Congratulations Jordan Cohen ‘11 and Katherine Freed Matos ‘11
Filed under: Health Law, Health Policy Community, Seton Hall Law
Tonight just a fond farewell and congratulations to two of our finest student bloggers: Jordan Cohen and Katherine Freed Matos, both of whom have graduated from Seton Hall Law, with each receiving the much vaunted Health Law Award. They are both now hard at work studying for that fiendish quiz they offer each year at the end of July to see if would be lawyers were paying attention (it is a horrible exercise, I assure you, and if someone you know is studying for the Bar– bring them some food, and leave them alone– they’ll reemerge into the land of the living soon enough). As such, it will be awhile until we hear from them (at least on this blog) again.
After the Bar Exam, Jordan Cohen will be off to employ in the law offices of Brach Eichler, LLC., a preeminent law firm in the New Jersey metro area and a recognized leader in the field of healthcare law.
Katherine Matos has been named to the Office of the Inspector General at the U.S. Department of Health and Human Services, where she will work in the Office of Counsel to the Inspector General, Administrative and Civil Remedies Branch.
You will both be missed. It was a pleasure to work with you, and this blog is better for your having been here. Can’t thank you enough, or wish you enough luck– I expect great things– as it is simply the usual for you both.
And the Winners Are…
Two promising health law students were recently awarded scholarships to attend Seton Hall Law’s Healthcare Compliance Certification Program this June. The program immerses attendees in the laws, regulations, industry codes and compliance standards applicable to the life sciences industry. This year, the scholarships, which are given annually, were awarded to Jenna Smith, a 2L at Loyola University Chicago School of Law, and Abraham Gitterman, a 2L at the University of Maryland School of Law.
For more information on the scholarships and on how students may apply for next year, click here (and scroll down past “Government Scholarships”).
Center News: Greater Newark Healthcare Coalition, Improving Care Through Collaboration
Filed under: Health Policy Community, Health Reform
The Greater Newark Healthcare Coalition is now in its second year and continues to pursue cooperative projects to improve health care for the most vulnerable in the Greater Newark area. Professor John Jacobi serves as the Coalition’s board chair. Other members include a range of health providers, consumer groups, and government agencies. The projects include:
Case management of frequent utilizers of hospital emergency departments. These very fragile patients will benefit from a sophisticated evaluation of their needs and referral to appropriate community placements. Professor Jacobi and Research Fellow and Lecturer in Law Kate Greenwood are working with clinicians on this project, and will produce analysis supporting a reconfiguration of health care funding to both improve care and reduce costs.
Improved prenatal care. The Newark area has a disproportionate number of mothers with poor access to prenatal care.The Coalition is working to bring together various organizations to improve prenatal care.
Preparing physicians for new practice models. Accountable care organizations and patient- centered medical homes require the increased adoption of technology and physician practice patterns that mesh with demands for quality and efficiency. The Coalition will conduct training sessions for area physicians.
The Center’s faculty and students are engaged and committed to lending expert support to the Coalition through legislative and regulatory advocacy and policy development, believing that the fruits of health reform will reach the most vulnerable only if providers, advocates, and regulators work together in cities like Newark.
And the Winners Are…
Filed under: Health Law, Health Policy Community
Two promising health law students were recently awarded scholarships to attend Seton Hall Law’s Healthcare Compliance Certification Program this June. The program immerses attendees in the laws, regulations, industry codes and compliance standards applicable to the life sciences industry. This year, the scholarships, which are given annually, were awarded to Jenna Smith, a 2L at Loyola University Chicago School of Law, and Abraham Gitterman, a 2L at the University of Maryland School of Law.
For more information on the scholarships and on how students may apply for next year, click here (and scroll down past “Government Scholarships”).
Health Reform Watch Welcomes Tara Adams Ragone
Health Reform Watch is pleased to welcome Tara Adams Ragone, Research Fellow and Lecturer in Law here at The Center for Health & Pharmaceutical Law & Policy at Seton Hall Law. Ms. Ragone’s research and writing for the Center will focus on implementation of health care reform, accountable care organizations, health care access, and issues related to the representation of health care professionals. Ms. Ragone comes to us from the State of New Jersey, Office of the Attorney General, Division of Law, where she served as Deputy Attorney General. She handled the prosecution of licensing actions before the State’s professional boards and the Office of Administrative Law. Prior to her work with the Attorney General of New Jersey, Ms. Ragone served as clerk to The Honorable Robert A. Katzmann, United States Court of Appeals for the Second Circuit.
