's 5th Annual Global Pharmaceutical and Medical Meetings Summit, Philadelphia, PA, February 1, 2017.
  • Anti-Trust Attorney, CBI's 3rd Annual Global Compliance Congress, London, UK, November 16, 2016.
  • Anti-Trust Attorney, CBI's 7th Annual West Coast Compliance Congress, San Francisco, CA, November 9, 2016.
  • "Understanding Federal and State Reporting Laws from All Corners," U.S. Healthcare Compliance Certification Program, Seton Hall Law School, Newark, NJ, October 26, 2016.
  • "HCP Interaction Risk Management," Moderator, 17th Annual Pharmaceutical Compliance Congress Best Practices Forum, Washington, DC, October 20, 2016.
  • "Structuring and Initiating Your Global Transparency Compliance Program," Moderator, CBI's 10th Annual Forum on Transparency and Aggregate Spend, Washington, DC, August 16, 2016.
  • "Understanding Federal and State Reporting Laws from All Corners," Seton Hall Healthcare Compliance Certification Program, Newark, NJ, June 15, 2016.    
  • "Aggregate Spend Trends," Sales Operations Leadership Council Meeting, MedPro, Mt. Arlington, NJ, June 2, 2016.  
  • "Tips for Moving From Domestic to International Reporting and EFPIA-U.S. Reporting Requirements," CBI's 7th Annual West Coast Forum on Transparency and Aggregate Spend, San Diego, CA, May 18, 2016.
  • "Mini Summit XV: Advanced Issues in Applying Analytics - Using the Data to Provide Value and Partner with the Business," Panelist, The 10th International Pharmaceutical Congress and Best Practices Forum, Warsaw, Poland, May 11, 2016.
  • Track Chair, "Data Analysis, Risk Mitigation and Predictive Analytics," CBI's 13th Annual Pharmaceutical Compliance Congress, Washington, DC, April 27, 2016.
  • Summit Host, Chief Compliance Officer Summit, CBI's 13th Annual Pharmaceutical Compliance Congress, Washington, DC, April 26, 2016.
  • Moderator, "Informing HCPs Prior to Disclosure and Planning for Error Remediation," 6th Annual Global Transparency Reporting Congress, Frankfurt, Germany, April 7, 2016.
  • "State Laws that Could Delay Product Launch or Distribution," Seton Hall Law's West Coast Life Sciences Compliance Training Program, San Francisco, CA, March 22, 2016.
  • "Transparency - Present and Future," Synergistix 12th Annual Users Conference, Pompano Beach, FL, March 3, 2016.
  • "Data Analytics – How to Use Them to Predict Future Behavior," Moderator, Porzio Compliance Forum, Newark, NJ, December 3, 2015.
  • "Optimize Compliance Program Structure through Enhanced and Informed Resource Allocation," Moderator, CBI West Coast Compliance Congress, San Francisco, CA, November 5, 2015.
  • "Mini Summit VII: Predictive Analytics," 16th Pharmaceutical Compliance Congress and Best Practices Forum, Washington, DC, October 22, 2015.
  • "Understanding Federal and State Disclosure Laws From All Corners," Seton Hall Healthcare Compliance Certification Program, Seton Hall Law, Center for Health and Pharmaceutical Law & Policy, Newark, NJ, October 12, 2015.
  • "Open Payments/Sunshine Act:  Don't Get Burned By What You Don't Know," 2015 PDMA Sharing Conference, Baltimore, MD, September 27, 2015.   
  • "Strategies to Reduce Compliance Risks and Optimize Commercial Programs Using Transparency Data Analytics," Panelist, CBI's 9th Annual Forum on Transparency and Aggregate Spend, Washington, DC, August 18, 2015.
  • "Lessons Learned From the First Two Years of Sunshine Reporting," Pharmaceutical and Life Sciences Accounting Conference, Iselin, NJ, June 11, 2015.
