Pub Date : 2019-12-16DOI: 10.2499/p15738coll2.133524
F. Ceballos, B. Kramer
Production risk is pervasive in agriculture, yet smallholder farmers lack access to quality insurance. This is due to asymmetric information in markets for indemnity insurance, and high basis risk, limited trust, and poor understanding of index-based insurance. Digital technologies can help overcome these challenges by improving crop monitoring and yield prediction, allowing insurers to provide products that move towards indemnity insurance. Although this can potentially improve demand, it also comes at the risk of introducing adverse selection. We analyze this trade-off by eliciting willingness to pay for both index-based insurance and picture-based insurance (PBI) for visible crop damage through incentivized auctions with smallholder farmers in northwestern India. Participants reveal a higher willingness to pay for PBI than for index-based coverage. Although at commercial rates, demand remains low for either product, PBI improves demand at the subsidized premium levels maintained by India’s national insurance scheme. Moreover, we find no evidence of adverse selection. We conclude that digital technologies can facilitate a shift from index-based insurance to indemnity insurance. By reducing basis risk and strengthening trust and understanding, this can improve demand for crop insurance.
{"title":"From Index to Indemnity Insurance Using Digital Technology: Demand for Picture-Based Crop Insurance","authors":"F. Ceballos, B. Kramer","doi":"10.2499/p15738coll2.133524","DOIUrl":"https://doi.org/10.2499/p15738coll2.133524","url":null,"abstract":"Production risk is pervasive in agriculture, yet smallholder farmers lack access to quality insurance. This is due to asymmetric information in markets for indemnity insurance, and high basis risk, limited trust, and poor understanding of index-based insurance. Digital technologies can help overcome these challenges by improving crop monitoring and yield prediction, allowing insurers to provide products that move towards indemnity insurance. Although this can potentially improve demand, it also comes at the risk of introducing adverse selection. We analyze this trade-off by eliciting willingness to pay for both index-based insurance and picture-based insurance (PBI) for visible crop damage through incentivized auctions with smallholder farmers in northwestern India. Participants reveal a higher willingness to pay for PBI than for index-based coverage. Although at commercial rates, demand remains low for either product, PBI improves demand at the subsidized premium levels maintained by India’s national insurance scheme. Moreover, we find no evidence of adverse selection. We conclude that digital technologies can facilitate a shift from index-based insurance to indemnity insurance. By reducing basis risk and strengthening trust and understanding, this can improve demand for crop insurance.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121600541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-05DOI: 10.2499/9780896293649_08
I. Fofana, S. Odjo, F. Traoré
The evidence on the impact of trade liberalization on gender inequalities is not fully established yet, nor is the impact of gender inequalities on trade policy outcomes. Sociocultural norms, legal barriers, and socioeconomic disadvantages are the main gender-based discrimination that affect the distribution of trade benefits between men and women. This study applied to Niger assesses the distributional effects of trade reforms between men and women and sheds light on the impact of gender-based barriers on the outcome of trade reforms. The Common External Tariff (CET) of the Economic Community of West African States has guided Niger’s trade policy since its implementation in 2015. Thus, the study essentially assesses the impact of the CET reform on gender inequalities in Niger. Focusing on employment levels and earnings, the study finds an increased gender gap under the CET implementation, although the custom union reform leads to positive outcomes for both men and women compared to the baseline. Moreover, gender inequalities result in misallocation of resources in the economy and lead to a loss in economic opportunity for Niger. Thus, closing the gender gap in access to productive resources is likely to generate positive outcomes for Niger.