Her first post for HRW can be found immediately below.
Online Graduate Certificate Program in Pharmaceutical & Medical Device Law to Begin in May 2011
After the successful launch of its online program in Health & Hospital Law, Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is set to start again its newest online program, the Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance, on May 1, 2011. Applications are due April 15, 2011.
The Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance is a non-degree program designed for individuals who seek in-depth knowledge about legal, regulatory, and ethical issues related to the pharmaceutical and medical device industries. Taught exclusively online, it offers students nationwide a targeted immersion in key substantive issues along with the practical skills necessary to research and communicate effectively about the law.
The intensive program is geared to busy professionals who want to cover a significant amount of material in a relatively short period of time. The program is open to students who have earned a baccalaureate degree from an accredited college or university. It is specifically designed to meet the needs of mid- to senior-level professionals in the health care industry, but highly motivated students from other backgrounds are also welcome to apply. It is not necessary to have prior academic or work experience in health care in order to do well in the program.
The first class begins May 1, 2011 and applications are being accepted now. Additional information is available here.
New Jersey’s Commissioner of Health and Senior Services Discusses Medical Marijuana and Two Other Regulatory “Case Studies” at Seton Hall Law
Filed under: Health Policy Community, State Initiatives
John V. Jacobi, Dorothea Dix Professor of Health Law and Policy and Faculty Director of the Center for Health and Pharmaceutical Law and Policy at Seton Hall Law School; Dr. Poonam Alaigh, New Jersey Commissioner of Health and Senior Services
On Tuesday, March 1, 2011, New Jersey’s Commissioner of Health and Senior Services Dr. Poonam Alaigh gave a lively and illuminating talk to an audience from within and outside the Seton Hall Law School community. Reflecting her medical training, Dr. Alaigh organized her talk around three “case studies”: (1) the implementation of the New Jersey Compassionate Use Medical Marijuana Act; (2) the rulemaking procedure to amend the hospital licensing standards relating to nurse anesthetists; and (3) the decision by the Department of Health and Senior Services to defer implementation of New Jersey’s menu-labeling law. Two central themes of Dr. Alaigh’s presentation were the remarkable complexity of the legislative and rulemaking processes and the importance of a patient-centered approach to healthcare regulation.
The bulk of Dr. Alaigh’s presentation addressed the unusually extensive back-and-forth between the Department and the Legislature that has characterized the implementation of New Jersey’s medical marijuana law. After the New Jersey Senate invalidated the Department’s initial set of draft regulations, on the grounds that they “would not comply with the intent of the law and would make it much too difficult for eligible patients to access relief through marijuana,” the Department promulgated a revised set of draft regulations reflecting the terms of a bi-partisan compromise. Dr. Alaigh described the massive effort she and her staff — at times, she said, her entire staff — have made to educate themselves about both the science supporting the use of marijuana for medical purposes and the experience of other states with medical marijuana laws. Dr. Alaigh believes the result of the Department’s hard work is a regulatory regime that serves patients in need while avoiding the fraud and criminal diversion problems experienced in California and Colorado. She described New Jersey’s medical marijuana program as the “gold standard” and said that the Department has fielded calls from officials in other states interested in adopting something similar. Among the unique elements of New Jersey’s program is a registry of de-identified patient treatment and outcomes data that will allow researchers to learn more about marijuana’s safety and efficacy.
Dr. Alaigh also spoke about the Department’s rulemaking amending the hospital licensing standards relating to nurse anesthetists. On the one hand, Dr. Alaigh explained, nurse anesthetists are advanced practice nurses who by statute do not require the supervision of a doctor. On the other hand, Dr. Alaigh knows from practice how quickly a patient’s condition can turn critical while under anesthesia. The final regulation provides that nurse anesthetists can administer anesthesia in a hospital setting in accordance with a joint protocol that ensures that an anesthesiologist (1) is available at all times for consultation and (2) is physically present “during induction, emergence and critical change in status.” Dr. Alaigh noted that this result was not likely to have made either anesthesiologists or nurse anesthetists happy. A sign of success for a regulator, perhaps?