  • "Understanding Federal and State Reporting Laws from All Corners," U.S. Healthcare Compliance Certification Program, Seton Hall University School of Law, Newark, NJ, June 10, 2015.
  • Panel Moderator, "Leveraging Open Payments Data to Minimize Risks and Maximize Growth," CBI's 6th Annual Transparency Reporting West, San Diego, CA, April 21, 2015.
  • Panel Moderator, "Interpreting Lessons Learned from U.S. Open Payments Reporting (Sunshine Law) into Actionable Strategies for Managing HCP Relationships and Consent Agreements,"  CBI's 5th Annual Global Transparency  Reporting Congress, London, UK, April 15, 2015.
  • "Lessons Learned from the First Two Years of Sunshine Reporting," 2015 Synergistix Users Conference, Deerfield Beach, FL, March 12, 2015.
  • "Open Payments Compliance and Dispute Resolution," Track Chair, CBI's 12th Annual Pharmaceutical Compliance Congress, Washington, DC, March 4, 2015.
  • "Welcome and Antitrust Guidelines Reminders," Chief Compliance Officer Summit Host, CBI's 12th Annual Pharmaceutical Compliance Congress, Washington, DC, March 3, 2015.
  • "Deep Dive on State Regulatory Changes for Sample Reporting," CBI's Sample Compliance and Reporting Summit, Philadelphia, PA, February 25, 2015. 
  • "Ask the Experts Panel – "Strategies to Optimize Sample Compliance," Moderator, CBI's Sample Compliance and Reporting Summit, Philadelphia, PA, February 25, 2015.
  • "Determine What Impact Public Disclosure has on Establishing FMV," HCP Engagement, Data Validation & Reporting, Philadelphia, PA, November 18, 2014.
  • "Working in Conjunction with the Business – Ensure Compliance Adds Value to Operational Success," Compliance Officer Panel, CBI's West Coast Compliance Congress, San Francisco, CA, November 13, 2014. 
  • Co-Moderating, "Industry Consultant/Legal Counsel Compliance Best Practices Think Tank," 15th Annual Pharmaceutical Compliance Congress and Best Practices Forum, Washington, DC, November 5, 2014.
  • "Transparency Update: Status of Sunshine Act Compliance," 15th Annual Pharmaceutical Compliance Congress and Best Practices Forum, Washington, DC, November 4, 2015."Introduction on Advanced Issues in Domestic and Global Transparency," 15th Annual Pharmaceutical Compliance Congress and Best Practices Forum, Washington, DC, November 3, 2014.
  • Moderator, "Keynote Panel: Global Transparency of HCP Data - The Current Environment and Future Direction of Disclosure Code," CBI International Pharmaceutical Compliance Congress, Brussels, Belgium, October 22, 2014.
  • "Understanding Federal and State Reporting Laws from All Corners," Healthcare Compliance Certification Program, Seton Hall Law, Center for Health and Pharmaceutical Law and Policy, Newark, NJ, October 15, 2014.
  • "Licensing and Distribution:  Possible Delays to Product Launch," Seton Hall Life Science Compliance Program West Coast Immersion, San Francisco, CA, September 9, 2014. 
  • "Legal/Industry Update on Impact of Sunshine and Preparing for Public Disclosure," Co-Moderator, CBI's 8th Annual Forum on Transparency & Aggregate Spend, Washington, DC, August 19, 2014.
  • "Crisis Management/Recalls-Effects of Counterfeit Drugs and Healthcare Risks to Consumers," Moderator, National Society of Hispanic MBA's Healthcare Summit, Montclair State University, Montclair, NJ, June 13, 2014.
  • "Understanding Federal and State Disclosure Laws From All Corners," Healthcare Compliance  Certification Program, Seton Hall Law, Center for Health and Pharmaceutical Law and Policy, Newark, NJ, June 9, 2014.          
