Law Commons^™

Developing Product Label Information To Support Evidence-Informed Use Of Vaccines In Pregnancy, Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, Eliana Castillo, Natasha S. Crowcroft, Deshayne B. Fell, Michael Hadskis, Jaelene M. Mannerfeldt, Devon Greyson, Noni E. Macdonald, Karina A. Top, On Behalf Of The Canadian Vaccine Product Monograph Working Group

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Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.

Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.

Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

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Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

Privacy And Legal Automation: The Dmca As A Case Study, Jonathon Penney

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Advances in artificial intelligence, machine learning, computing capacity, and big data analytics are creating exciting new possibilities for legal automation. At the same time, these changes pose serious risks for civil liberties and other societal interests. Yet, existing scholarship is narrow, leaving uncertainty on a range of issues, including a glaring lack of systematic empirical work as to how legal automation may impact people’s privacy and freedom. This article addresses this gap with an original empirical analysis of the Digital Millennium Copyright Act (DMCA), which today sits at the forefront of algorithmic law due to its automated enforcement of copyright …

The Science, Law, And Politics Of Canada's Pathways To Paris: Introduction To Ubc Law Review's Special Section On Climate Change And Canada, Jason Maclean, Meinhard Doelle, Chris Tollefson

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This brief essay introduces two articles comprising a special section of the UBC Law Review on climate change law and policy in Canada.

When Law Frees Us To Speak, Jonathon Penney, Danielle Citron

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A central aim of online abuse is to silence victims. That effort is as regrettable as it is successful. In the face of cyber harassment and sexual privacy invasions, women and marginalized groups retreat from online engagement. These documented chilling effects, however, are not inevitable. Beyond its deterrent function, law has an equally important expressive role. In this article, we highlight law’s capacity to shape social norms and behavior through education. We focus on a neglected dimension of law’s expressive role—its capacity to empower victims to express their truths and engage with others. Our argument is theoretical and empirical. We …