The next sessions for the Seton Hall Law Online Graduate Certificate Programs will commence in February 2012. These 8-week non-degree programs are designed for individuals who seek a greater understanding of key aspects of the health care field.
The Pharmaceutical & Medical Device Law & Compliance Program will begin on February 12, addressing the legal, regulatory and ethical issues related to the pharmaceutical and medical device industries. Priority application deadline is January 26.
The Health and Hospital Law Program will commence online on February 26 and offers an exploration of the legal, regulatory and ethical issues regarding health care delivery. Priority application deadline is February 2.
Click here to learn more about these programs and apply. For information, please contact Helen Cummings, Assistant Dean for Graduate Programs, at helen.cummings@shu.edu or call 973-642-8380.
We are pleased to introduce and welcome Professor Zack Buck to Health Reform Watch. He is a Visiting Assistant Professor here at Seton Hall Law and specializes in various health law topics, focused primarily on issues surrounding mental health law and public health law. Professor Buck teaches health law courses, including mental health law and healthcare fraud and abuse. He holds a J.D. from the University Pennsylvania Law School (2009), a Masters of Bioethics from the University of Pennsylvania (2009), and a B.A. with highest distinction, in Political Science and Journalism, from Miami University (2006). Prior to joining Seton Hall, Professor Buck was a litigation associate at Sidley Austin LLP in Chicago. He is a member of the bar of Illinois (2009) and is a former legal writing instructor at Penn Law (2008-09).
His first post, ACA Litigation, Implications for Medicaid and Mental Health Care, may be found below.
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
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.
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.
Tags: American Society of Law Medicine & Ethics, ASLME, Center for Health and Pharmaceutical Law & Policy, Center White Papers Position Papers Conferences & Presentations, Fourth Annual Student Health Law Conference, Health Care Employment, Health Care Reform, Health Law, Health Reform, Seton Hall Law, Seton Hall University School of Law
Seton Hall University School of Law has announced the appointment of Frank Pasquale as the Schering-Plough Professor in health care regulation and enforcement. Professor Pasquale has been a member of the Seton Hall Law Faculty since 2004 and is the Associate Director of the Center for Health & Pharmaceutical Law & Policy. He has distinguished himself as an internationally recognized scholar in health, intellectual property, and information law. He has made numerous academic presentations at universities across North America and at the National Academy of Sciences. A prolific writer, Professor Pasquale’s work has been featured in top law reviews, books, peer-reviewed journals, and online blogs, including Health Reform Watch, of which he is Editor-in-Chief. A frequent media presence, he has appeared in the New York Times, San Francisco Chronicle, Los Angeles Times, Boston Globe, Financial Times, and on CNN, WNYC’s Brian Lehrer Show, and National Public Radio’s Talk of the Nation.
Professor Pasquale has testified before Congress and before the New York City Broadband Advisory Commission. He has presented before the Task Force on Competition Policy and Antitrust Laws of the House Committee on the Judiciary, appearing with the General Counsels of Google, Microsoft, and Yahoo.
At Seton Hall Law, Professor Pasquale has taught courses in health care finance and regulation, intellectual property law, and administrative law. He received his J.D. from Yale Law School, his M.Phil. from Oxford University, and his B.A. summa cum laude from Harvard University.
As the Schering-Plough Professor in Health Care Regulation and Enforcement, Professor Pasquale will contribute scholarship which will include public policy analysis of issues related to administrative law, the regulatory and enforcement concerns of providers and patients, FDA law, and drug and device innovation.
This Professorship was made possible by a $2.5 million endowment from the former Schering-Plough Corporation and the Schering-Plough Foundation. The Schering-Plough Foundation supported the advancement of health, education, public policy, and community initiatives.
Seton Hall University School of Law’s Leuven-Geneva Program in Health, Intellectual Property and International Law combines a broad-based introduction to the laws, policies and institutions of the European Union (EU) with a unique, interdisciplinary examination of cutting-edge issues in intellectual property, pharmaceutical development and global public health.
The Program will consist of two courses. European Union Law, a two-credit course, will be taught mainly at the Leuven Institute in Leuven, Belgium and will include a special trip to Luxembourg to visit the European Court of Justice. Students will also visit some of the main EU institutions in Brussels, such as the European Parliament and Commission.
The goal of this part of the Program is to introduce students to the essential principles and institutions of the EU and to explore firsthand the challenges facing this unique confederation of different languages and cultures. For the Geneva component of the Program, students will study Health and Intellectual Property Law in a Global Environment, a four-credit course, co-taught by one intellectual property law professor and one health law professor. The course will be conducted in collaboration with Geneva-based international organizations involved in health and intellectual property law issues, including the World Health Organization, UNAIDS, the World Trade Organization and the World Intellectual Property Organization.
