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Papers by Micah Berman
Tobacco Regulatory Science, 2019
SSRN Electronic Journal
Drug and Vaccine Development and Access SUMMARY. This Chapter explains how drugs and vaccines for... more Drug and Vaccine Development and Access SUMMARY. This Chapter explains how drugs and vaccines for COVID-19 can reach the market in the United States. As is always true, drug and vaccine manufacturers may seek U.S. Food and Drug Administration (FDA) approval of their products via traditional approval mechanisms and drug manufacturers may offer pre-approval access under the expanded access or right to try pathways. In a public health emergency like COVID-19, an additional mechanism is also available: the Emergency Use Authorization (EUA) pathway. This Chapter (1) assesses how FDA has used its EUA authorities for COVID-19 drugs thus far, (2) considers how FDA has balanced the need for robust evidence of safety and effectiveness for COVID-19 pharmaceuticals against the urgent need to speed patients' access amid the clinical and political realities of the pandemic, and (3) highlights considerations specific to vaccines should FDA be faced with a request to issue an EUA for a COVID-19 vaccine. The Chapter concludes with recommendations for policymakers and regulators at the federal and state levels. The recommendations aim to improve public understanding of the regulatory process for COVID-19 drugs and vaccines, protect scientific decision making from undue political pressure, and ensure that manufacturers develop robust evidence of safety and effectiveness-and ultimately safe and effective COVID-19 countermeasures.
Tobacco Control, 2013
We attempted to estimate the excess annual costs that a US private employer may attribute to empl... more We attempted to estimate the excess annual costs that a US private employer may attribute to employing an individual who smokes tobacco as compared to a non-smoking employee. Reviewing and synthesising previous literature estimating certain discrete costs associated with smoking employees, we developed a cost estimation approach that approximates the total of such costs for U.S. employers. We examined absenteeism, presenteesim, smoking breaks, healthcare costs and pension benefits for smokers. Our best estimate of the annual excess cost to employ a smoker is $5816. This estimate should be taken as a general indicator of the extent of excess costs, not as a predictive point value. Employees who smoke impose significant excess costs on private employers. The results of this study may help inform employer decisions about tobacco-related policies.
addressing non-medical determinants of health is long overdue. Unfortunately, though, nothing in ... more addressing non-medical determinants of health is long overdue. Unfortunately, though, nothing in the Affordable Care Act signaled a paradigm shift. The Affordable Care Act did include a variety of provisions and programs focusing on public health, primarily in Title IV of the Act. These provisions, however, constructed the concepts of "prevention" and "public health" in a limited and narrow way-one that is misaligned with the way that most public health experts would conceptualize their field. 7 As a result, the public health measures included in the Act are unlikely to be effective in reducing the prevalence of the most deadly and expensive chronic diseases. Part I of this article will briefly summarize the argument that I have recently made elsewhere with respect
Tobacco Regulatory Science, 2019
SSRN Electronic Journal
Drug and Vaccine Development and Access SUMMARY. This Chapter explains how drugs and vaccines for... more Drug and Vaccine Development and Access SUMMARY. This Chapter explains how drugs and vaccines for COVID-19 can reach the market in the United States. As is always true, drug and vaccine manufacturers may seek U.S. Food and Drug Administration (FDA) approval of their products via traditional approval mechanisms and drug manufacturers may offer pre-approval access under the expanded access or right to try pathways. In a public health emergency like COVID-19, an additional mechanism is also available: the Emergency Use Authorization (EUA) pathway. This Chapter (1) assesses how FDA has used its EUA authorities for COVID-19 drugs thus far, (2) considers how FDA has balanced the need for robust evidence of safety and effectiveness for COVID-19 pharmaceuticals against the urgent need to speed patients' access amid the clinical and political realities of the pandemic, and (3) highlights considerations specific to vaccines should FDA be faced with a request to issue an EUA for a COVID-19 vaccine. The Chapter concludes with recommendations for policymakers and regulators at the federal and state levels. The recommendations aim to improve public understanding of the regulatory process for COVID-19 drugs and vaccines, protect scientific decision making from undue political pressure, and ensure that manufacturers develop robust evidence of safety and effectiveness-and ultimately safe and effective COVID-19 countermeasures.
Tobacco Control, 2013
We attempted to estimate the excess annual costs that a US private employer may attribute to empl... more We attempted to estimate the excess annual costs that a US private employer may attribute to employing an individual who smokes tobacco as compared to a non-smoking employee. Reviewing and synthesising previous literature estimating certain discrete costs associated with smoking employees, we developed a cost estimation approach that approximates the total of such costs for U.S. employers. We examined absenteeism, presenteesim, smoking breaks, healthcare costs and pension benefits for smokers. Our best estimate of the annual excess cost to employ a smoker is $5816. This estimate should be taken as a general indicator of the extent of excess costs, not as a predictive point value. Employees who smoke impose significant excess costs on private employers. The results of this study may help inform employer decisions about tobacco-related policies.
addressing non-medical determinants of health is long overdue. Unfortunately, though, nothing in ... more addressing non-medical determinants of health is long overdue. Unfortunately, though, nothing in the Affordable Care Act signaled a paradigm shift. The Affordable Care Act did include a variety of provisions and programs focusing on public health, primarily in Title IV of the Act. These provisions, however, constructed the concepts of "prevention" and "public health" in a limited and narrow way-one that is misaligned with the way that most public health experts would conceptualize their field. 7 As a result, the public health measures included in the Act are unlikely to be effective in reducing the prevalence of the most deadly and expensive chronic diseases. Part I of this article will briefly summarize the argument that I have recently made elsewhere with respect