  • "Update on Guidance Changes," Panelist, Ask the Experts Panel, CBI's 5th Annual West Coast Forum on Transparency & Aggregate Spend, San Diego, CA, April 25, 2014.
  • "Through the Looking Glass – The Future of Aggregate Spend Reporting," Moderator, Eye Opener Keynote Panel, CBI's 5th Annual West Coast Forum on Transparency & Aggregate Spend, San Diego, CA, April 24, 2014.
  • "Excellence in Compliance (Sunshine Act Milestones)," Synergistix 10th Annual Users Conference, Deerfield Beach, FL, March 6, 2014.
  • "Trends in Aggregate Spend," Sales Operations Leadership Council, Bridgewater, NJ, February 20, 2014.
  • Panelist, "Technology Solutions: Insights on Current and Future Trends in Aggregate Spend Technology," Arlington, VA, February 5, 2014.
  • Chief Compliance Officer Roundtable: "How Disclosure/Transparency Compliance Fits into a Successful Global Compliance Program," The Sixth Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies, Arlington, VA, February 5, 2014.
  • "Healthcare Regulations and Their Impact on Your Meetings," The Second Annual Global Pharmaceutical and Medical Meetings Summit, Philadelphia, PA, February 4, 2014.
  • "Compliance Skills – Role of a Compliance Officer," Speaker, Seton Hall Law School, Newark, NJ, January 16, 2014.
  • "Compliance Considerations Related to Distribution and Licensing Models," CBI’s 4th West Coast Compliance Congress, San Francisco, CA, November 13, 2013.
  • Panelist, Ask the Experts Panel, "Sunshine and Transparency Initiatives in Preparation for the 2014 Milestones," CBI’s 4th West Coast Compliance Congress, San Francisco, CA, November 13, 2013.
  • "Mini Summit XXII: Developing Appropriate Target Lists for Sampling, Detailing and Speaker Meeting Invitees," Moderator, 14th Annual Pharmaceutical Regulatory and Compliance Congress, Washington, DC, October 29, 2013.
  • Moderator on Panel, "In-House Chief Compliance Officers and General Counsel Panel Discussion," Porzio Compliance Forum, "Small and Mid-Sized Life Sciences Companies Still Face Big Issues – Minimizing the Risks," Newark, NJ, October 18, 2013.
  • "Understanding Federal and State Reporting Laws from All Corners," Healthcare Compliance Certification Program, Seton Hall, October 14, 2013, Newark, NJ.
  • "An Intermediate Level Course for Fine-Tuning Policies and Procedures," CBI’s 7th Annual Forum on Sunshine and Aggregate Spend, August 19, 2013, Washington, DC.
  • "Mini-Summit VII: Compliance Issues for Small-Mid Size Pharma and Biotech Companies – Welcome and Overview," The International Pharmaceutical Compliance Congress and Best Practices Forum, Madrid, Spain, May 22, 2013.
  • "Ask the Experts – The Sunshine Act Today and Tomorrow," Concur Fusion 2013 Conference, Las Vegas, NV, April 16, 2013.
  • "Sunshine Updated: Explore Regulations and Experience in France and the U.S.," CBI’s 3rd Global Transparency Reporting Congress, Brussels, April 10, 2013.
  • "Drug Samples Disclosure," Moderator, Fifth Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies, Washington, DC, February 20, 2013.
  • "Updates to the State and Federal Laws," Synergistix User's Conference 2013, Fort Lauderdale, FL, February 12, 2013.
  • "Sunshine Readiness for Reporting," Track Chair, CBI’s Pharmaceuticals Compliance Congress, Washington, DC, January 29, 2013.
  • "Unraveling the Final Sunshine Regulations to ensure Readiness for 2013," Panel Moderator, CBI's 3rd Annual West Coast Compliance Congress, San Francisco, CA, November 29, 2012
  • Panel Chair, "Mini Summit XVI: Drug Samples Disclosure: The Next Horizon?" Thirteenth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, Washington, DC, November 6, 2012.
