Law Commons^™

Regulating Research With Decisionally Impaired Individuals: Are We Making Progress?, Diane E. Hoffmann, Jack Schwartz, Evan G. Derenzo

Faculty Scholarship

No abstract provided.

Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah

Faculty Scholarship

Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA's spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of postapproval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization …

Introduction: Fifteenth Anniversary Of The Edward V. Sparer Public Interest Law Fellowship Program, Elizabeth M. Schneider

Faculty Scholarship

No abstract provided.

Hormone Replacement Therapy, Or Just Eat More Meat: The Technological Hare Vs. The Regulatory Tortoise, Leticia M. Diaz

Faculty Scholarship

Is meat with its high fat content the real culprit, or is it the FDA-approved growth hormones, the same hormones that have been rejected in Europe, that should bear the blame? Why is eating less meat associated with a lower incidence of many types of cancer? Could it be chemical overload? American women are about five times more likely to develop breast cancer than are women in less developed countries.

Symposium: Advances In Biomaterials And Devices, And Their Financing, Michael S. Baram, Ronald A. Cass, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King

Faculty Scholarship

My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.

Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …

Rules For Research On Human Genetic Variation: Lessons From Iceland, George J. Annas

Faculty Scholarship

Research on genetic variation aims to understand how genes function and requires the comparison of DNA samples from groups of individuals to identify variations that might have importance for health or disease. This work is easier if the samples are linked to accurate medical records and genealogic information. Iceland has medical records for all its citizens going back to World War I and detailed genealogic information going back even further. Because Iceland's small population (270,000) has long been isolated and homogeneous, it is thought by many to be an ideal place to search for disease-related genes. Journalists have cavalierly labeled …

Social Risk And The Transformation Of Public Health Law: Lessons From The Plague Years, Elizabeth B. Cooper

Faculty Scholarship

Acquired Immune Deficiency Syndrome (AIDS) was the wake-up call that disturbed America from its mid-twentieth century slumber concerning the dangers of communicable diseases. Until AIDS was identified in 1981, most Americans felt largely impervious to health threats posed by viruses or bacteria. Polio, smallpox, and tuberculosis had been brought under control by the "magic bullets" of antibiotics and vaccines." We felt more susceptible to the ravages of cancer or the debilitation of heart disease. But, over the last twenty years, the (re)emergence of serious or life-threatening microbial- based conditions such as Ebola, hantavirus, Lyme disease, West Nile virus, and even …

Are Ethics Committee Members Competent To Consult?, Diane E. Hoffmann, Anita J. Tarzian, J. Anne O'Neil

Faculty Scholarship

No abstract provided.

Tobacco, The Food And Drug Administration, And Congress, George J. Annas

Faculty Scholarship

Smoking has been the number-one target of public health professionals in the United States for more than a decade because it is the leading cause of premature death. Nonetheless, no unified public health strategy has been developed. In 1995, with the strong endorsement of President Bill Clinton and Vice President Al Gore, the commissioner of the Food and Drug Administration (FDA), Dr. David Kessler, announced that the agency had jurisdiction over tobacco and would regulate cigarettes as “drug-delivery devices.”1 The tobacco companies objected and sued the FDA, arguing that Congress had not given the FDA jurisdiction over their product. …

Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel

Faculty Scholarship

Despite the continuing "war on drugs," the last decade has witnessed the creation and nationwide spread of a remarkable set of institutions, drug treatment courts. In drug treatment court, a criminal defendant pleads guilty or otherwise accepts responsibility for a charged offense and accepts placement in a court-mandated program of drug treatment. The judge and court personnel closely monitor the defendant's performance in the program and the program's capacity to serve the mandated client. The federal government and national associations in turn monitor the local drug treatment courts and disseminate successful practices. The ensemble of institutions, monitoring, and pooling exemplifies …

Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant

Faculty Scholarship

You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …

Ulysses And The Fate Of Frozen Embryos - Reproduction, Research, Or Destruction?, George J. Annas

Faculty Scholarship

On his 10-year voyage back to Ithaca from the Trojan War, Ulysses was warned by Circe to take precautions if he wanted to hear the Sirens' transfixing song, or there would be “no sailing home for him, no wife rising to meet him, /no happy children beaming up at their father's face.” Ulysses accordingly ordered his men to stop their ears with beeswax and bind him firmly to the mast and instructed them that if he gestured to be set free, they should stick to the original agreement and bind him tighter still. Making an agreement that has as a …