Upcoming Events
Healthcare Compliance Certification Program
October 26-29, 2009 (New Brunswick, NJ)
The Healthcare Compliance Certification Program is a multi-day educational program for compliance professionals and lawyers in the pharmaceutical, biotech, and medical device industries. The Program addresses the issues faced by the pharmaceutical and medical device industries in complying with such standards as the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers (.pdf), the PhRMA Code (.pdf), and the AdvaMed Revised Code of Ethics (.pdf). The program immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as “fraud, waste, and abuse law,” as well as FDA law, so they can understand the legal underpinnings of the compliance programs that they enforce.
What is the benefit to companies and directors for maintaining an effective corporate compliance program? Can directors and trustees be held personally liable for misconduct even if the company has a corporate compliance program? What role should directors play in voluntary or self-disclosures to government agencies? What is involved in an effectiveness review for such programs? What are some of the recommended steps for directors to take to manage these risks? The speakers will discuss the answers to these questions.
Risks to Directors and Trustees of Health Care & Life Sciences Companies:
Corporate Compliance in a Distressed Economy
November 4, 2009
Health care organizations doing business directly or indirectly with the federal government are urged to maintain effective corporate compliance programs as a way to minimize, if not eliminate, non-compliant behavior and to minimize corporate liability risks should non-compliant behavior occur. Delaware court decisions mention directors' role in confirming the adequacy of the company's corporate compliance program. For those health care and life sciences companies with direct or indirect relationships with federal health care programs such as Medicare and Medicaid, the federal DHHS Inspector General is imposing new contractual obligations in certain circumstances where directors are required to confirm that these compliance programs are effective. These new obligations may become the standard in other contexts. The New York State Office of the Medicaid Inspector General (OMIG) also recently published regulations requiring New York Medicaid providers to have compliance programs. In March 2009, OMIG issued the Provider Self-Disclosure Guidance. Find out what is happening with the New Jersey Office of the Medicaid Inspector General.
Past Events
ASLME Third Annual Student Health Law Conference
October 16, 2009 (Newark, NJ)
The American Society of Law, Medicine & Ethics (ASLME) and Seton Hall University School of Law co-sponsored the Third Annual Student Health Law Conference at the Newark, New Jersey campus of Seton Hall Law. The Conference aimed at educating law students about the various career opportunities that are available in the health law sector through a series of informative panels. A wide variety of industries within the health law sector were represented from hospitals, non-profits, and pharmaceutical and medical device companies to government agencies and private law firms.
Eight to a Womb: The Clinical, Ethical and Legal Issues Posed by Multiple Embryo Transfer
April 16, 2009
This candid and informative talk, given by Dr. Mark V. Sauer, the Chief of the Division of Reproductive Endocrinology and Infertility at Columbia University Medical Center, and Tracy Miller, the Executive Director of the Center for Health & Pharmaceutical Law & Policy, provided an overview of assisted reproductive technology and in vitro fertilization, a summary of the facts of the case of Nadya Suleman who recently gave birth to octuplets, and an analysis and discussion of the ethical and constitutional issues posed by regulating reproductive medicine to reduce the number of high-order pregnancies.
Protecting Participants, Advancing Science: An Agenda for Reform of Clinical Research Recruitment and Enrollment
March 23, 2009
Leaders from medicine, industry, academia, consumer organizations, and government attended a one-day forum on policy and ethical issues posed by the recruitment and enrollment of human subjects into research. The participants shared their diverse perspectives and expertise and explored common ground for concrete, practical solutions to advance the protections accorded participants in clinical trials. The day’s discussion will inform the Center’s work on forthcoming articles and white papers addressing the need for reform of policies and institutional practices that govern the financial incentives paid to physician-investigators, including disclosure of such incentives to research subjects.
Using Data to Advance Compliance
March 16, 2009
On March 16, 2009, the Center for Health and Pharmaceutical Law & Policy co-sponsored a program with KPMG on Using Data to Advance Compliance. The program, held in New York City for an audience comprised primarily of hospital leaders in compliance, finance, and in-house legal services, featured a presentation by James Sheehan, Medicaid Inspector General for New York State, who discussed how the Office of Medicaid Inspector General is using data to target and pursue investigations. Experts from KPMG presented practical, concrete strategies for how facilities can use data to advance internal compliance efforts. Ed Kornreich, a partner at Proskauer Rose, examined the implications of data mining for Board fiduciary duties.
Healthcare Compliance Certification Program
March 2-5, 2009
In March, the Healthcare Compliance Certification Program held the first of two four-day compliance training sessions on drug and device compliance and oversight planned for this year. Providing a comprehensive overview of state, federal, and international law governing drugs and devices, the Program covered a broad range of topics, including: state disclosure and marketing laws, product development and promotion, the Anti-Kickback Statute, the False Claims Act, government investigations and enforcement, and the Foreign Corrupt Practices Act. The Program’s faculty included prominent experts from industry, law and consulting firms, and government. More than 75 registrants attended the March Program and over 650 have attended since the Program’s inception in 2004.