  • "Unpacking the FDA Federal Prescription Drug Sample Transparency Regulations,"CBI’s 6th Annual Forum on Sunshine and Aggregate Spend, Washington, DC, August 15, 2012.
  • "Global Transparency – Lessons Learned from U.S. Reporting," Porzio Pharmaceutical Services, LLC Webinar, May 30, 2012.
  • "Update on Aggregate Spend Reporting in the U.S. – Impacts for Europe and Global Transparency," The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum, Budapest, Hungary, May 15, 2012.
  • "Ask the Experts," Sunshine Act Panel, Concur Users Conference, Orlando, FL, May 8, 2012.
  • "Best Practices for Effectively Maintaining an Aggregate Spend Program," CBI’s 3rd Annual West Coast Forum on Sunshine, State Laws and Aggregate Spend, San Diego, CA, April 16, 2012.
  • Moderator on Panel, "Drug Samples: The Next Horizon?" 4th Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies, Washington, DC, March 27, 2012.
  • "Federal Sunshine Act and Other Disclosure Requirements," Otsuka America Pharmaceutical, Inc. Sunshine Act Presentation and Discussion, Lambertville, NJ, March 20, 2012
  • Session Chairperson, "Meeting the Federal and State Requirements for Appropriate Marketing Practices: Update," Marketing Pharmaceuticals 2012: Workshop for Regulatory / Legal / Communications Professionals and Promotional Review Teams, Washington, DC, February 16, 2012.
  • "Update on State Disclosure and Sampling," CBI’s 9th Annual Pharmaceutical Compliance Congress, Washington, DC, January 25, 2012.
  • "Update on Physician Payments Sunshine and Sample Transparency Regulatory Requirements," CBI’s 2nd Annual Life Sciences West Coast Compliance Congress, San Francisco, CA, November 14, 2011.
  • "Meeting New Transparency Requirements: Implementing a Scalable Aggregate Spend System," FX Conferences, Morristown, NJ, October 18, 2011.
  • "The Government Made Me Do It: CIAs/DPAs/NPAs," The Life Sciences Industry Under Attack—Mitigating the Risks, Seventh Annual Porzio Compliance Forum, Newark, NJ, October 14, 2011.
  • Panelist, "Regulatory Update - How are Current Promotional Guidelines Impacting Product Marketing Approvals," 6th Annual PharmaForce Event, Princeton, NJ, October 4, 2011.
  • "State Laws, Sunshine and Aggregate Spend Boot Camp – Practical Strategies and Best Practices for Compliant State and Federal Reporting Workshop," CBI’s 5th Annual Forum on Tracking State Laws and Aggregate Spend, Arlington, VA, August 15, 2011.
  • Moderator, "Implement a Scalable Aggregate Spend Solution," CBI’s 7th Annual Medical Device and Diagnostics Compliance Congress, Falls Church, VA, June 8, 2011.
  • "State and Local Regulatory Reports Beyond Sunshine Requirements," CBI’s 2nd Annual West Coast Forum on Tracking State Laws and Aggregate Spend, San Diego, CA, April 13, 2011.
  • "Industry Update: Federal and State Aggregate Spend Requirements," FX Audio Conference, April 6, 2011.
  • "Aggregate Spend Technology Solution Provider Roundtable," Third Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies, Washington, DC, March 11, 2011.
  • "Updates on the State Laws and an Update on the Sunshine Payment Act," Synergistix Users Conference, Fort Lauderdale, FL, March 2, 2011.
  • "Meeting the Federal and State Requirements for Appropriate Marketing Practices," DIA Meeting, Marketing Pharmaceuticals 2011: Workshop for Regulatory Professionals and Promotional Review Teams, Washington, DC, February 22, 2011.
  • "Update on Sunshine and State of the States – Disclosure, Sample and Lobbying Laws,” CBI’s 8th Annual Pharmaceutical Compliance Congress, Washington, DC, January 25, 2011.