{"title":"Gender and Trade in Africa: Case Study of Niger","authors":"I. Fofana, S. Odjo, F. Traoré","doi":"10.2499/9780896293649_08","DOIUrl":"https://doi.org/10.2499/9780896293649_08","url":null,"abstract":"The evidence on the impact of trade liberalization on gender inequalities is not fully established yet, nor is the impact of gender inequalities on trade policy outcomes. Sociocultural norms, legal barriers, and socioeconomic disadvantages are the main gender-based discrimination that affect the distribution of trade benefits between men and women. This study applied to Niger assesses the distributional effects of trade reforms between men and women and sheds light on the impact of gender-based barriers on the outcome of trade reforms. The Common External Tariff (CET) of the Economic Community of West African States has guided Niger’s trade policy since its implementation in 2015. Thus, the study essentially assesses the impact of the CET reform on gender inequalities in Niger. Focusing on employment levels and earnings, the study finds an increased gender gap under the CET implementation, although the custom union reform leads to positive outcomes for both men and women compared to the baseline. Moreover, gender inequalities result in misallocation of resources in the economy and lead to a loss in economic opportunity for Niger. Thus, closing the gender gap in access to productive resources is likely to generate positive outcomes for Niger.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"64 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116781894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This discussion paper analyzes the economy-wide impact of a series of agricultural innovations in Malawi. Using an agricultural focused computable general equilibrium model disaggregated to reflect Malawi agro-ecological zones, we simulate three scenarios: one involving smallholders catching up to the production frontier, and two scenarios of agronomic innovations consisting in changes in level and application rate of nitrogen. Our results show a positive impact on the economy following an increase in maize yield and production efficiency under the different scenarios.
{"title":"Modelling the Economy-Wide Impact of Technological Innovation and Mapping Agricultural Potential: The Case of Malawi","authors":"Naomi Mathenge, Fousseini Traore, Ismael Fofana","doi":"10.2139/ssrn.3498192","DOIUrl":"https://doi.org/10.2139/ssrn.3498192","url":null,"abstract":"This discussion paper analyzes the economy-wide impact of a series of agricultural innovations in Malawi. Using an agricultural focused computable general equilibrium model disaggregated to reflect Malawi agro-ecological zones, we simulate three scenarios: one involving smallholders catching up to the production frontier, and two scenarios of agronomic innovations consisting in changes in level and application rate of nitrogen. Our results show a positive impact on the economy following an increase in maize yield and production efficiency under the different scenarios.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"219 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132700608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This paper examines the roles law plays in the strategies food producers pursue to compete for the distribution and delivery of the household meal. It tracks the producers’ use of liberal labour law when they compete by increasing labour flexibility and reducing labour costs. The concern behind the inquiry is whether the convenience of our household meals might come at the expense of a class of vulnerable food workers. The paper identifies the counter to this liberal law and the points at which it seeks to reassert public labour law standards. By researching the field of meal distribution and delivery, rather than analysing just one law, its case study method aims to show how these contrasting laws relate to each other in the socio-legal field of work and how each law might matter realistically to the future of food work. On the empirical evidence, the study finds that what matters now is the elemental struggle to have food work treated as regular employment. Then, it is a matter, for that employment, that it be protected by the terms and conditions of the appropriate award.
{"title":"Regulating Food Work: The New Competition for the Household Meal","authors":"C. Arup","doi":"10.2139/ssrn.3478981","DOIUrl":"https://doi.org/10.2139/ssrn.3478981","url":null,"abstract":"This paper examines the roles law plays in the strategies food producers pursue to compete for the distribution and delivery of the household meal. It tracks the producers’ use of liberal labour law when they compete by increasing labour flexibility and reducing labour costs. The concern behind the inquiry is whether the convenience of our household meals might come at the expense of a class of vulnerable food workers. The paper identifies the counter to this liberal law and the points at which it seeks to reassert public labour law standards. By researching the field of meal distribution and delivery, rather than analysing just one law, its case study method aims to show how these contrasting laws relate to each other in the socio-legal field of work and how each law might matter realistically to the future of food work. On the empirical evidence, the study finds that what matters now is the elemental struggle to have food work treated as regular employment. Then, it is a matter, for that employment, that it be protected by the terms and conditions of the appropriate award.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122282101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-26DOI: 10.2499/p15738coll2.133420
A. Akhter, J. Hoddinott, Shalini Roy
The importance of children’s nutritional status for subsequent human capital formation, the limited evidence of the effectiveness of social protection interventions on child nutrition, and the absence of knowledge on the intra-household impacts of cash and food transfers or how they are shaped by complementary programming motivate this paper. We implemented two, linked randomized control trials in rural Bangladesh, with treatment arms including cash transfers, a food ration, or a mixed food and cash transfer, as well as treatments where cash and nutrition behavior change communication (BCC) or where food and nutrition BCC were provided. Only cash plus nutrition BCC had a significant impact on nutritional status, but its effect on height-for-age z scores (HAZ) was large, 0.25SD. We explore the mechanisms underlying this impact. Improved diets – including increased intake of animal source foods – along with reductions in illness in the cash plus BCC treatment arm are consistent with the improvement we observe in children’s HAZ.