The third and final case study that Dr. Alaigh discussed was the Department’s decision not to promulgate draft regulations implementing New Jersey’s menu-labeling law and instead to wait for the federal Food & Drug Administration to implement the menu-labeling provisions of the Patient Protection and Affordable Care Act. As Dr. Alaigh explained in a post on her blog, “[p]ausing to see what the FDA proposes in nine weeks is reasonable. It avoids unnecessary duplication and costs for restaurant owners who would have to invest in new menus and then redo them when the federal rules supersede the state law.” That’s right, Dr. Alaigh has a blog, NJ Health Beat. You can keep up with her here.
The Limits of Disclosure as a Response to Finanacial Conflicts of Interest in Clinical Research
Filed under: Conflicts of Interest, Research
Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has issued a White Paper, “The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research,” in which the Center agrees that public policy should encourage researchers and institutions to make information about their financial relationships with industry available to the public, but-contrary to many other commentators’ recommendations- concludes that disclosure of financial information should not routinely be required as part of the informed consent process.
While reiterating the Center’s prior recommendations for direct measures to eliminate, reduce, and manage problematic financial relationships in clinical research, the Center notes that, despite “the importance of transparency as an ethical value, incorporating financial issues into the informed consent process would provide few, if any benefits to research subjects and could in fact cause significant harms.”
The Center notes the problem of “information overload,” as clinical research informed consent documents have already become “long and complex, thereby confusing and overwhelming potential research participants,” and evidence indicates that “participants are often unable to sift through the morass of information to tease out the content they find salient or material.” In addition, qualitative studies have shown that “brief concise statements about financial interest within informed consent documents were rarely understood, and sometimes only served to confuse potential participants.
The Center concludes that, if a conflict of interest is so serious that its disclosure would lead a reasonable person to refuse to participate in a study, the proper remedy is to eliminate the conflict. It is therefore essential to ensure that information about financial interests is made available to institutional review boards (IRBs) and conflicts of interest committees, so that they can ensure that any problematic conflicts are eliminated before a study begins.
The Center notes that its conclusion that financial conflicts of interest should not be routinely disclosed as part of the informed consent process is not inconsistent with the California Supreme Court’s decision in Moore v. Regents of the University of California.
While Moore creates the possibility that, in the right set of circumstances, a physician’s failure to disclose research-related financial interests could give rise to liability, it does not mean that any and all financial relationships with industry must necessarily be disclosed. Rather, as in any informed consent claim, liability would depend on the plaintiff’s ability to establish the element of causation–i.e., that, if the omitted information had been disclosed, a reasonable person in the plaintiff’s position would not have consented to the procedure. As explained above, under the Center’s proposed framework, any conflict serious enough to affect a reasonable person’s decision about enrollment would already have been eliminated before the research began.
“The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research” may be found at http://law.shu.edu/HealthLawPublications.
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices.
The Center for Health & Pharmaceutical Law & Policy Presents Dr. Poonam Alaigh, New Jersey Commissioner of Health & Senior Services
Filed under: Health Reform, State Initiatives
Tuesday, March 1, 2011
The Center will host a public lecture by NJ Commissioner of Health & Senior Services, Dr. Poonam Alaigh. Prior to serving in the Christie Administration, Dr. Alaigh was the Executive Director at Horizon Blue Cross Blue Shield of New Jersey, responsible for the major clinical areas that ensure the delivery of quality healthcare for its members. Dr. Alaigh has a multifaceted background in health care administration and delivery, including clinical practice, hospital practice, hospital administration, managed care, pharmaceutical medicine, and health care policy. This lecture will be open to students, alumni, and the community, with a reception immediately following.
The lecture will be held from 6:30 to 7:30 p.m., here at Seton Hall Law. To read more about Dr. Alaigh, click here. For reservations please visit http://law.shu.edu/healthlecture.
Strategies for Compliance Professionals: Honing Your Decision-Making Skills
Don’t miss a rare opportunity to participate in real-world exercises and get feedback from recognized healthcare compliance leaders from Merck, Eisai, Johnson &Johnson, Siemens, Epstein Becker & Green, and Ropes & Gray.
WORKSHOP OVERVIEW:
This single-day advanced level training workshop is designed for health care compliance (HCC) professionals wishing to strengthen their analytic and communication skills and foster decision-making capacity.
WORKSHOP OBJECTIVES:
Through this interactive workshop, participants will learn to respond to challenging problems and carry out appropriate corrective action effectively. Participants will work in teams and some pre-work is required.
WHY ATTEND:
- Participate in a unique professional development opportunity designed for HCC professionals seeking to hone analytical, problem solving, and presentation skills.
