AHLA Pharmaceutical and Medical Device Compliance Manual (Non-Members)

Ela Bochenek (Editor) was the Assistant Dean Graduate and Professional Education at Seton Hall University School of Law at the time this book was written. In this position, she directed the Law School’s global Healthcare Compliance Certificate Programs, oversaw the Law School’s Center for Health and Pharmaceutical Law & Policy and collaborated with faculty, students, industry professionals, and enforcement officials to enhance educational offerings.  She was previously Vice President, Global Compliance at Insmed Incorporated, a global biotech orphan drug pharmaceutical company based in New Jersey, where she led the compliance function. 

Prior to joining Insmed, Ms. Bochenek was a Vice President and Associate General Counsel at NPS Pharmaceuticals, Inc., another global biotech orphan drug company, where she was in charge of the international law department and led the international compliance and commercial functions.  Ms. Bochenek was also Associate General Counsel - International for C.R. Bard, Inc., a New Jersey-based multinational medical device company, where she was responsible for providing legal oversight and counsel to all of Bard's global operations on a variety of commercial and compliance matters.  Before joining Bard, Ms. Bochenek was a member of the International Legal Departments of Schering-Plough and Bristol-Myers Squibb Company.   Prior to that, she practiced at two Philadelphia law firms, Morgan, Lewis & Bockius and Pepper, Hamilton & Sheetz, as a general corporate attorney with a concentration in international business transactions. 

Ms. Bochenek’s law degree is from the University of Pennsylvania Law School, where she was a member of the Law Review. She won the Global Counsel Award 2009 in the Best Individual Commercial Lawyer category; the award is sponsored by the International Law Office and the Association of Corporate Counsel. Ms. Bochenek now serves as Vice President and Chief Compliance Officer at Nabriva Therapeutics.

Carl H. Coleman (Editor) is Professor of Law at Seton Hall University School of Law. He is the lead author of the textbook, The Ethics and Regulation of Research with Human Subjects (2d ed. Lexis 2015), as well as numerous articles on health law and policy in leading legal and heath policy journals. He previously served as Bioethics and Law Advisor at the World Health Organization, as Executive Director of the New York State Task Force on Life and the Law, and as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) of the U.S. Department of Health & Human Services. He received his J.D., magna cum laude, from Harvard Law School, where he was Supervising Editor of the Harvard Law Review.  Following law school, he served as law clerk to the Hon. James L. Oakes, Chief Judge of the U.S. Court of Appeals for the Second Circuit.

Amy Matey (Editor) is the Executive Director of Health Care Compliance Education at Seton Hall University School of Law. In this role, she develops educational programs and events for the Law School’s Center for Health & Pharmaceutical Law & Policy and manages its highly regarded global health care compliance programs. Previously, she was an associate attorney at the law firm of Porzio, Bromberg & Newman. She then served as Assistant Counsel to Governor Chris Christie. She received her B.A. from Rutgers University and her J.D. from Seton Hall University School of Law.

Marc Adler (Chapter 13, Compliance 2.0: Compliance Analytics in the Era of Big Data) is the President and Founder of Global Compliance Strategies where he assists life science manufacturers with establishing and managing global health care compliance programs to ensure compliance with government laws, regulations and expectations.

In addition to serving as an outsourced Global Chief Compliance Officer for life science companies, Mr. Adler oversees a range of outsourced compliance functions and provides guidance on a variety of compliance and health care fraud and abuse matters. He frequently presents and writes on health care compliance, including as faculty for the Seton Hall School of Law Healthcare Compliance Certification Program. Prior to founding Global Compliance Strategies, he led the Healthcare Compliance Service division at one of the largest health care service companies in the world and was responsible for supporting compliance engagements for over 120 life science companies. Mr. Adler received his J.D. from the Seton Hall University School of Law with a Concentration in Health Law.

Joseph S. Calarco (Chapter 13, Compliance 2.0: Compliance Analytics in the Era of Big Data) is Chief Compliance Officer for Neos Therapeutics in Blue Bell, Pennsylvania. In this role, Mr. Calarco is responsible for the establishment and oversight of the U.S. Compliance Program. His responsibilities include the implementation of policies and procedures, education and training, risk assessment activities, monitoring and auditing, and implementation of corrective action initiatives.

Prior to joining Neos Therapeutics, Mr. Calarco was a Director of Compliance Operations at Bristol-Myers Squibb where he led Compliance risk assessment and remediation activities across multiple business units. At Shire Pharmaceuticals he served as a Director of Corporate Compliance where he developed and implemented a Compliance Monitoring and Investigations program. Mr. Calarco received his B.S. in Psychology from Drexel University and Master of Social Service from Bryn Mawr College.