{"title":"Food Transfers, Cash Transfers, Behavior Change Communication and Child Nutrition: Evidence From Bangladesh","authors":"A. Akhter, J. Hoddinott, Shalini Roy","doi":"10.2499/p15738coll2.133420","DOIUrl":"https://doi.org/10.2499/p15738coll2.133420","url":null,"abstract":"The importance of children’s nutritional status for subsequent human capital formation, the limited evidence of the effectiveness of social protection interventions on child nutrition, and the absence of knowledge on the intra-household impacts of cash and food transfers or how they are shaped by complementary programming motivate this paper. We implemented two, linked randomized control trials in rural Bangladesh, with treatment arms including cash transfers, a food ration, or a mixed food and cash transfer, as well as treatments where cash and nutrition behavior change communication (BCC) or where food and nutrition BCC were provided. Only cash plus nutrition BCC had a significant impact on nutritional status, but its effect on height-for-age z scores (HAZ) was large, 0.25SD. We explore the mechanisms underlying this impact. Improved diets – including increased intake of animal source foods – along with reductions in illness in the cash plus BCC treatment arm are consistent with the improvement we observe in children’s HAZ.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"49 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127897086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The development of technologies in the 20th century led to evolution of precision agriculture concept. Nowadays, precision farming is usually associated with the use of GPS and satellite navigation, GIS, unmanned airplanes and drones, variable rate of application, as well as complex and sophisticated computer systems and software. On the other hand, the main question is related to the profitability and efficiency of these technologies and the opportunities for their adoption. The main purpose of the research is to investigate the most popular concepts of precision farming and to analyze the technical and economic efficiency of different technologies based on literature review. The results indicate that the adoption of precision farming technologies is closely related to the farmer’s perception of and needs for institutional support. The promotion of precision farming under the Common Agricultural Policy is necessary in order to overcome the number of economic and environmental challenges and ensure sustainable development and green growth.
{"title":"Precision Farming – Concepts and Perspectives","authors":"R. Beluhova-Uzunova, D. Dunchev","doi":"10.30858/zer/112132","DOIUrl":"https://doi.org/10.30858/zer/112132","url":null,"abstract":"The development of technologies in the 20th century led to evolution of precision agriculture concept. Nowadays, precision farming is usually associated with the use of GPS and satellite navigation, GIS, unmanned airplanes and drones, variable rate of application, as well as complex and sophisticated computer systems and software. On the other hand, the main question is related to the profitability and efficiency of these technologies and the opportunities for their adoption. The main purpose of the research is to investigate the most popular concepts of precision farming and to analyze the technical and economic efficiency of different technologies based on literature review. The results indicate that the adoption of precision farming technologies is closely related to the farmer’s perception of and needs for institutional support. The promotion of precision farming under the Common Agricultural Policy is necessary in order to overcome the number of economic and environmental challenges and ensure sustainable development and green growth.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131305608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The main goal of the paper was to determine local institutions (organizations) and assessment of the level of private transaction costs incurred by beneficiaries of public aid related to the modernization of farms. The research was held in 2012 among 129 farms, which in 2004-2011 benefited from public financial aid in their investment activity. The selected farms were researched with the use of interview questionnaire concerning organisation of farms, obtained economic results, assessment of executed investments and relations of farmers with local institutions of the agricultural environment and the level of transaction costs. An estimation of the level of private transaction costs related to the public aid received in the investment activity was mad, on the basis of information obtained from farmers as part of the interview conducted using the questionnaire. It was found that for farmers the most important in the modernization process of farms were the Centre for Advisory Agricultural Service (CASS) and The Agency for Restructuring and Modernization of Agriculture (ARMA). According to the farmers’ opinion, the main barriers to cooperation with local organizations were the high costs of using their services and the difficult access to the institutions. The estimated level of private transaction costs incurred by the beneficiaries in relation to the acquired investment subsidies was low and should not constitute a barrier to obtaining public aid in the process of modernization of farms. On farms characterized by a lower value of investment outlays, the level of private transaction costs in relation to the acquired investment subsidies was higher than in other groups of farms. The largest share in the structure of estimated private transaction costs was related to the costs of collecting documentation and filling in applications.