Students will work on a series of case studies related to the work of these organizations, both in the classroom and in on-site meetings with organizational representatives. In addition to students from the Seton Hall Program, the Geneva component of the Program will also be open to students from the University of Zurich Ph.D. program in Biomedical Ethics and Law.
More information about the program is available here: http://law.shu.edu/Students/academics/studyabroad/Geneva/index.cfm
Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for major substantive reforms in the financing and oversight of clinical research. In a White Paper entitled “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research.
Kathleen Boozang, a dean who oversees the Law School’s Center, explains that “Some of the ways that drug and device trial sponsors pay the physicians who lead clinical trials can tempt them to recruit individuals for clinical trials who would be better off receiving conventional therapy. This is of particular concern if physicians encourage their own patients to enroll in trials that these same physicians are overseeing.”
Over 60% of testing of experimental drugs and medical devices now occurs in physicians’ private offices; unlike years past, industry funds a much higher percent of clinical trials than government, frequently paying researchers significantly more than government does. For some physician practices, conducting clinical trials represents a significant portion of their income.
According to Carl Coleman, a Seton Hall Law professor who collaborated on the White Paper, “A different kind of problem arises if people are enrolled in trials who don’t meet the criteria for who should participate - these individuals’ health can be put at risk, and their participation can skew the results of the trial, which is bad for everyone.”
Federal regulations in this area have not kept up with the rapid changes in how research occurs, and even those regulations that exist are poorly enforced, according to recent government studies. Understanding that the collaboration among industry, government, and medicine in the pursuit of clinical research is critical to driving scientific progress, particularly as industry increasingly replaces the government as the primary source of research funding, the Center’s recommendations include:
1) Establishing a norm of financial neutrality between treatment and research. Ensuring that physicians receive comparable compensation for treatment and research will help ensure that their decisions to conduct research, as well as to recommend that a particular individual participate in a clinical trial, are grounded in reasons unrelated to their personal financial interests. This will be best accomplished, in the first instance through regulations that ban certain kinds of research compensation, and provide examples of acceptable payment methodologies that industry can follow. Reform by prosecution signals what practices government dislikes, but does not provide a clear vision of ideal approaches to managing conflicts of interest related to the conduct of research.
2) Establishing federal guidelines as to the principles or methodology by which to determine fair market value of physician time spent in clinical work. Federal regulations should be promulgated that establish a benchmark formula for determining fair market value of physicians’ time, effort and expenses for clinical research. Such regulations would promote the goal of financial neutrality between treatment and research. Physicians cannot be underpaid for research either - compensation for clinical trial work should therefore include reimbursement for any additional expenses that are unique to the research environment.
3) Banning payments with equity interests; disqualification of investigators who hold direct interests in the outcome of the research. Federal regulations should prohibit compensation for research in the form of an equity interest in the sponsor of a clinical trial. The law should preclude researchers who have investments that give them a direct interest in the outcome of the research from leading clinical trials. Where absolutely necessary, such individuals might appropriately serve as consultants.
4) Banning payments of finder’s fees and bonuses for recruitment and retention of trial subjects. Certain forms of compensation create conflicts of interest that can incentivize investigators to enroll individuals in a clinical trial who are too healthy or too sick to participate, or to deemphasize information that might discourage individuals from consenting to trial enrollment. Federal law should ban such compensation methods, including finder’s fees and bonuses for meeting recruitment and retention goals.
5) Reforming federal regulations to compel and better guide the evaluation of relationships between industry and would-be physician investigators prior to the commencement of research. The White Paper includes overlapping but sometimes distinctive recommendations for federal regulation to evaluate and oversee investigator or institutional conflicts of interest, both for research within and without academic medical centers. Specific to research outside of academic medical centers, federal regulations should spell out clearly the obligation of community-based physicians acting as investigators or institutions acting on their behalf to report information about compensation for research and other financial interests to Institutional Review Boards.
Summarizing the importance of this White Paper, Boozang states, “The pharmaceutical and medical device industries save millions of lives each year with their innovations. It is imperative that we maintain the integrity of research, and the public’s trust in the process.”
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. The White Paper, “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” may be found here.
Seton Hall University School of Law, New Jersey’s only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching, with a strong focus on clinical education. The Law School’s health law program has been ranked as one of the top programs in the country. Founded in 1951, Seton Hall Law School is located in Newark and offers both day and evening degree programs. For more information visit law.shu.edu.
Tags: Center for Health and Pharmaceutical Law & Policy, Center White Papers Position Papers Conferences & Presentations, Clinical Research, compensation of clinical researchers with company stock, Conflicts of Interest, Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight, Health Care Reform, Health Reform, Seton Hall Law, Seton Hall University School of Law, Transparency, Transparency and Accountability, Transparency Medical Research
The American Society of Law, Medicine & Ethics (ASLME) and
Seton Hall University School of Law will co-sponsor the Third Annual Student Health Law Conference on Friday, October 16, 2009 in Newark, New Jersey, from 8:30AM to 5:00PM.