  • "Blend Data and Regulatory Components with Your Aggregate Spend Approach - Ensure Flexibility and Demand Compliance," CBI's West Coast Life Sciences Compliance Congress, San Diego, CA, November 19, 2010.
  • "Examine Requirements within the Federal Sunshine Act and State Disclosure Law,"CBI's West Coast Life Sciences Compliance Congress, San Diego, CA, November 18, 2010.
  • Panelist, 6th Multi-Channel Sampling Strategies Conference, Philadelphia, PA, October 25, 2010.
  • "Basics of Sunshine Provision and State Laws," Seton Hall Law School and Porzio Pharmaceutical Services Aggregate Spend Forum: Solving the Aggregate Spend Puzzle, Newark, NJ, October 15, 2010.
  • "Samples Disclosure State and Federal," Pharmaceutical Compliance Congress, Philadelphia, PA, September, 22, 2010.
  • "Update on State Laws and Expectations with the Physician Payments Sunshine Provision," Sales Operations Leadership Council Meeting, Princeton, NJ, September 21, 2010.
  • "Update on Recent and Proposed State Transparency and Disclosure Laws," CBI's 4thAnnual Forum on Tracking State Laws and Aggregate Spend, Washington, DC, August 17, 2010.
  • "Physician Payment Compliance," PPS Webinar Presentation for FDAnews, June 17, 2010.
  • "Update on State Laws and Expected Requirements within the Proposed Physicians Payment Sunshine Act," CBI's 6th Annual Pharmaceutical Compliance Congress, Boston, MA, June 8, 2010.
  • "State Transparency Initiatives - Insight from the Trenches,” Panel Moderator, CBI's Inaugural West Coast Forum on Tracking State Laws and Aggregate Spend, San Diego, CA, April 21, 2010.
  • "Compliance Meeting Packages - An Introduction to the Regulatory Framework for Medical Meetings," CBI's 6th Annual Pharmaceutical Meeting Management Forum, Philadelphia, PA, March 15, 2010.
  • "What a Pharmaceutical, Biotech and Medical Device Meeting Supplier Must Know - An Introduction to the Regulatory Framework for Medical Meetings," 6th Annual Pharmaceutical Meeting Management Forum, Philadelphia, PA, March 15, 2010.
  • "Update on State Law Initiatives," 2010 Drug Information Association, New York, NY, February 23, 2010.
  • "Update on State Law Initiatives," 2010 Synergistix Users Conference, Fort Lauderdale, FL, February 16, 2010.
  • "Disclosure Requirements and Update on State Laws," The 7th Annual Pharmaceutical Compliance Congress, Washington DC, January 26, 2010.
  • "Overcoming the Challenges of Selling in a New Regulatory Environment," Greater Philadelphia Senior Executive Group Program, Philadelphia, PA, November 19, 2009.
  • "State by State Analysis of Disclosure and Reporting Laws - Complying with State Requirements and Understanding the Interpretation Issues Arising in Each State,"Physician Payments Disclosure and Aggregate Spend Conference, New York, NY, September 30, 2009.
  • "Understand How States View Their Gift Laws and Disclosure Efforts Within the Current Transparency Environment," Panel Moderator, CBI's 3rd Annual Forum on Tracking State Laws and Aggregate Spend, Washington, DC, August 11, 2009.
  • "Compliance with State Licensing and Pedigree Requirements - An Operational Perspective," CBI's 2nd Annual Drug Tracking Summit, Philadelphia, PA, April 28, 2009.
  • "Protecting Against Financial Disclosure Violations by Tracking Aggregate Spend," 5th Annual Pharmaceutical Meeting Management Forum, Baltimore, MD, March 31, 2009.
  • "The Growth of State Restrictions and Reporting Requirements on Sales and Marketing," Coalition for HealthCare Communications, New York City, NY, March 12, 2009.