Bret A. Campbell (Chapter 7, International Anti-Bribery and Anti-Corruption), is principal and founder of Northstar Consulting LLC. At Northstar, Mr. Campbell advises clients on corporate governance issues and on the implementation of compliance codes. He helps companies assess risks in their international operations, and counsels on the development and implementation of policies, procedures, and systems designed to prevent and detect potential violations of law. Mr. Campbell also consults on Foreign Corrupt Practices Act  (FCPA) and regulatory compliance due diligence reviews in connection with mergers, acquisitions, and other complex corporate transactions. He has extensive experience managing internal corporate investigations and cross-border criminal and regulatory matters, often in proceedings before the U.S. Department of Justice and the U.S. Securities and Exchange Commission.

Before founding Northstar, Mr. Campbell was a partner in the White-Collar Defense and Investigations group of Cadwalader, Wickersham & Taft LLP and served in various management roles, including as a co-managing partner of the firm’s Washington, DC office. Mr. Campbell received his J.D. from Vermont Law School.

Colleen A. Conry (Chapter 2, Thou Shalt Not Buy Business: The Implications of the Anti-Kickback Statute on the Drug and Device Industry), is a partner in the Litigation and Enforcement Group of Ropes & Gray LLP in Washington, DC. Ms. Conry has extensive experience in representing multinational corporations and their executives in government investigations of potential violations of the Foreign Corrupt Practices Act, export control regulations and anti-money laundering laws, Food Drug and Cosmetic Act, and the various securities fraud statutes, as well as criminal prosecutions for economic espionage or theft of trade secrets. Ms. Conry also advises clients on internal investigations and compliance matters and has worked with clients around the globe across the health care, life sciences, financial services, manufacturing, and telecommunications industries. She worked with her team to obtain a judgment of acquittal at the close of the government’s case for a former associate General Counsel at a major pharmaceutical company who was charged with obstruction of justice and making false statements in connection with a Food and Drug Administration (FDA) inquiry into the company’s marketing practices.

Prior to joining the firm, Ms. Conry served as a Senior Litigation Counsel in the Fraud Section of the Criminal Division in the United States Department of Justice. In 2007, Ms. Conry received the Attorney General’s Award for Distinguished Service and the Federal Bureau of Investigation Director’s Annual Award for Outstanding Criminal Investigation. Prior to joining the Criminal Division, Ms. Conry served for seven years in the Commercial Litigation Branch of the Civil Division where she tried multiple cases involving claims against the government in excess of $3 billion. Ms. Conry received her J.D. from Boston College.

Scott Cunningham (Chapter 5, Drug and Device Development and Approval) is a partner in Covington & Burling's Food, Drug, and Device regulatory practice group.  He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies.  After spending the first twelve years of his career in Washington, DC., Mr. Cunningham now practices in the firm's San Francisco office, where he routinely works with gene therapy, cell therapy, and other innovative regenerative medicine clients.  Mr. Cunningham also has an active pro bono practice representing children in immigration rights cases.

Scott D. Danzis (Chapter 5, Drug and Device Development and Approval) is a partner in the law firm of Covington & Burling LLP, where he is a member of the firm’s Food & Drug practice group.  Mr. Danzis’s practice focuses on medical device regulatory matters, including premarket strategies and postmarket requirements, including advertising and promotion, postmarket reporting, recalls, and enforcement actions, among other things. 

From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration.  He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif.  He holds a Master’s Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.  Following law school, Mr. Danzis clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit.  In addition to his practice, Mr. Danzis is an Adjunct Professor of Law at the Georgetown University Law Center, where he teaches a course on drug and device law.

Sujata Dayal (Chapter 10, Elements of an Effective Compliance Program), is Vice President, Health Care Compliance and Privacy, Pharmaceuticals for Johnson & Johnson in Titusville, New Jersey. In this role, Ms. Dayal is responsible for establishing and overseeing a global compliance program including adopting policies and procedures, conducting training and monitoring, conducting risk assessments and implementing corrective action.

Prior to joining Johnson & Johnson Ms. Dayal worked for Biomet, Inc., Karmact, LLC, Abbott Laboratories, and Jones, Day, Reavis & Pogue. Ms. Dayal received her LL.B from Rajasthan University, India.  She also has a JD from Chicago Kent School of Law and an LL.M. from Columbia University School of Law.

