Online Graduate Certificate Program in Health & Hospital Law to Launch in April 2010

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is set to launch a new online program in Health & Hospital Law. The new Graduate Certificate in Health & Hospital Law is a non-degree program designed for individuals who seek in-depth knowledge about legal, regulatory, and ethical issues related to health care delivery.  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 April 18, 2010 and applications are being accepted now. Additional information is available at: law.shu.edu/onlinecertificate

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy Releases White Paper Recommending Reform of Drug and Device Promotion

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.

Seton Hall Law Professor William E. Garland, 64

Seton Hall University School of Law mourns the passing of one of its most beloved professors, William E. Garland. Dean Patrick E. Hobbs said, “Professor Garland was a phenomenal teacher of future attorneys. He knew the law, but more important, he knew how to inculcate professionalism and an ethical sense in his students. He was also extraordinarily patient, demanding from his students the precision necessary to be a good lawyer. His loss affects the entire legal and academic communities, as he was also very involved in law reform efforts, as well as public service. Even with his vast accomplishments, Bill was nothing less than a great man whose company you always enjoyed.”

Born in 1944, Professor Garland earned his Juris Doctor from Seton Hall University in 1969. He joined Seton Hall Law as an adjunct professor in 1970 and became a full professor in 1976. He served as associate dean from 1983 to 1984. Prior to joining Seton Hall Law, Professor Garland was a partner in Stanziale and Garland, a law firm in Newark. He served as the long-time representative of Seton Hall University to the New Jersey Law Revision Commission. The American Bar Association’s Central and Eastern European Law Institute called upon Professor Garland’s expertise in property law and commissioned him to prepare a commentary for Romanian legislators regarding that country’s expropriation law. He was a member of Academics for the Second Amendment and the Foundation for Individual Rights in Education.

Over the years, Professor Garland taught many classes, but was most noted for teaching property and bankruptcy courses. He was also instrumental in the formation and multi-decade success of Seton Hall Law’s Legal Education Opportunity (LEO) program, tailored to provide gifted law school aspirants from economically and educationally challenged backgrounds with the opportunity to demonstrate their ability to succeed in the study of law. Professor Garland often referred to his participation in the LEO program as one of the highlights of his legal career.

The qualities of Professor Garland were best expressed by his former law school classmate and colleague, Dean-Emeritus Ronald Riccio, who said, “Bill Garland loved Seton Hall Law and had a heart of gold. No one was better at attention to detail. He was a superb lawyer, teacher, and good friend. He loved coming to work. His enthusiasm for the law, debate, and genuine affection for people, will be missed deeply.”

Professor Garland is survived by his sister, Sister Barbara Garland, SC, Councilor of the Sisters of Charity at the Convent of St. Elizabeth in Convent Station, NJ.

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