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.
Click
here for more information.
[Ed. note: mpp.org: "On February 23, the New Jersey Senate voted 22-16 to pass S119, also known as the New Jersey Compassionate Use Medical Marijuana Act. The Assembly health committee voted 8-1 to pass an amended version of the bill on June 4. It must now pass the full Assembly [If the amended bill clears the Assembly, it would return to the Senate for a second vote because of the changes] before it goes to Gov. Jon Corzine (D), who has said that he will sign the bill if it makes it to his desk.”]
Seton Hall University School of Law
Center for Health & Pharmaceutical Law & Policy
Statement In Support of the “New Jersey Compassionate Use Medical Marijuana Act”
The Center for Health & Pharmaceutical Law & Policy supports the passage of the New Jersey Compassionate Use Medical Marijuana Act (the “Act”) because the legislation has been carefully drafted to allow New Jersey residents with debilitating medical conditions access to marijuana to ease their suffering without creating an undue risk of abuse or diversion.
- Medical Evidence. Available medical evidence supports the use of marijuana to treat each of the debilitating medical conditions set forth in the Act: AIDS/HIV; cachexia (wasting syndrome); cancer; glaucoma; severe and persistent muscle spasms; severe nausea; severe or chronic pain; and seizures.
- Need for Access to Marijuana Despite Availability of Cesamet and Marinol Pills. While smoking carries with it certain health risks, smoked marijuana has meaningful advantages over the Cesamet and Marinol pills, which contain synthetic compounds that mimic marijuana’s primary active ingredient. Smoked marijuana is faster-acting, allows for more reliable dosing, and has fewer psychoactive side effects than the pills. In addition, smoked marijuana can be the only option for patients who can not swallow pills due to severe nausea and vomiting as a result, for example, of treatment for cancer.
- Abuse and Diversion. No state that has passed a medical marijuana law has subsequently experienced an increase in recreational marijuana use among its children and youth. The Act’s multiple safeguards against abuse and diversion of medical marijuana provide further reassurance. If passed, the Act would be among the most restrictive of all the states’ medical marijuana laws.
Below please find a brief position paper setting forth the medical evidence and policy arguments in support of the Act.
Seton Hall University School of Law
Center for Health & Pharmaceutical Law & Policy
Position Paper In Support of the “New Jersey Compassionate Use Medical Marijuana Act”
Medical Evidence
Medical evidence supports the use of marijuana to relieve symptoms or ameliorate the side effects of primary treatments of each of the debilitating medical conditions set forth in the Act: AIDS/HIV; cachexia (wasting syndrome); cancer; glaucoma; severe and persistent muscle spasms; severe nausea; severe or chronic pain; and seizures. While conventional treatments are available for some of these conditions for some patients, smoked marijuana has the potential to help those individuals who do not benefit from, or can not tolerate, currently available therapies.[1]
AIDS/HIV and Cachexia (Wasting Syndrome)
Marijuana is an effective treatment for cachexia, also known as wasting syndrome, an involuntary loss of appetite and weight linked to disease progression and death in patients with AIDS/HIV. The American College of Physicians has concluded that abundant support exists for the use of the cannabinoid delta-9-tetrahydrocannabinol (”THC”), one of the primary active ingredients in marijuana, as an appetite stimulant.[2] The FDA concurs, as evidenced by its approval of Marinol, a pill containing a synthetic version of THC, to treat “anorexia associated with weight loss in patients with AIDS.”[3]
Marijuana is also an effective treatment for AIDS/HIV-associated sensory neuropathy, a condition characterized by excruciating pain in the nerve endings that afflicts over a third of patients with AIDS/HIV.[4] In the past two years, three placebo-controlled, randomized, double-blind clinical trials published in the medical literature have demonstrated Read more
We are very pleased to welcome Kate Greenwood, J.D., to the blog today. Kate joined Seton Hall Law School in 2008 as a Faculty Researcher in the Center for Health & Pharmaceutical Law & Policy. She came to Seton Hall from Covington & Burling LLP after having graduated magna cum laude from Georgetown Law where she served as an Articles Editor of The Georgetown Law Journal. She received her undergraduate degree in Economics from Swarthmore College. Prior to her work at Covington & Burling, Kate worked as an Equal Justice Works Fellow and Staff Attorney at the Association of the Bar of the City of New York, and served as a law clerk to the Honorable Mary A. McLaughlin of the Eastern District of Pennsylvania, and to the Honorable Maryanne Trump Barry of the Third Circuit Court of Appeals.