Marc I. Eida (Chapter 9, Federal and State Transparency Laws) is counsel to Porzio, Bromberg & Newman, PC and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department.  He is also the Director of Privacy Services Compliance Associate with the firm’s subsidiary, Porzio Life Sciences, LLC.  Mr. Eida counsels pharmaceutical, medical device, and biotechnology companies on a variety of compliance-related issues, including data privacy, federal and state fraud and abuse laws, FDA promotional regulations, transparency and aggregate spend, industry standards regarding interactions with healthcare professionals, and sampling requirements. 

As a Director with Porzio Life Sciences, Mr. Eida also assists in the creation, development, and implementation of the subsidiary’s products and services.  Prior to joining Porzio Bromberg & Newman, P.C., Mr. Eida was a prosecutor for the Bronx County (Bronx, NY) District Attorney's Office, where he served in both the Appeals and Felony Trial Bureaus.

Jacob T. Elberg (Chapter 1, Enforcement Authorities) has been an Assistant United States Attorney in the District of New Jersey since 2007 and has been Chief of the Office’s Health Care & Government Fraud Unit since 2013. He manages 14 Assistant U.S. Attorneys and directs all of the Office’s criminal and civil investigations and prosecutions of health care fraud offenses, including investigations and prosecutions of fraud against the government and private health insurance plans, illegal kickback schemes, and violations of the Federal Food, Drug & Cosmetic Act, as well as all health care related actions brought by the Office under the False Claims Act. In addition, Mr. Elberg supervises and directs investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs. Mr. Elberg is also an Adjunct Professor at Seton Hall University’s School of Law and is a frequent speaker at industry conferences. 

Prior to joining the United States Attorney’s Office, Mr. Elberg served as a law clerk to the Honorable Nancy Gertner (District of Massachusetts) and worked in private practice at Dwyer & Collora LLP (now Hogan Lovells), where he handled all aspects of complex civil and criminal litigation in federal and state courts. He is a graduate of Dartmouth College and Harvard Law School.

Brett R. Friedman (Chapter 2, Thou Shalt Not Buy Business: The Implications of the Anti-Kickback Statute on the Drug and Device Industry), is a Partner in the Health Care Group and Co-Head of the Digital Health Practice at Ropes & Gray LLP in New York, New York. Mr. Friedman provides legal advice on a variety of transactional, enforcement, and regulatory matters to a broad spectrum of health care clients, including hospitals, managed care plans, pharmaceutical and device manufacturers, pharmacy and dental benefit managers, home care agencies, health IT and telehealth providers, and community-based providers. He also advises clients in the course of government investigations, audits, and self-disclosures concerning potential violations of Medicare and Medicaid regulatory authorities as well as health care fraud and abuse laws. Mr. Friedman routinely counsels clients on the development of health care compliance programs to meet obligations under state and federal corporate integrity agreements, legal standards, and industry best practices. 

Mr. Friedman has conducted numerous compliance program reviews and risk assessments for clients across the health care industry. He also has particular experience counseling both payer and provider clients in responding to the transition to accountable care and value-based payment, including the development of provider risk-bearing organizations, Accountable Care Organizations (ACOs), independent practice associations (IPAs), and other integrated delivery networks. Mr. Friedman also advises private equity, for-profit, and tax-exempt clients regarding health care due diligence, regulatory and reimbursement issues that arise in the course of health care transactions. Mr. Friedman received his J.D. from The George Washington University Law School.

Gary Giampetruzzi (Chapter 7, International Anti-Bribery and Anti-Corruption) is a Global Vice-Chair of the Investigations and White Collar Department in the Litigation Department, as well as the Life Sciences Department at Paul Hastings, based in the firm’s New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters and global compliance transactional due diligence in the United States and internationally, and represents corporations in high-profile U.S. federal and state investigations, including those involving U.S. federal and state False Claims Act (qui tam suits), the FCPA, and other complex litigation matters. While his practice cuts across numerous sectors, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world’s most prominent biotech, pharmaceutical, and medical device companies.

Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc, with responsibility for government investigations across the company’s multiple business units and operations globally, and Deputy Compliance Officer responsible for international compliance investigations and programs. He is highly regarded by counsel, health care industry insiders, and regulators for his strategic thinking and sound judgment, and brings unique experience and perspective to each representation, having himself been the client for more than a decade.

Christopher R. Hall (Chapter 3, False Claims Act), is Partner and Chair of White Collar and Government Enforcement at Saul Ewing Arnstein & Lern LLP in Philadelphia, Pennsylvania. As a former federal prosecutor, Mr. Hall represents corporations and individuals facing allegations of wrongful conduct. He assists clients during internal investigations, government criminal investigations, government civil enforcement actions, and related civil proceedings such as False Claims Act and securities fraud proceedings. He has experience with multi-agency, parallel criminal and civil investigations, including the off-label marketing of pharmaceutical drugs in violation of FDA statutes and regulations, and schemes to defraud federal health care programs and private insurers through the submission of false and inflated claims for reimbursement and payment.

