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Zika And The Regulatory Regime For Licensing Vaccines For Use During Pregnancy, Sam F. Halabi Jul 2017

Zika And The Regulatory Regime For Licensing Vaccines For Use During Pregnancy, Sam F. Halabi

Faculty Publications

Microcephaly and other severe fetal brain defects (congenital Zika syndrome) caused by the Zika virus have prompted an urgent effort to develop and license a safe and efficacious vaccine. Yet, that effort has run up against one of the most formidable barriers in vaccine research: pregnant women are almost always excluded from clinical trials for fear that the intervention may harm the fetus. This article analyzes the existing regulatory framework for vaccines intended for use during pregnancy in an effort to identify ways the process may be reconsidered in light of recent public health emergencies that had a disproportionate effect …


Zika And The Failure To Act Under The Police Power, Jacqueline Fox May 2017

Zika And The Failure To Act Under The Police Power, Jacqueline Fox

Faculty Publications

Zika is a mosquito-borne and sexually transmitted disease that is a dangerous threat to pregnant women, causing catastrophic birth defects in a large percentage of fetuses when their mothers become infected while pregnant. It raises numerous issues related to abortion, birth control, poverty, and women’s control over their procreative choices. While the United States received ample warning from January 2016 onward that it was at risk of local transmission of this virus and public health officials at all levels generally behaved properly, the state and federal legislative responses in the summer of 2016 were entirely inadequate. For example, no state …


Big Data And The Americans With Disabilities Act, Sharona Hoffman Jan 2017

Big Data And The Americans With Disabilities Act, Sharona Hoffman

Faculty Publications

While big data offers society many potential benefits, it also comes with serious risks. This Essay focuses on the concern that big data will lead to increased employment discrimination. It develops the novel argument that the Americans with Disabilities Act (ADA) should be amended in response to the big data phenomenon in order to protect individuals who are perceived as likely to develop physical or mental impairments in the future. Employers can obtain medical data about employees not only through the traditional means of medical examinations and inquiries, but also through the non-traditional mechanisms of social media, wellness programs, and …


Services And Resources For People Living With Hiv/Aids In The Southcoast Of Massachusetts: “Can’T Get There From Here!”, Jason Potter Burda, Margaret B. Drew, Caitlin M. Stover Jan 2017

Services And Resources For People Living With Hiv/Aids In The Southcoast Of Massachusetts: “Can’T Get There From Here!”, Jason Potter Burda, Margaret B. Drew, Caitlin M. Stover

Faculty Publications

Fall River and New Bedford, two diverse and economically challenged cities in the Southcoast region of Massachusetts, are areas of substantial concern in the effort to reduce HIV incidence and to provide effective services for people living with HIV/AIDS in the Commonwealth. In these two communities, HIV disparately impacts marginalized populations, with particularly high infection and prevalence rates among men who have sex with men and injection drug users in comparison to other Massachusetts localities. This project used community engaged research principles to conduct a community assessment guided by the social determinants of health. The primary goal of this study …


Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin Jan 2017

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …


Zika, Pregnancy, And The Law, Sam F. Halabi Jan 2017

Zika, Pregnancy, And The Law, Sam F. Halabi

Faculty Publications

This Essay situates a crucial component of the public health response to Zika - the effort to develop a safe and effective vaccine - within the broader literature. It does so in an effort to highlight the need to revisit the relationship between law and pregnancy - not only in the areas legal scholars have prioritized so far, but also in the context of routine and emergency maternal health, which has heretofore been largely assumed to be governed by straightforward norms and practices based on medical evidence and physician ethics. In fact, whereas the current literature tends to assume or …


Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah Yearby Jan 2017

Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah Yearby

Faculty Publications

No abstract provided.


A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer Jan 2017

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.