  • "Update on State Law Requirements," 2009 Synergistix Users Conference, Fort Lauderdale, FL, February 3, 2009.
  • "Update on State Law Initiatives," Pharmaceutical Compliance Congress, Washington, DC, January 27, 2009.
  • "Protect Against Financial Disclosure Violations by Understanding How You Should Track Aggregate Spend," CBI's 2nd Annual West Coast Medical Device and Bio/Pharmaceutical Forum, San Diego, CA, December 8, 2008.
  • "Understand the Evolving Rules and Regulations Surrounding Pharmaceutical and Biotech Meetings," CBI's 2nd Annual West Coast Medical Device and Bio/Pharmaceutical Forum, San Diego, CA, December 8, 2008.
  • "State Wholesaler Distributor Laws and Regulations," AdvaMed Device and Diagnostics Compliance Group Conference, Washington, DC October 17, 2008.
  • "Non-Aggregate Spend Laws Affecting Sales and Marketing Promotion," CBI's 2nd Annual Forum on Tracking State Laws and Aggregate Spend," Washington, DC, August 16, 2008.
  • "Drug and Device Companies Face New Federal Disclosure of Physician Payments,"FDAnews Audio Conference, July 16, 2008.
  • "Analysis of Current and Pending State and Federal Laws and Regulations Regarding Pedigree and Wholesale," CBI's Premier Drug Tracking Summit, Princeton, NJ, May 15, 2008.
  • "Will Paying Physicians for Market Research Be Legal?," CBI's 3rd Annual Pharmaceutical Market Research Summit, Philadelphia, PA, April 28, 2008.
  • "Navigating the Federal and State Regulatory Environment," CBI's 4th Annual Pharmaceutical Meeting Planners Forum, Baltimore, MD, March 18, 2008.
  • "Navigating the Federal and State Regulatory Environment," 2008 Synergistix Users Conference, Fort Lauderdale, FL, February 19, 2008.
  • "State Laws for Sales and Marketing Compliance," CBI's 5th Annual Pharmaceutical Marketing Compliance Congress, Washington, DC, January 29, 2008. Moderator for State Laws for Sales, Marketing & Pricing Track.
  • "Navigate the Federal and State Regulatory Environment for Medical Meetings,"Regulatory Keynote Address, CBI’s Inaugural West Coast Medical Device and Bio/Pharmaceutical Meeting Planners Forum, Costa Mesa, CA, December 10, 2007.
  • "State Law Compliance: Staying Abreast of New Developments and Enforcement Actions," ACI’s Sales & Marketing of Medical Devices Conference, Chicago, IL, November 13, 2007.
  • "Protect Your Sampling Strategy: Enhancing Sales And Marketing Initiatives By Increasing Sample Compliance," ExL Pharma’s 3rd Annual Pharmaceutical Sampling Strategies Conference, Philadelphia, PA, November 9, 2007.
  • "Master Class on Fostering a Living Culture of Compliance," ACI’s Fraud and Abuse in the Sales & Marketing of Drugs Conference, Philadelphia, PA, October 26, 2007.
  • "Update on State and Federal Legislation Regarding Prescription Data Restriction,"Electronic Health Records Summit, Philadelphia, PA, October 22-23, 2007.
  • "Convergence of State and Federal Enforcement," Third Annual Porzio Compliance Forum, Porzio Pharmaceutical Services, LLC, Basking Ridge, New Jersey, September 26, 2007.
  • "State Legislation and Enforcement Initiatives," CBI's Forum on Tracking State Laws and Aggregate Spend, Washington, DC, September 10, 2007.
  • "State Law Developments in Device Marketing Compliance and Enforcement," Panel Moderator, CBI's Medical Device & Diagnostics Marketing Compliance Congress, Washington, DC, June 18, 2007.
  • "Proactively Tracking State Legislative Efforts and Using the Results in Corporate Planning," ACI's State False Claims Summit for Pharmaceutical & Life Sciences Companies and Health Care Providers, New York, NY, May 23, 2007.