New Jersey’s Healthcare Landscape
February 25, 2009
At this presentation to an audience drawn from within and outside the Law School community, Heather Howard, the Commissioner of the New Jersey Department of Health and Senior Services, discussed the effects of the economic downturn on health care in New Jersey and the potential impact the new administration in Washington will have on the State. Commissioner Howard also highlighted several of her Department’s initiatives to stabilize the healthcare delivery system in New Jersey and preserve the healthcare safety net.
Preparing for a Pharmaceutical Response to Pandemic Influenza
October 23-24, 2008
The Seton Hall Law Review, in conjunction with the Gibbons Institute of Law, Science & Technology and the Center hosted a symposium to examine the legal, ethical, and public policy issues related to developing a pharmaceutical response to an influenza pandemic. The two-day symposium explored social responsibility in health and pharmaceutical law, including development and approval of vaccines and antiviral drugs, the allocation of vaccines and antiviral drugs in situations of scarcity, and the role of intellectual property law in promoting international equity in pandemic response efforts. The Symposium brought together representatives from health care, industry, government, and academia for a thoughtful dialogue. Symposium proceedings will be included in a special issue of the Seton Hall Law Review in 2009. The Symposium was funded by a grant from Roche.
Off-Label Promotion of FDA Approved Drugs & Devices: The Good, the Bad & the Ugly
June 20, 2008
This one-day program was offered as a supplement to the June Compliance Certification Program and included an in-depth review of the legal framework underlying off-label promotion activities, the FDA’s 2008 draft guidance governing good reprint practices, and a discussion of various risk mitigation strategies. Paul Kalb, M.D., J.D., of Sidley & Austin, presented the keynote address, Off-Label Investigations and Their Public Health Implications.
Using Data to Advance Compliance: Emerging Practices in Industry and Government
June 4, 2008
The Center’s June program focused on best practices by industry to use data for compliance, and government use of data mining and analysis to enhance oversight. Lori Queisser, Senior Vice President, Global Compliance & Business Practices of Schering Plough and Eileen Erdos, Principal of Ernst and Young, provided insight about how industry can use data to inform internal compliance programs. James Sheehan, New York State Medicaid Inspector General and John Krayniak, Assistant Attorney General, New Jersey Medicaid Fraud Control Unit, spoke about government initiatives to use data to target and pursue enforcement. The program, by invitation only, afforded industry counsel the opportunity to have a dialogue with the region’s two leading state prosecutors.
A Critical Analysis of Deferred Prosecution Agreements & Federal Monitors in the Healthcare Industry: Are They Working?
May 14, 2008
This timely one-day program explored the U.S. Department of Justice’s controversial practice of appointing federal monitors to effect change of certain corporate behavior within the healthcare industry. The program examined the scope of monitors’ authority, the impact on corporate culture and practice as well as the need for additional oversight of the monitors. Expert panelists included, among others, Lynn Shapiro Snyder of Epstein Becker & Green; David Samson, federal monitor to Smith & Nephew; and Austin Byrd, Vice President, Ethics, Compliance and Professional Affairs for Smith & Nephew, Inc.
Improving Access and Equity for Medically Underserved New Jersey Residents
March 11, 2008
Jennifer Velez, the Commissioner of the New Jersey Department of Human Services, gave a lecture highlighting the findings and recommendation of a state subcommittee’s year-long examination of the adequacy of the ambulatory care safety net for low-income and uninsured individuals.
Health Care Compliance Certification Program
February. 25-28, 2008, June 16-19, 2008
In 2008, the Health Care Compliance Certification Program held two four-day compliance training sessions on drug and device compliance and oversight. Providing a comprehensive overview of state, federal and international law governing drugs and devices, the programs covered a broad range of topics, including: state disclosure and marketing laws, product development and promotion, Anti-Kickback and Stark laws, investigations and enforcement, and the Foreign Corrupt Practices Act. The speakers were prominent experts from industry, law and consulting firms, and government. More than 150 registrants attended the February and June sessions.
Drawing the Line Between Physician Education and Product Promotion: Charting a Course for Public Policy
January. 30, 2008
Building on participation from leaders in government, industry, medicine and consumer organizations, the Center held a Forum on drug and device promotion and continuing medical education that facilitated a thought-provoking exploration of policy solutions to enhance transparency and minimize conflicts of interest in drug and device promotion. The Forum also examined the dilemmas presented by industry funding for continuing medical education. Program participants welcomed the opportunity to engage in a candid dialogue with opinion leaders from other sectors who brought diverse perspectives to the roundtable discussion.
The State of New Jersey’s Health Sciences Center: UMDNJ 2008
January 29, 2008
This candid and informative talk, given by Distinguished Guest Practitioner Lester Aron, Senior Vice President and General Counsel of the University of Medicine and Dentistry of New Jersey, included discussion of the role the media plays in reporting health law issues and how private and public institutions are treated differently. The Distinguished Guest Practitioner Series provides health law students an opportunity to discuss health issues with leading area practitioners.