Mr. Hall has a thorough and current understanding of the workings of the FDA, Health and Human Services Office of Inspector General, the Antitrust, Criminal, and Civil Divisions of the Department of Justice, the Securities and Exchange Commission, Internal Revenue Service, Housing and Urban Development, Environmental Protection Agency, and the Departments of Defense, Homeland Security, and Labor. Mr. Hall received his J.D. from Georgetown University Law Center.

Patrick M. Hromisin (Chapter 3, False Claims Act), is an Associate with Saul Ewing Arnstein & Lehr LLP in Philadelphia, Pennsylvania. Mr. Hromisin’s practice is concentrated on government enforcement, internal investigations, and compliance issues across multiple industries. He has represented health care companies, medical device company executives, and skilled nursing facility operators, among others. He has litigated cases involving the False Claims Act, Food, Drug & Cosmetic Act, Health Insurance Portability and Accountability Act (HIPAA), Medicare regulations, state unfair trade practices laws, and numerous other federal and state regulatory schemes. Prior to joining Saul Ewing, he worked in international logistics for the United States Navy.

Mr. Hromisin received his J.D. from Temple University James E. Beasley School of Law.

Mark Krueger (Chapter 12, Interactions with Patient and Patient Organizations), MPH, founded MK&A (Mark Krueger & Associates, Inc.) in 1996 to help pharmaceutical, biotech, device, and diagnostic companies partner meaningfully and compliantly with patient, consumer, and professional groups to speed drug development and approval, promote appropriate use, and ensure equitable access and reimbursement. After 20 years leading MK&A, Mr. Krueger sold the firm, which was then rebranded as VOZ advisors, and now works as an independent consultant.

Bruce A. Levy (Chapter 4, Advertising, Labeling and Promotion), is the Director of the Criminal Defense Department at Gibbons PC in Newark, New Jersey. Mr. Levy has more than 20 years’ experience in criminal, civil, and administrative matters arising from federal and state health care fraud investigations, including government investigations, internal investigations, corporate compliance, and complex civil litigation. He has extensive experience representing pharmaceutical and device manufacturers as well as a variety of health care providers covering a broad range of issues relating to the federal Anti-Kickback Statute, Stark laws, the False Claims Act, the Food, Drug, and Cosmetic Act, and Medicare and Medicaid reimbursement. He also counsels drug and device manufacturers regarding sales and marketing compliance issues relating to interactions with health care professionals and off-label promotion and works with clients to develop and improve compliance plans and compliance training.

Prior to joining Gibbons, Mr. Levy served as an Assistant U.S. Attorney with the U.S. Attorney’s Office for the District of New Jersey from 1991 to 2001 and was the Criminal Health Care Fraud Coordinator from 1995 to 2001. Mr. Levy received his J.D. from New York University School of Law.

Veronica Lopez (Chapter 12, Interactions with Patient and Patient Organizations), MPH, is a director of client services at VOZ Advisors. VOZ Advisors specializes in building equitable and responsible partnerships between industry and patients, advocates, and policy makers while adhering to compliance guidelines and regulations. The firm’s work around the world includes building companies’ advocacy relations capacity; creation of company guidelines and internal operating procedures; and resolving complex challenges around patient, consumer, and professional group outreach in North America, Europe, and other regions of the world. Ms. Lopez has experience guiding pharmaceutical companies in developing comprehensive and compliant codes for interactions with patient organizations. She has a background in public health with a degree in health policy. 

Joseph W. Metro (Chapter 11, Prescription Drug Price Regulation: Key Considerations for Compliance Officers), is a member of the Life Sciences Health Industry Group in Reed Smith’s Washington, DC, office, and practices in the area of health care regulatory law. Mr. Metro’s practice focuses on counseling health care manufacturers, distributors, and providers on reimbursement, regulatory, and fraud and abuse issues.

For more than 15 years, Mr. Metro has provided analysis and counseling on behalf of manufacturers with respect to government pricing matters, including: the Medicaid drug rebate statute, the Veterans Health Care Act’s drug pricing standards, the federal Anti-Kickback Statute, and other state and federal laws relating to the promotion of prescription drugs and medical devices. He has helped companies in various aspects of compliance program development and financial relationship reporting, as well as day-to-day counseling, the preparation of OIG advisory opinion requests, and responses to subpoenas and other internal and external investigations. Mr. Metro received his J.D. from The George Washington University National Law Center.