  • "State Positions in Regard to Registration and Results Posting for Clinical Research,"Panel Moderator, CBI's 2nd Annual Premier Forum on Clinical Trial Registries and Results Databases Conference, Washington, DC, April 30, 2007.
  • "Comprehensive Overview of State and Federal Legislation Regarding PDRP," Keynote Speaker, CBI’s 2nd Forum on Prescription Data Restriction, Washington, DC, April 27, 2007.
  • "State Regulation of Pharmaceutical Sales and Marketing Practices and Its Impact on Market Research," CBI’s 2nd Annual Pharmaceutical Market Research Summit, Philadelphia, PA, April 25, 2007.
  • "Tailoring Compliance Training to the Company's Products, People and Problems,"ACI's Drug and Device Compliance Boot Camp: Training the Sales Force, New York, NY, April 12, 2007.
  • "Working Throughout the Increasingly Complicated State and Regulatory Codes,"CBI's 3rd Annual Pharmaceutical Meeting Planners Forum, Philadelphia, PA, March 27, 2007.
  • "State Law Regulation of Pharmaceutical Sales & Marketing Practices," Synergistix Users Conference, Ft. Lauderdale, FL, March 6, 2007.
  • "State Regulation of Pharmaceutical Sales and Marketing Practices," CBI's 4th Annual Pharmaceutical Marketing Compliance Congress, Washington, DC, January 30, 2007.
  • "Navigating Compliance Requirements Across State Lines," ACI's 5th National Conference on Avoiding Regulatory Scrutiny in the Sales and Marketing of Medical Devices, Chicago, Illinois, November 29-30, 2006.
  • "Proactive Compliance with State-by-State Marketing Restrictions and Disclosures,"HCPro, Inc., Live Audio Conference sponsored by Pharma Compliance Alert, November 14, 2006.
  • "State Laws Regarding Pedigree and Distribution of Drug Samples," 2006 PDMA Sharing Conference, Scottsdale, Arizona, October 15, 2006.
  • "Understand the Impact of the PhRMA Code and Anti-Fraud Laws on eDetailing," CBI’s 5th Annual eDetailing Conference, Philadelphia, Pennsylvania, September 28, 2006.
  • "Regulation of Marketing and Sales Practices at the State Level," The Food and Drug Law Institute’s Conference on Advertising and Promotion for the Pharmaceutical, Veterinary Medicine, Biologics and Medical Device Industries, Bethesda, Maryland, September 18, 2006.
  • "The Future is Upon Us: Emerging Technologies and Approaches for Complying with Federal and State Pedigree Requirements," Second Annual Porzio Compliance Forum, Porzio Pharmaceutical Services, LLC, Basking Ridge, New Jersey, September 13, 2006.
  • "Compliance Issues for Trainers: PDMA, Sampling & State Regulations," National Conference of the Society of Pharmaceutical and Biotech Trainers, Chicago, Illinois, May 23, 2006.
  • "The Impact of State Government Legislation on Mid-level Practitioners," CBI’s 6th Annual Sample Accountability Conference, Philadelphia, Pennsylvania, May 16, 2006.
  • "Sample Accountability Thought Leaders Discussion," CBI’s 6th Annual Sample Accountability Conference, Philadelphia, Pennsylvania, May 15, 2006.
  • "Federal and State Regulation of Pharmaceutical Sales & Marketing Practices and Recent Prosecutions," American Society for Quality 2006 Spring Quality Conference, Whippany, New Jersey, April 6, 2006.
  • "State Law Regulation of Pharma Sales & Marketing Practices," SRI’s Pharma Compliance for Marketing and Management: OIG, FDA and Other Enforcement Considerations, New Brunswick, New Jersey, April 4, 2006.