- Enhance your understanding of the legal, ethical and professional standards that apply to HCC professionals.
- Enrich your professional profile and aid in your professional advancement.
- Prepare and deliver a presentation to a panel of industry experts, including from Siemens, Johnson & Johnson, Eisai, Epstein, Becker & Green, who will provide constructive feedback.
WHO SHOULD ATTEND:
Legal and compliance professionals working for pharmaceutical, medical device and bio companies.
COST & REGISTRATION:
$275 (Includes continental breakfast and lunch)
To register, please go here.
WORKSHOP AGENDA:
- 8:30: Registration & Continental Breakfast
- 9:00-12:00 Morning Session:
- Presentation I: Understanding Your Responsibilities as a HCC Professional
- Presentation II: An Analytical Method for HCC Decision-making
- Group Exercise Instructions
- Overview of Case Studies and Participant Q&A
- 12:00-12:30 Working Lunch
- 12:30-4:30 Afternoon Session
- Team Exercises: case review; identification and analysis of issues & applicable standards;
- Development of Recommendations & Presentation to Management Board
- Team Presentations to Management Board
- Management Board’s Critique of Team presentations
- 4:30 Awarding of Certificates and Conclusion
Seton Hall Law Online Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance - Class Begins January 23, 2011
APPLY NOW!
First Class begins January 23, 2011. Submit your application now.
What is the Online Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance?
The Online Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance is a non-degree program designed for individuals who seek in-depth knowledge about legal, regulatory, and ethical issues related to the pharmaceutical and medical device industries. Taught exclusively online, it offers students a targeted immersion in key substantive issues along with the practical skills necessary to research and communicate effectively about the law. It is an intensive program geared to students who want to cover a significant amount of material in a relatively short period of time.
Who should consider enrolling in the program?
The Online Graduate Certificate is open to students who have earned a baccalaureate degree from an accredited college or university. It is specifically designed to meet the needs of mid- to senior-level professionals in the pharmaceutical and medical device industries, but highly motivated students from other backgrounds are also welcome to apply. It is not necessary to have prior academic or work experience in the pharmaceutical or medical device industries in order to do well in the program.
Why distance learning?
Many professionals in the pharmaceutical and medical device industries are eager to learn about the legal aspects of their professions but cannot realistically commit to spending time attending live classes on a set schedule. Online education offers the ideal solution because students can do their coursework at any time that is convenient for them, day or night. In addition, many students find that they enjoy the interactivity and individualized feedback available through an online educational experience.
Why study pharmaceutical and medical device law at Seton Hall School of Law?
Seton Hall Law School has specialized in health law for more than a decade, and its health law program is consistently ranked among the top ten in the nation by U.S. News & World Report. The Law School’s health law faculty specialize in a wide range of health law topics, including healthcare organizations, nonprofit governance, healthcare financing, healthcare fraud and abuse, food and drug law, research with human subjects, genetics and the law, public health law, and bioethics. In addition to training future lawyers, Seton Hall Law offers a Master’s of Science in Jurisprudence degree for individuals working in the health care industry, as well as an innovative compliance certification program for pharmaceutical and medical device professionals. Seton Hall Law is also a center for scholarship and public policy development related to health care, particularly through its Center for Health & Pharmaceutical Law & Policy, whose mission is to foster informed dialogue among policymakers, consumer advocates, the medical profession, and industry.
Is Seton Hall University accredited?
Seton Hall and its online programs are accredited by the Middle States Association of Colleges and Schools. Seton Hall is a member of the Sloan Asynchronous Learning Network Consortium, an association of accredited institutions offering online degree or certificate programs committed to quality distance education, and is recognized by the U.S. Department of Defense’s education network of Defense Activity for meeting military requirements for Non-Traditional Education Support (”DANTES“).
Seton Hall is fully accredited by the American Bar Association (”ABA”), although, in accordance with Standard 308 of the ABA Standards for Approval of Law Schools, the ABA does not approve any law school program other than the first degree in law (JD). Thus, the ABA accreditation does not extend to any program offered by the Law School other than the JD degree.
APPLY NOW!
First Class begins January 23, 2011. Submit your application now.