{"title":"The Local Institutions and Transaction Costs of Public Aid in the Process of Agriculture Modernisation","authors":"D. Kusz","doi":"10.30858/ZER/109922","DOIUrl":"https://doi.org/10.30858/ZER/109922","url":null,"abstract":"The main goal of the paper was to determine local institutions (organizations) and assessment of the level of private transaction costs incurred by beneficiaries of public aid related to the modernization of farms. The research was held in 2012 among 129 farms, which in 2004-2011 benefited from public financial aid in their investment activity. The selected farms were researched with the use of interview questionnaire concerning organisation of farms, obtained economic results, assessment of executed investments and relations of farmers with local institutions of the agricultural environment and the level of transaction costs. An estimation of the level of private transaction costs related to the public aid received in the investment activity was mad, on the basis of information obtained from farmers as part of the interview conducted using the questionnaire. It was found that for farmers the most important in the modernization process of farms were the Centre for Advisory Agricultural Service (CASS) and The Agency for Restructuring and Modernization of Agriculture (ARMA). According to the farmers’ opinion, the main barriers to cooperation with local organizations were the high costs of using their services and the difficult access to the institutions. The estimated level of private transaction costs incurred by the beneficiaries in relation to the acquired investment subsidies was low and should not constitute a barrier to obtaining public aid in the process of modernization of farms. On farms characterized by a lower value of investment outlays, the level of private transaction costs in relation to the acquired investment subsidies was higher than in other groups of farms. The largest share in the structure of estimated private transaction costs was related to the costs of collecting documentation and filling in applications.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"62 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124575100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Third party certification bodies audit companies to determine compliance with standards. We introduce a model of oligopoly competition between certification bodies, showing that a higher degree of certification body competition results in higher grades. We empirically test this hypothesis using panel data from the British Retail Consortium food program, a leading international food safety standard for food manufacturers, and find evidence that a higher degree of competition between certification bodies is associated with higher audit grades. Grades are lower the first time manufacturers certify, suggesting certification may improve food safety practices. Producers with multiple certified sites obtain higher grades.
{"title":"Certifier Competition and Audit Grades","authors":"Yuqing Zheng, Talia Bar","doi":"10.2139/ssrn.3371279","DOIUrl":"https://doi.org/10.2139/ssrn.3371279","url":null,"abstract":"Third party certification bodies audit companies to determine compliance with standards. We introduce a model of oligopoly competition between certification bodies, showing that a higher degree of certification body competition results in higher grades. We empirically test this hypothesis using panel data from the British Retail Consortium food program, a leading international food safety standard for food manufacturers, and find evidence that a higher degree of competition between certification bodies is associated with higher audit grades. Grades are lower the first time manufacturers certify, suggesting certification may improve food safety practices. Producers with multiple certified sites obtain higher grades.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134127800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Surveys the history of the three tier system within the alcohol industry and Texas laws and regulations specifically related to the manufacture and distribution of beer. Discusses how the growth of the craft beer market has changed the industry and how recent legislation, including SB518, 83rd Regular Session, is affecting growth.