  • "eHealth Regulations in the U.S. – Understanding the Evolving U.S. Legislative Landscape," CBI’s 5th Annual eMarketing for the Pharmaceutical Industry, Philadelphia, Pennsylvania, March 6, 2006.
  • "State Laws Impacting Sales & Marketing Compliance," Synergistix User Conference, Ft. Lauderdale, Florida, February 22–23, 2006.
  • "State Regulation of Pharma Marketing Practices and Advertising," CBI’s 3rd Annual Pharmaceutical Marketing Compliance Congress, Washington, DC, January 31, 2006.
  • "Analyze Current Regulations on Sampling to NPs and PAs," CBI’s Second Annual Forum: Target NPs and PAs Through Effective Sales & Marketing Strategies, Philadelphia, Pennsylvania, October 27–28, 2005.
  • "May We Have Your Fingerprints Please? State Laws Governing Pedigree and Authorized Distributors of Record," Pharmaceutical Compliance Forum, Livingston, New Jersey, September 27–28, 2005.
  • "Update on State Laws Impacting Pharmaceutical Marketing & Sales," 2005 PDMA Sharing Conference, Orlando, Florida, September 19, 2005.
  • "Mid-level Practitioners—Managing the Turf Wars of This Emerging Customer Base,"1st Annual Porzio Compliance Forum, Bedminster, New Jersey, September 14, 2005.
  • "Understanding Regulations in Sampling to Nurse Practitioners and Physician Assistants," CBI’s Fifth Annual Sample Accountability Conference, May 16, 2005.
  • "Ensure Compliant Sample Distribution Workshop," Pharmaceutical Marketing Compliance Congress, FDLI and Center for Business Intelligence, Washington, DC, January 31–February 1, 2005.
  • "Identify How State Regulations are Evolving and What that Means for Your Sampling Program," "Understanding Regulations in Sampling to Nurse Practitioners and Other Advanced Practice Nurses Workshop," and "Sample Accountability Thought Leaders Forum," CBI’s Fourth Annual Sample Accountability Conference, May 13–14, 2004.
  • FDA Inspections Pursuant to the PDMA, How to Prepare for Pharmaceutical Marketing Compliance Congress, FDLI and Center for Business Intelligence, Washington, DC, January 26–28, 2004.
  • HIPAA, Marketing and Sales, Center for Business Intelligence, Primary Compliance for Pharmaceutical Manufacturers, Philadelphia, Pennsylvania, September 24–25, 2003.
  • Expert Conference Panel at Opening General Session (topics discussed: OIG, Anti-Kickback statute, HIPAA, Gifts to Physicians, State Enforcement), PDMA Sharing Conference, Salt Lake City, Utah, September 15–17, 2003.
  • "How To Comply With HIPAA Privacy Regulations," Hope House, Dover, New Jersey, June 26, 2003.
  • Sample Accountability Thought Leaders Forum, CBI’s Third Annual Sample Accountability Conference, May 19–20, 2003.
  • "State Regulation of Drug Sampling by Sales Representatives," Institute for International Research Sample Accountability Conference, March 31–April 1, 2003.
  • "Changing the Culture of Non-Compliance," Barnett International Sample Accountability Conference, December 3–4, 2002.

"Transparency – Present and Future," Synergistix 12th Annual Users Conference, Pompano Beach, FL, March 3, 2016.        

 "Mini Summit XV:  Advanced Issues in Applying Analytics – Using the Data to Provide Value and Partner with the Business," Panelist, The 10th International Pharmaceutical Congress and Best Practices Forum, Warsaw, Poland, May 11, 2016.              

Practice

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Bar Admissions

  • New Jersey, 1987
  • Texas, 1985

Education

University of Notre Dame School of Law, South Bend, Indiana, J.D., May 1985

United States Merchant Marine Academy, Kings Point, New York, B.S., with honors, June 1978

Contact Address

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Morristown, NJ 07962-1997

Phone: 973.538.4006

Fax: 973.538.5146