Daniel B Kramer, Yongtian T Tan, Chiaki Sato, Aron S Kesselheim
Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.
{"title":"Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.","authors":"Daniel B Kramer, Yongtian T Tan, Chiaki Sato, Aron S Kesselheim","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 1","pages":"1-23, i"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4091615/pdf/nihms594462.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32296287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Julie Ralston Aoki, Shari A Dawkins, Susan K Bishop
In 2010, the Institute of Medicine (IOM) recommended that the Food and Drug Administration modify the generally recognized as safe status of sodium by setting gradually decreasing limits on sodium amounts allowed in processed and prepared foods. Establishing limits on sodium uses would lead to a decrease in sodium intake, which, on average, far exceeds dietary recommendations. This article discusses the historical and regulatory context surrounding the IOM's recommendation, analyzes its potential, offers various strategies for implementing it, and concludes that the IOM's recommendation is likely the best tool currently available to achieve widespread sodium reductions in the food supply.
{"title":"Implementing the IOM's recommendations for reducing sodium in the U.S. food supply: considerations and approaches.","authors":"Julie Ralston Aoki, Shari A Dawkins, Susan K Bishop","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In 2010, the Institute of Medicine (IOM) recommended that the Food and Drug Administration modify the generally recognized as safe status of sodium by setting gradually decreasing limits on sodium amounts allowed in processed and prepared foods. Establishing limits on sodium uses would lead to a decrease in sodium intake, which, on average, far exceeds dietary recommendations. This article discusses the historical and regulatory context surrounding the IOM's recommendation, analyzes its potential, offers various strategies for implementing it, and concludes that the IOM's recommendation is likely the best tool currently available to achieve widespread sodium reductions in the food supply.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 1","pages":"53-85, ii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32296290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Remarks at the Annual Conference of the Food and Drug Law Institute.","authors":"Margaret A Hamburg","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 3","pages":"343-9"},"PeriodicalIF":0.3,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34706550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This article analyses in its first part the almost dramatic increase of Chinese outbound investments in recent years with a special focus on the food industry. The second part outlines China's legal framework that has governed Chinese outbound investments over the past decade. In its main part this article explores recent steps to liberalize China's economy and assesses how the dismantling of existing restrictions will impact on Chinese investments overseas. It forecasts rather wide-ranging consequences for the non-Chinese food industry as food enterprises have become highly-sought after targets of Chinese outbound investment activities.
{"title":"Chinese Outbound Investments in the Food Sector: Hungry for Much More!","authors":"Lutz-Christian Wolff","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article analyses in its first part the almost dramatic increase of Chinese outbound investments in recent years with a special focus on the food industry. The second part outlines China's legal framework that has governed Chinese outbound investments over the past decade. In its main part this article explores recent steps to liberalize China's economy and assesses how the dismantling of existing restrictions will impact on Chinese investments overseas. It forecasts rather wide-ranging consequences for the non-Chinese food industry as food enterprises have become highly-sought after targets of Chinese outbound investment activities.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 3","pages":"399-428, i-ii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34706553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The 1860 Adulteration Act in England and the 1906 Pure Food and Drug Act in the United States were two of the earliest pieces of legislation to provide generalized regulation of food and drugs on a national scale. While significant scholarly attention has been given to explaining the factors and forces that led to the passage of each Act independent of the other, few books or articles have directly compared the similar individuals and events that led to the adoption of both Acts. This paper attempts to fill that gap. Through a comparative examination, this paper reveals that four main components were key to the national pure food and drug movements in both countries: individuals who crusaded for national adulteration legislation; tragedies that shocked the public into calling for reform; press and publicity that was willing and able to bring the evils of adulteration to the forefront of the public mind; and a transformation of the social, political, and economic systems, which created atmospheres conducive to reform. This paper aims to shed new light on the 1860 Adulteration Act and the 1906 Pure Food and Drug Act--two acts that derive their importance not just from the effect that they directly had on the regulation of food and drugs but also as some of the earliest examples of western governments coming to recognize the need for national regulation to protect the public from harm and coming to embrace their changing role as spearheads of modern regulatory states.