Her work on the legal and regulatory barriers to evaluating existing drugs to determine their safety and efficacy when used during pregnancy and developing new drugs to treat pregnancy complications was selected for presentation at the 2009 St. Louis University Health Law Scholars Workshop
Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for broad reforms in the marketing of drugs and devices. In a whitepaper, entitled, “Drug and Device Promotion: Charting a Course for Policy Reform,” the Center proposes legal and policy changes to address conflicts of interest in the relationship of medicine and industry. “The time is right for reform in the marketing of drugs and devices to doctors,” said Center Executive Director Tracy Miller. “Conflicts of interest have become pervasive in medical practice. Reform is needed to ensure that patients’ interests are at the heart of medical education, practice, and research,” she said.
The Center recommends: (1) making payments by drug and device companies to doctors transparent, with public disclosure by industry and physicians of their financial relationships; (2) adopting federal legislation to ban gifts, meals and other benefits provided to doctors as part of the current marketing model; (3) setting new policies to give FDA the authority to require studies of safety and efficacy of drugs and devices used off-label; and (4) undertaking a fundamental change in funding for continuing medical education to end industry support.
Moving to Transparency. The Center recommends that payments by drug and device companies to doctors should be publicly disclosed. “Transparency is critical to shore up public trust in physicians and the collaboration of industry and medicine,” said Tracy Miller. Transparency would also foster better practices by doctors and industry, advance government oversight, and provide information to the press and public. Pending federal legislation, the Physician Payments Sunshine Act, would require industry to disclose payments to doctors.
The Center supports this approach. It also recommends that states undertake disclosure by doctors, and decide how information about physician financial relationships with industry could best be shared with patients. Law Professor Kathleen Boozang adds that, “If doctors had to disclose payments from industry it would prompt them to examine their practices through the eyes of their patients and peers.”
Banning Gifts, Meals, Perks. The Center proposes adoption of federal legislation to ban the use of gifts, meals, and other perks to promote drugs and devices. The states have taken the lead to date–Massachusetts, California, Minnesota, and the District of Columbia have passed laws to limit or ban gifts and meals that are now routine in marketing practices. Concluding that industry self-regulation is not sufficient, the Center calls for national legislation to create uniform practices by industry and physicians. As urged by Professor Boozang, “the benefits of drugs and devices should drive promotion and physicians’ decision to prescribe, not a marketing model that depends on gifts and meals.”
Promoting Scientific Study of Off-Label Uses. The Center proposes that national policy should be redesigned to assure that physicians, patients and government have reliable information to make informed choices about off-label medications. Estimates suggest that as many as 40% of all prescriptions are for off-label uses. The FDA has recently issued guidelines to promote integrity and accuracy in medical articles that drug and device companies give to doctors. The Center urges that this policy guidance, while useful, does not go far enough to provide crucial information about the safety and efficacy of drugs and devices prescribed by doctors for uses other than those approved by the FDA.
The Center proposes giving FDA the authority to mandate scientific studies for off-label medications and devices that have high sales volumes or large profits but lack needed evidence of efficacy or safety. This would protect the interests of patients and advance sound choices about the risks, benefits, and economic value of off-label uses.
Reforming Funding for Continuing Medical Education (CME). Most states require physicians to undertake continuing medical education to maintain their medical license. The drug and device industry currently funds over half of the accredited CME courses available to physicians. The Center recommends that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians. As stated by Tracy Miller, “Physicians need to retake control of their professional education. CME should focus on doctors as professionals caring for the whole patient, not just as prescribers of drugs and devices.” While the transition to new funding occurs, the Center recommends that speakers at CME events should disclose more information about their financial interests, and physicians who are paid to promote drugs and devices should not speak at CME events about those products.
Factual Background for the Recommendations
- Ninety-four percent of physicians have some kind of financial relationship with industry, as reported in a major recent national study.
- Five states–Maine, Massachusetts, Minnesota, Vermont and West Virginia– have required industry to disclose financial relationships with physicians.
- As shown by a recent Congressional investigation of payments by industry to prominent psychiatrists, even at universities with strong disclosure policies, practices have not kept pace, leaving the public in the dark about financial ties between physicians and industry.
- Medications are widely used off-label, especially in certain fields such as psychiatry, pediatrics, and oncology. A recent study found that 73% of off-label uses lack evidence of efficacy.
- Commercial support for accredited CME, nearly all of it from drug and device manufacturers, grew from $302 million in 1998 to $1.2 billion in 2006.
Read Whitepaper here.
Tags: Ban Gifts, Center White Papers Position Papers Conferences & Presentations, CME, Continuing Medical Education, Drug and Device, Drug and Device Promotion: Charting a Course for Policy Reform, FDA, Off-Label Promotion, Seton Hall Law, Seton Hall University School of Law, Think Tanks, Transparency
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