Develop Your Lawyering Skills Now and Your Health Law Job Will Follow
Filed under: Health Care Employment, Health Law, Seton Hall Law
On Friday I attended the Fourth Annual Student Health Law Conference: Taking the Health Law Career Path co-sponsored by Seton Hall Law School and the American Society of Law, Medicine & Ethics (ASLME). Originally I planned to attend only the morning session — both for my own benefit as a possible health law practitioner and because I’m a research assistant at the law school’s Center for Health & Pharmaceutical Law & Policy — but I found the panelists to be so engaging that I stuck around for the afternoon session and the networking reception.
Despite some recent good news concerning the job prospects for law students, especially for those in New Jersey, recent graduates and third or fourth year law students don’t need a Magic 8-Ball to tell them that compared to the hiring fests of 2005 and 2006, the present “outlook [is] not so good.” So what about health law jobs? There are regular reports on how the healthcare industry has weathered the economic storm better than others (see Michael Ricciardelli’s blog posts on the continued growth of the healthcare industry here and here). Peter Leibold, Executive Vice President & Chief Executive Officer of the American Health Lawyers Association, delivered a great keynote speech at the Conference emphasizing, among other things, how the field of health law is growing and, in particular, which areas of health law are flourishing.
Still, in the current clime finding a job as a health law practitioner fresh out of law school can seem like a rather daunting challenge. But should it be? Not so, said the panelists.
I attended five panels (out of 18) addressing the career opportunities available for those interested in “When a Medical License is at Stake,” “Health Information & Technology Practice,” “In-House Counsel: Pharmaceutical Companies,” “Government Enforcement of Health Care Fraud, and “Hospitals & Medical Groups: Compliance & Risk Management.” The panelists represented a variety of employers, including the New Jersey Office of the Attorney General, the New York State Office of the Medicaid Inspector General, the United States Attorney’s Office for the District of New Jersey, Bristol-Myers Squibb, sanofi-aventis, Saint Peter’s University Hospital, and Saint Barnabas Health Care System. Three panelists had worked for boutique or large firms but eventually branched out on their own.
Many of the panelists relayed a mixture of humor and frankness in their discussions about the current job market and their own past experiences in job searching. Several noted that their current job came from prior work experiences that had built upon one-another. Others outlined networking strategies and urged students to apply for internships. However, one piece of advice could be heard over and over again: develop your lawyering skills now and your health law job will follow.
Maybe you want to work for a law firm specializing in health law. Maybe you want to be in-house counsel for a pharmaceutical company. Or maybe you want to work for the government. Regardless of which career path appeals to you, a recent law school graduate may hit a wall with potential employers looking for experienced candidates. Both in-house counsel panelists acknowledged that pharmaceutical companies tend to prefer people with a few years of work experience. So if it’s in-house pharma you really want, you’ll just have to work your way there.
So while you search for a health law job, focus on developing a solid set of skills by taking that first job — even if it isn’t in health law — and learning how to be an effective lawyer. That way you will have a marketable set of skills at the ready when a health law job does come your way. Always working towards the goal.
If you’re a recent graduate but you haven’t found a job, it’s suggested that you try the small firms, solo or dual practitioner offices– where you’re as likely as not to have complex files and entire cases dropped in your lap– amounting to invaluable and marketable experience. Barring that, look for freelance work or volunteer your legal services with an organization. It’s better for you to have some legal experience on your resume than none at all. For example, the Division of Law within the New Jersey Office of the Attorney General has a Volunteer Associate Program which enables recent graduates, deferred associates, and similarly-situated attorneys to hone their skills. Participants must commit to 20 hours per week for 3 months. Search around the internet or contact your career services office to find other organizations and government agencies offering similar programs.
Below are some other tidbits of information I gathered from the Conference.
Make yourself an expert and then use social media to market yourself. It is never too early to start making yourself an expert in a particular area of health law. As a health law student or as a recent graduate, you can write articles on topics covered in class and then get your name “out there” by submitting those articles to blogs and other health law news sources. If your articles are published, make sure to maintain a portfolio that you can present to prospective employers and update your resume accordingly. If your articles are published online, you also can create a Twitter account and then make links to those articles. If you doubt the value in that, look up in the right hand corner of this blog and see in “Places Cited” where articles from Health Reform Watch have been cited– everything from the Health Care Blog to the New York Times and Washington Post and Maggie Mahar’s Health Beat. In addition, Seton Hall Law student Jordan Cohen presently holds one of the top rated google searches in America for “Accountable Care Organization.” Not a bad accolade or writing sample to bring a prospective employer.