{"title":"Tragedy, transformation, and triumph: comparing the factors and forces that led to the adoption of the 1860 Adulteration Act in England and the 1906 Pure Food and Drug Act in the United States.","authors":"Jillian London","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The 1860 Adulteration Act in England and the 1906 Pure Food and Drug Act in the United States were two of the earliest pieces of legislation to provide generalized regulation of food and drugs on a national scale. While significant scholarly attention has been given to explaining the factors and forces that led to the passage of each Act independent of the other, few books or articles have directly compared the similar individuals and events that led to the adoption of both Acts. This paper attempts to fill that gap. Through a comparative examination, this paper reveals that four main components were key to the national pure food and drug movements in both countries: individuals who crusaded for national adulteration legislation; tragedies that shocked the public into calling for reform; press and publicity that was willing and able to bring the evils of adulteration to the forefront of the public mind; and a transformation of the social, political, and economic systems, which created atmospheres conducive to reform. This paper aims to shed new light on the 1860 Adulteration Act and the 1906 Pure Food and Drug Act--two acts that derive their importance not just from the effect that they directly had on the regulation of food and drugs but also as some of the earliest examples of western governments coming to recognize the need for national regulation to protect the public from harm and coming to embrace their changing role as spearheads of modern regulatory states.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 2","pages":"315-42, ii-iii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32618602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Food and Drug Administration (FDA)'s 510(k) program based upon substantial equivalence review is by far the dominant pathway to market among medical devices requiring premarket review. Substantial equivalence review has been much criticized, but this article concludes that it is a powerful regulatory tool allowing FDA to appropriately ensure that the broad range of moderate risk devices meet the statutory requirement of reasonable assurance of safety and effectiveness. The article examines substantial equivalence review in detail, looking at its historical development, the operative legal framework, the specific decision steps FDA follows to reach a substantial equivalence determination, and the strengths of the system in fostering efficiency, predictability, and adaptability in the premarket review of medical devices. The article rebuts the Institute of Medicine's call to scrap substantial equivalence review, and rebuts another critic's finding that substantial equivalence review results in a disproportionate share of serious recalls. The article suggests that a better public 510(k) database would improve the predictability of substantial equivalence review. The article concludes by calling for targeted reform of a basically sound system rather than wholesale condemnation as critics have suggested.
美国食品和药物管理局(FDA)的510(k)计划基于实质等效审查,是目前需要上市前审查的医疗器械进入市场的主要途径。实质等效性审查受到了很多批评,但本文的结论是,它是一种强大的监管工具,允许FDA适当地确保广泛的中等风险器械满足合理保证安全性和有效性的法定要求。本文详细研究了实质等效性审查,着眼于其历史发展,操作法律框架,FDA为达到实质等效性确定而遵循的具体决策步骤,以及该系统在促进医疗器械上市前审查的效率,可预测性和适应性方面的优势。这篇文章反驳了美国医学研究所(Institute of Medicine)取消实质等同审查的呼吁,并反驳了另一位批评者的发现,即实质等同审查导致严重召回的比例不成比例。本文建议,一个更好的公共510(k)数据库将提高实质等同审查的可预测性。文章最后呼吁对一个基本健全的体系进行有针对性的改革,而不是像批评者建议的那样全盘谴责。
{"title":"Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices.","authors":"Jeffrey K Shapiro","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Food and Drug Administration (FDA)'s 510(k) program based upon substantial equivalence review is by far the dominant pathway to market among medical devices requiring premarket review. Substantial equivalence review has been much criticized, but this article concludes that it is a powerful regulatory tool allowing FDA to appropriately ensure that the broad range of moderate risk devices meet the statutory requirement of reasonable assurance of safety and effectiveness. The article examines substantial equivalence review in detail, looking at its historical development, the operative legal framework, the specific decision steps FDA follows to reach a substantial equivalence determination, and the strengths of the system in fostering efficiency, predictability, and adaptability in the premarket review of medical devices. The article rebuts the Institute of Medicine's call to scrap substantial equivalence review, and rebuts another critic's finding that substantial equivalence review results in a disproportionate share of serious recalls. The article suggests that a better public 510(k) database would improve the predictability of substantial equivalence review. The article concludes by calling for targeted reform of a basically sound system rather than wholesale condemnation as critics have suggested.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 3","pages":"365-97, i"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34706552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The safety of FDA-approved drugs remains a significant concern for patients and medical practitioners. This paper argues that pharmacogenomics can complement pharmacologic class effects in drug-safety management, and their use can be implemented without excessive costs or other impracticalities. Section I of this paper introduces key data, concepts and terms; Section II discusses the phenomenon of pharmacologic class effect as well as the relationship between this phenomenon and the use of pharmacogenomics in both FDA regulation and medical practice; and Section III proposes a means by which simultaneous consideration of pharmacologic class effect and pharmacogenomics can improve the quality of selective risk management.