Gregg Shapiro (Chapter 1, Enforcement Authorities), has been an Assistant United States Attorney in the District of Massachusetts since 2005 and is currently Chief of the Affirmative Civil Enforcement Unit. His work primarily involves health care fraud, including kickbacks and Medicare and Medicaid price reporting violations. Prior to joining the United States Attorney’s Office, Mr. Shapiro served as a law clerk to the Honorable Vaughn Walker (Northern District of California) and worked in private practice and in the Consumer Protection Bureau of the Federal Trade Commission. He graduated from Stanford University and Harvard Law School.

Brian Sharkey (Chapter 9, Federal and State Transparency Laws) is a Principal of Porzio, Bromberg & Newman. He is a member of the firm's Life Sciences Practice Group and is a Vice President of Porzio Life Sciences, a subsidiary of the firm. He counsels life sciences companies on a variety of compliance-related issues, most significantly those relating to global marketing disclosure laws and industry codes. In particular, Mr. Sharkey focuses on helping companies understand and comply with global reporting requirements for transfers of value to health care professionals, health care organizations, and patient organizations. Mr. Sharkey also counsels clients with respect to data privacy laws and their obligations.  

Anna Spencer (Chapter 8, Major Privacy Laws and Their Impact on Life Science Companies) is a partner at DLA Piper and she focuses on data privacy and security matters confronting companies in the health care industry. Ms. Spencer counsels a diverse group of companies, including pharmaceutical and medical device manufacturers, health care providers, health-information technology companies, financial institutions and employers that sponsor group health plans. She helps companies leverage data assets, respond to data breaches and develop rules involving the electronic exchange of health information. She has extensive knowledge of global privacy matters and consumer protection issues and regularly advises companies with respect to HIPAA, Health Information Technology for Economic and Clinical Health (HITECH) Act, and Centers for Medicare & Medicaid Services requirements. She has also defended providers in investigations arising from actions and audits by the Office for Civil Rights, U.S. Department of Health and Human Services.

Ms. Spencer regularly advises clients on privacy and security compliance issues related to cloud computing, mobile applications, big data, health information technology and de-identification of data sets. She also has extensive knowledge of state health information privacy and security laws, including the California Consumer Privacy Act.

Robert E. Wanerman (Chapter 6, Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices), is a Member of the Firm in the Health Care and Life Sciences Practice of Epstein Becker Green PC’s Washington, D.C., office. Mr. Wanerman’s practice concentrates on reimbursement, regulatory, and compliance matters affecting health care manufacturers, service providers, and investors in health care organizations. He has extensive experience counseling clients in matters arising under the Medicare and Medicaid programs, the False Claims Act, clinical research rules, grant administration rules, the Anti-Kickback and Stark laws, HIPAA, and the Emergency Medical Treatment and Labor Act (EMTALA). Mr. Wanerman received his J.D. from New York Law School.

Constance A. Wilkinson (Chapter 6, Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices) is a Member of the Litigation and Health Care and Life Sciences Practices in the Epstein Becker Green Washington, DC office and serves on the firm’s Board of Directors. Ms. Wilkinson focuses her practice on pharmaceutical pricing and investigations, government contracts, and commercial pricing and contracting strategies, including health care fraud and abuse considerations, involving the pharmaceutical, medical products, and biotechnology industries. Ms. Wilkinson advises direct and indirect providers in the health care industry regarding pharmaceutical pricing and policy at the state and federal level, as well as price reporting and program compliance under Medicare Parts B and D, the Medicaid Drug Rebate Program, the 340B Drug Discount Program and the Veterans Health Care Act/Federal Supply Schedule Program, and TRICARE. She has experience with due diligence and internal investigations and audits, criminal fraud and abuse investigations, disclosures and restatements, compliance plans and reviews, technical data rights agreements, and conflict of interest issues.

Ms. Wilkinson has made numerous presentations to government and industry groups on Government pricing issues and has co-authored articles and publications on Government contracting issues, drug pricing developments and specialty pharmacy. Ms. Wilkinson graduated from The George Washington University National Law Center and has been at Epstein Becker Green for more than 30 years.

Christopher D. Zalesky (Chapter 10, Elements of an Effective Compliance Program and Chapter 14, The Art and Science of Health Care Compliance in The Pharmaceutical and Medical Device Industries) is retired from Johnson & Johnson where he served as Vice President, Global Policy & Guidance. He has more than 30 years of medical device and pharmaceutical industry experience in health care compliance, regulatory affairs, and quality assurance. He has published numerous articles on regulatory, FDA, and health care policy matters and has contributed to several successful regulatory policy and legislative initiatives. Mr. Zalesky received his J.D. degree from Widener University School of Law.