Intern while you’re in school. Internships are key in this economy. Internships help you develop lawyering skills, add work experience to your resume, provide work references, and give you additional contacts for your job search. Note: if you are interested in working for the government, focus on internships with state and local agencies as well as federal agencies.
Remember your cover letter. To get your foot in the door for an interview, pay attention to your cover letter as well as your resume. This is especially so if your background does not exactly match the position to which you’re applying (e.g., person with public interest background applies for a hospital compliance officer position). Your cover letter presents the best opportunity to answer any questions that might arise in a prospective interviewer’s mind. Be sure to check for typos.
Fourth Annual Student Health Law Conference To Be Held at Seton Hall Law on October 22nd
Filed under: Health Care Employment, Health Law, Seton Hall Law
The American Society of Law, Medicine & Ethics (ASLME) and Seton Hall University School of Law will co-sponsor the Fourth Annual Student Health Law Conference: Taking the Health Law Career Path on Friday, October 22, 2010, in Newark, New Jersey.
This conference, which is attended by law students from law schools throughout the country, seeks to expose law students to the myriad career paths for attorneys in health and life sciences. The conference provides an introductory session on health law, panels on a variety of employment opportunities in health law, and a networking reception with the conference speakers. Career paths that will be represented include academia, compliance, private firms, government agencies, nonprofit organizations, drug and device companies, health insurers, and hospitals. Speakers for this year’s conference have been chosen for their health law expertise and background.
The format of the conference is a series of panels focused around a particular kind of health law career. Each panel is approximately one hour long and comprised of two to four panelists. Students will have the opportunity to explore nontraditional employment opportunities across the health law spectrum, receive support and guidance from professionals familiar with the experience needed for various careers as well as recruitment and hiring processes, and network with health law attorneys.
Interested in learning more about career paths for attorneys in health and life sciences? Click here for information on attending the conference.
Center for Health & Pharmaceutical Law & Policy Submits Comments on Conflicts of Interest in Research to the National Institutes of Health
Filed under: Conflicts of Interest, Health Reform
On August 19, 2010, on behalf of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Seton Hall Law Professors Kathleen Boozang and Carl Coleman, along with Research Fellow Kate Greenwood, submitted comments on the National Institutes of Health’s proposed revisions to its regulations governing conflicts of interest in federally-funded research. While the Center’s November 2009 White Paper Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight endorsed limits on conflicts of interest beyond those that the NIH has proposed, the revised regulations are a step in the right direction and in its comments the Center commends the NIH for its decisive action on this issue.
Briefly, the Center:
- Supports the NIH’s proposal that that researchers disclose to their institutions any significant financial interest that “reasonably appears to be related to the Investigator’s institutional responsibilities,” with “institutional responsibilities” defined to include “activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.” This comports with the Center’s recommendation in the White Paper that investigators not be charged with determining for themselves whether one or more of their financial interests could be affected by a specific research project.
- Supports the NIH’s decision to significantly lower the monetary threshold at which a researcher’s financial interest becomes “significant” to $5,000, but argues that a lower threshold would be better. Collection of data about all of a researcher’s relationships with industry, even those that fall below the proposed $5,000 threshold, would facilitate better conflict of interest assessment and management and make possible research into the effects of conflicts on research integrity and human subject welfare.
- Supports the NIH’s decision not to exclude income from non-profit entities for lectures and similar engagements from the definition of significant financial interest and its conclusion that any equity interest in a non-publicly traded entity is significant, as are any and all intellectual property rights, but encourages the agency to revisit its decision to shield from disclosure (1) equity interests held by investigators in commercial or for-profit institutions and (2) royalties and other remuneration other than salary paid to an investigator by an institution that appoints or employs him or her.
- Notes that the draft revised regulations do not address the White Paper’s criticisms that the conflict of interest regulations place no “substantive limits on the kinds of conflicts that may exist” and fail to put forth “a required minimum response for conflicts that pose the greatest risks to participants and the integrity of the research” and encourages the NIH to consider again the benefits of setting forth required minimum responses to those conflicts that are the most problematic.
- Supports the NIH’s decision to require that grantees provide “sufficient information to enable the [agency] to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution’s management plan.”
- Supports the requirement in the draft revised regulations that any significant financial interest that (1) is still held by a principal investigator or senior/key person, (2) is related to PHS-funded research, and (3) is a financial conflict of interest must be disclosed to the public via the world wide web.