{"title":"Pharmacogenomics and pharmacologic class effect in drug safety management.","authors":"Mikyung Kim","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The safety of FDA-approved drugs remains a significant concern for patients and medical practitioners. This paper argues that pharmacogenomics can complement pharmacologic class effects in drug-safety management, and their use can be implemented without excessive costs or other impracticalities. Section I of this paper introduces key data, concepts and terms; Section II discusses the phenomenon of pharmacologic class effect as well as the relationship between this phenomenon and the use of pharmacogenomics in both FDA regulation and medical practice; and Section III proposes a means by which simultaneous consideration of pharmacologic class effect and pharmacogenomics can improve the quality of selective risk management.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 4","pages":"603-23, ii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33362271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
As obesity rates continue to rise in the United States, both physicians and patients have demanded more safe and effective drug treatment options. However, following the fen-phen/Redux and sibutramine failures, the FDA has been hesitant to approve any anti-obesity drugs, despite the magnitude of the epidemic. Some have argued that these public embarrassments have led the FDA to overestimate the risks and underestimate the benefits when deciding whether to approve new anti-obesity drugs. On June 27, 2012, the FDA approved Belviq for chronic weight management, making it the first anti-obesity drug approved by the FDA in thirteen years. Less than one month later, the FDA approved Qsymia for the treatment of obesity. Both drugs had been denied FDA approval less than two years earlier. In this paper, I will first review the obesity crisis and discuss the high-profile market withdrawals of fenfluramine, dexfenfluramine, and sibutramine. Second, I will explain the FDA's drug approval process with a focus on the FDA's risk/benefit calculus. Third, I will compare the FDA's risk/benefit analysis for Qsymia and Belviq in 2010 with the agency's risk/benefit analysis in 2012 to determine what caused the agency to grant approval in 2012 while denying it in 2010. Finally, I will analyze what these drug approvals may mean for the future of other anti-obesity drugs.
{"title":"The FDA's risk/benefit calculus in the approvals of Qsymia and Belviq: treating an obesity epidemic while avoiding another fen-phen.","authors":"Lauren M Azebu","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>As obesity rates continue to rise in the United States, both physicians and patients have demanded more safe and effective drug treatment options. However, following the fen-phen/Redux and sibutramine failures, the FDA has been hesitant to approve any anti-obesity drugs, despite the magnitude of the epidemic. Some have argued that these public embarrassments have led the FDA to overestimate the risks and underestimate the benefits when deciding whether to approve new anti-obesity drugs. On June 27, 2012, the FDA approved Belviq for chronic weight management, making it the first anti-obesity drug approved by the FDA in thirteen years. Less than one month later, the FDA approved Qsymia for the treatment of obesity. Both drugs had been denied FDA approval less than two years earlier. In this paper, I will first review the obesity crisis and discuss the high-profile market withdrawals of fenfluramine, dexfenfluramine, and sibutramine. Second, I will explain the FDA's drug approval process with a focus on the FDA's risk/benefit calculus. Third, I will compare the FDA's risk/benefit analysis for Qsymia and Belviq in 2010 with the agency's risk/benefit analysis in 2012 to determine what caused the agency to grant approval in 2012 while denying it in 2010. Finally, I will analyze what these drug approvals may mean for the future of other anti-obesity drugs.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 1","pages":"87-111, ii-iii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32296291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pharmacogenomics is the branch of pharmacology which looks at the influence of genetic variation on drug response, connecting particular genetic markers with the effectiveness or safety of a drug. Pharmacogenomic products promise to improve medical treatment, lower health care costs, and make the new drug pipeline for FDA approval more efficient. In the last fifteen years, the FDA has approved pharmacogenomic drugs to treat a variety of cancers, HIV-AIDS, and coronary artery disease. Yet, progress in the field of pharmacogenomics has lagged behind the optimistic predictions of many researchers and policymakers. A lack of clear regulatory guidance dealing with pharmacogenomic products has been a major barrier to progress in the field. The FDA has, however, made some headway. In a series of guidance documents released between 2005 and 2011, the FDA has clarified much of its policy with respect to the development, approval, and labeling of pharmacogenomic products. Despite these efforts, many regulatory questions remain unanswered. This paper highlights a number of these regulatory gaps and provides recommendations to address them in a way which encourages increased development and clinical uptake of pharmacogenomic products.