{"title":"Micro-Brew, Macro-Fees: Texas Law Favors Beer Distributors While Curbing Growth and Investment in the Nation's Third Largest Craft Beer Market","authors":"Daniel Pellegrin, Jr.","doi":"10.2139/ssrn.3412197","DOIUrl":"https://doi.org/10.2139/ssrn.3412197","url":null,"abstract":"Surveys the history of the three tier system within the alcohol industry and Texas laws and regulations specifically related to the manufacture and distribution of beer. Discusses how the growth of the craft beer market has changed the industry and how recent legislation, including SB518, 83rd Regular Session, is affecting growth.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114608480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by FDA or proven safe and effective to FDA's standards. (Sometimes this happens because FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the U.S. "gold standard" for "new drug" approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. To them, it seems like nothing more than a sudden and significant price increase in a drug that was already widely available. This reverse sequence happens regularly. Doctors all over the country prescribe medicines for a variety of ailments, not realizing the medicines are supposed to be approved by FDA -- but haven't been. Every time a company finally does the research that FDA requires and enjoys the reward of exclusivity in the marketplace, the public cries foul. Today doctors administer fecal microbiota therapy, using an unapproved stool preparation that has been shipped by a company in Massachusetts. But companies are studying new drugs based on the principle. A recent New York Times article described the looming controversy, quoting doctors and patients who seem to question whether the new drug approval process will be worth its cost. These scenarios force us to confront basic questions about the cost and the benefit of the "new drug" framework. This Article examines the new drug authorities with fresh eyes, with the added benefit of these unusual scenarios where in a sense the gate keeping mechanism has failed. Its principal insights are that, in addition to ensuring the production of high quality evidence about treatments in the marketplace, the new drug authorities (1) ensure the disclosure -- and provide a mechanism for close regulation of the disclosure -- of that information, and (2) give federal regulators a leash on new drugs, and the companies who market them, through the life cycle of those drugs. It explores the costs of error and delay associated with new drug approval and alternatives that some scholars and policymakers have proposed, ultimately arguing that -- though aspects may need tweaking -- the new drug approval paradigm is worthwhile. But these access-before-evidence scenarios bring home the point that the new drug approval standard does not, itself, ensure high quality innovation is performed. Something else must provide the encouragement. It concludes that those who object to temporary exclusivity for new medicines that complete the approval process (and the high prices they make possible for a while) must ask themselves whether they value the new drug framework (including good evidence) as much as they thought.
{"title":"Access Before Evidence and the Price of the FDA's New Drug Authorities","authors":"Erika Lietzan","doi":"10.2139/SSRN.3346574","DOIUrl":"https://doi.org/10.2139/SSRN.3346574","url":null,"abstract":"Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by FDA or proven safe and effective to FDA's standards. (Sometimes this happens because FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the U.S. \"gold standard\" for \"new drug\" approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. To them, it seems like nothing more than a sudden and significant price increase in a drug that was already widely available. \u0000 \u0000This reverse sequence happens regularly. Doctors all over the country prescribe medicines for a variety of ailments, not realizing the medicines are supposed to be approved by FDA -- but haven't been. Every time a company finally does the research that FDA requires and enjoys the reward of exclusivity in the marketplace, the public cries foul. Today doctors administer fecal microbiota therapy, using an unapproved stool preparation that has been shipped by a company in Massachusetts. But companies are studying new drugs based on the principle. A recent New York Times article described the looming controversy, quoting doctors and patients who seem to question whether the new drug approval process will be worth its cost. \u0000 \u0000These scenarios force us to confront basic questions about the cost and the benefit of the \"new drug\" framework. This Article examines the new drug authorities with fresh eyes, with the added benefit of these unusual scenarios where in a sense the gate keeping mechanism has failed. Its principal insights are that, in addition to ensuring the production of high quality evidence about treatments in the marketplace, the new drug authorities (1) ensure the disclosure -- and provide a mechanism for close regulation of the disclosure -- of that information, and (2) give federal regulators a leash on new drugs, and the companies who market them, through the life cycle of those drugs. It explores the costs of error and delay associated with new drug approval and alternatives that some scholars and policymakers have proposed, ultimately arguing that -- though aspects may need tweaking -- the new drug approval paradigm is worthwhile. \u0000 \u0000But these access-before-evidence scenarios bring home the point that the new drug approval standard does not, itself, ensure high quality innovation is performed. Something else must provide the encouragement. It concludes that those who object to temporary exclusivity for new medicines that complete the approval process (and the high prices they make possible for a while) must ask themselves whether they value the new drug framework (including good evidence) as much as they thought.","PeriodicalId":365834,"journal":{"name":"Food Laws","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127926894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：