- Supports the draft revised regulations’ requirement that investigators complete training on “the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations” before the commencement of research and then at least once every two years. As recommended in the Center’s White Paper, it would be beneficial for the training to include as well a discussion of the nature of conflicts of interest and their potential for harm.
- Recommends that the agency adopt its own suggestion that institutions be required to “maintain up-to-date, written, enforced policies” on institutional conflicts of interest, as they are for investigator conflicts, and that these policies be made publicly available via the world wide web. The nudge this requirement would provide is necessary because institutions have been slow to develop and adopt policies on institutional conflicts.
- Recommends that the section of the regulations devoted to remedies be revised to include a non-exclusive list of potential enforcement actions such as temporary withholding of cash payments pending correction of the deficiency, suspension or termination of the contract or grant in whole or in part, monetary assessments and penalties, and suspension or debarment from eligibility for future contracts or grants.
The Center’s comments in their entirety are available here.
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy. The Center is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices.
Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Filed under: Compliance, Health Law, Seton Hall Law
Press Release: Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Co-presented by:
Seton Hall School of Law and Sciences Po
June 21 - 25, 2010- Sciences Po, Paris, France
- www.sciences-po.fr/spf/healthcare
PRESS RELEASE
Phone: 973.642-8863
E-mail: simone.handler-hutchinson@shu.edu
Website: law.shu.edu/Paris OR www.sciences-po.fr/spf/healthcare
The Healthcare Compliance Certification Programme, co-organized by Sciences Po Executive Education (Paris, France) and Seton Hall University School of Law (Newark, N.J) to be held from June 21-25, 2010 on the Paris campus of Sciences Po today announced its 2010 topics and faculty.
FEATURED FACULTY:
CURRENT & FORMER REGULATORY & ENFORCEMENT OFFICIALS:
Paul McNulty, Partner, Baker & McKenzie, LLP (DC) Former U.S. Deputy Attorney General
Kirk Ogrosky, Partner, Arnold & Porter LLP (DC), Former Deputy Chief, Health Care Fraud, Criminal Division, U.S. Dept. of Justice
INTERNATIONAL ORGANIZATIONS
Alex Conte, Senior Legal Analyst, Anti-Corruption Division, OECD
Dr. Guitelle Baghdadi-Sabeti, Team Leader, Good Governance for Medicines, World Health Organization
Marie-Claire Pickaert, Deputy Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
COMPANY COMPLIANCE PROFESSIONALS:
Dirk Brinckman, Assistant General Counsel, Johnson & Johnson (Brussels)
Roeland Van Aelst, Vice President, EMEA & Canada, Office of Health Care Compliance & Privacy, Johnson & Johnson
KEYNOTE & ACADEMIC SPEAKERS:
Paul Benkimoun, Healthcare Journalist, Le Monde
Claude Le Pen, Professor, Université Paris-Dauphine
Kathleen Boozang, Professor of Law, Seton Hall Law School (Newark, NJ)
LEADING LEGAL AND COMPLIANCE COUNSEL AND ADVISORS:
Peter W.L. Bogaert, Managing Partner, Covington & Burling (Brussels)
John Rupp, Partner, Covington & Burling LLP (London)
Karolos Seeger, Partner, Debevoise & Plimpton LLP (London)
Susie Smith, Bevan Brittan LLP (UK)
Ted Acosta, Leader, Life Sciences & Corporate Compliance Fraud Investigation & Dispute Services, Ernst & Young LLP
Jill Deal, Partner, Venable LLP (DC)
Kristof Van Quathem, Data Protection Advisor, Covington & Burling LLP (Brussels)
Carolyn Lindsey, Director of Member Services, TRACE International
Owen Bevan, Director, Legal & Compliance Practice, Corporate Executive Board
PROGRAMME CURRICULUM:
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Posts from Health Reform Watch have been cited by media sources throughout the country, including The New York Times, Washington Post, L.A. Times, Kaiser Health News, The Health Care Blog, NPR's Planet Money Blog, Duke Univ. Med. Center News, American Health Line Alerts, BusinessWeek.com, Concurring Opinions, Balkinization, The New England Journal of Medicine, Harvard's Nieman Foundation for Journalism, Las Vegas Sun, Maggie Mahar, Ezra Klein, Tom Geoghegan, and the official homepage of the Office of the Democratic Majority Leader of the House of Representatives, Steny Hoyer.