{"title":"Pharmacogenomics: history, barriers, and regulatory solutions.","authors":"Sarah Blankstein","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Pharmacogenomics is the branch of pharmacology which looks at the influence of genetic variation on drug response, connecting particular genetic markers with the effectiveness or safety of a drug. Pharmacogenomic products promise to improve medical treatment, lower health care costs, and make the new drug pipeline for FDA approval more efficient. In the last fifteen years, the FDA has approved pharmacogenomic drugs to treat a variety of cancers, HIV-AIDS, and coronary artery disease. Yet, progress in the field of pharmacogenomics has lagged behind the optimistic predictions of many researchers and policymakers. A lack of clear regulatory guidance dealing with pharmacogenomic products has been a major barrier to progress in the field. The FDA has, however, made some headway. In a series of guidance documents released between 2005 and 2011, the FDA has clarified much of its policy with respect to the development, approval, and labeling of pharmacogenomic products. Despite these efforts, many regulatory questions remain unanswered. This paper highlights a number of these regulatory gaps and provides recommendations to address them in a way which encourages increased development and clinical uptake of pharmacogenomic products.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 2","pages":"273-314, ii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32618692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Historically, courts have afforded patent holders broad discretion to choose where to sue Abbreviated New Drug Application (ANDA) filers. Patent holders' assertions of jurisdiction have typically rested on general personal jurisdiction theories, frequently based on an ANDA filers' conduct within the state, including sales, submission to previous lawsuits, and assignments of agents to accept service of process. Consequently, manyANDA cases have taken place in the Districts of Delaware or New Jersey, or where the patent holder is incorporated, despite the ANDA filer's incorporation in a different state. However, since the Supreme Court's decision in Daimler AG v. Bauman, options for the exercise of personal jurisdiction over ANDA filers have narrowed. This article examines what Daimler means for future ANDA filers, and highlights how many patent holders have failed to take this change into account.
{"title":"Who to Sue and Where in ANDA Litigation: Personal Jurisdiction Post-Daimler.","authors":"H Weisblatt, Claire Frezza","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Historically, courts have afforded patent holders broad discretion to choose where to sue Abbreviated New Drug Application (ANDA) filers. Patent holders' assertions of jurisdiction have typically rested on general personal jurisdiction theories, frequently based on an ANDA filers' conduct within the state, including sales, submission to previous lawsuits, and assignments of agents to accept service of process. Consequently, manyANDA cases have taken place in the Districts of Delaware or New Jersey, or where the patent holder is incorporated, despite the ANDA filer's incorporation in a different state. However, since the Supreme Court's decision in Daimler AG v. Bauman, options for the exercise of personal jurisdiction over ANDA filers have narrowed. This article examines what Daimler means for future ANDA filers, and highlights how many patent holders have failed to take this change into account.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 3","pages":"351-64, i"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34706551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}