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Inaugural Eric M. Blumberg Memorial Lecture. 埃里克-布伦贝格（Eric M. Blumberg）首届纪念讲座。
IF 0.3 4区 医学
Food and drug law journal Pub Date : 2014-01-01
Annamarie Kempic
{"title":"Inaugural Eric M. Blumberg Memorial Lecture.","authors":"Annamarie Kempic","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 2","pages":"137-42"},"PeriodicalIF":0.3,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32618688","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}
引用次数: 0
Legal considerations for social media marketing by pharmaceutical industry. 医药行业社会化媒体营销的法律考量。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2014-01-01
Y Tony Yang, Brian Chen
{"title":"Legal considerations for social media marketing by pharmaceutical industry.","authors":"Y Tony Yang,&nbsp;Brian Chen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 1","pages":"39-51, ii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32296289","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}
引用次数: 0
We really need to talk: adapting FDA processes to rapid change. 我们真的需要谈谈:调整FDA流程以适应快速变化。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2013-01-01
Sara Lykken
{"title":"We really need to talk: adapting FDA processes to rapid change.","authors":"Sara Lykken","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"68 4","pages":"357-99, i"},"PeriodicalIF":0.2,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32140992","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}
引用次数: 0
Credible deterrence: FDA and the Park Doctrine in the 21st century. 可信威慑:21世纪的FDA和公园主义。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2013-01-01
Patrick O'Leary
{"title":"Credible deterrence: FDA and the Park Doctrine in the 21st century.","authors":"Patrick O'Leary","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>One of FDA's most powerful enforcement tools is strict liability criminal prosecution of corporate officers under the Park Doctrine. Recent comments by high-ranking FDA officials about using this power more aggressively and recent cases apparently making good on this promise have spurred commentators to call for the doctrine's demise. Critics argue that strict liability for corporate officers violates fundamental notions of fairness and the appropriate relationship between guilt and liability in criminal law. As a response to these critics, this article argues that the Park Doctrine continues to serve a valuable purpose in deterring conduct that endangers the public health and that structural, political, and practical limitations on FDA's use of Park prosecutions have been, and will continue to be, effective protections against the abuses critics fear. This article proposes a model for understanding why and how FDA uses its prosecutorial powers and assesses a sample of recent high-profile prosecutions under this model to argue that the modern \"escalation\" of Park prosecutions is in fact a continuation of FDA's historical policy.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"68 2","pages":"137-88, i"},"PeriodicalIF":0.2,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32184828","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}
引用次数: 0
Chinese regulation of off-label use of drugs. 中国对超说明书用药的监管。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2013-01-01
Feng Ma, Nan Lou
{"title":"Chinese regulation of off-label use of drugs.","authors":"Feng Ma,&nbsp;Nan Lou","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs. As in the United States, the off-label prescribing of drugs is not prohibited in China if there is a sound scientific basis. Physicians are allowed to prescribe off-label drugs based on their medical judgment if they follow certain requirements. There is some constraint on the right to prescribe by the imposition of malpractice liability if patients are harmed from improper off-label prescribing. However, damages awarded to successful plaintiffs are usually insignificant compared to malpractice damage awards in the U.S. Advertisement of off-label use is prohibited in China. All drug advertisements in China are subject to pre-approval, and must be based on information included in the approved package insert. However, the term \"advertisement\" is poorly defined. As a result, non-advertisement promotion of drugs for on-label or off-label use exist in a unregulated gray area. To better address the problem of inappropriate off-label promotion and use, China should (i) regulate both drug advertisements and non-advertisement promotion under a standard requiring off-label use to have a sound scientific basis, (ii) introduce harsher regulatory penalties, and (iii) increase compensation available for victims of medical malpractice. Such reform would not only discourage improper off-label use by introducing penalties (or increasing existing penalties) for improper promotion, but would also provide reasonable compensation for victims harmed by off-label use.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"68 2","pages":"189-200, ii"},"PeriodicalIF":0.2,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32185333","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}
引用次数: 0
Your business in court and at Federal agencies: 2011-2012. 2011-2012年，你在法庭和联邦机构的业务。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2013-01-01
John B Reiss, Dawn Crowder, Brittany McCabe, Marisa DeFeo, Marta Rifin, Meghan Talbot
{"title":"Your business in court and at Federal agencies: 2011-2012.","authors":"John B Reiss,&nbsp;Dawn Crowder,&nbsp;Brittany McCabe,&nbsp;Marisa DeFeo,&nbsp;Marta Rifin,&nbsp;Meghan Talbot","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"68 1","pages":"1-51, i"},"PeriodicalIF":0.2,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32185355","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}
引用次数: 0
Does Sackett foreshadow the end of non-reviewability for FDA warning letters? Sackett是否预示着FDA警告信不可复审的终结?
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2013-01-01
Katelyn DeRuyter
{"title":"Does Sackett foreshadow the end of non-reviewability for FDA warning letters?","authors":"Katelyn DeRuyter","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedure Act (APA). The Supreme Court's analysis in Sackett v. EPA suggests the legal tides might be shifting. In Sackett, the Court held that an Environmental Protection Agency (EPA) compliance order was considered final agency action subject to judicial review under the APA. While there are differences between compliance orders and warning letters, both inform regulated parties of non-compliance with federal law and are highly valued measures of inducing \"voluntary compliance.\" Sackett should provide precedent for future litigation over judicial reviewability of warning letters.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"68 3","pages":"241-58, i"},"PeriodicalIF":0.2,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32186061","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}
引用次数: 0
America, you are digging your grave with your spoon--should the FDA tell you that on food labels? 美国，你是在用勺子自掘坟墓——食品药品监督管理局应该在食品标签上告诉你吗?
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2013-01-01
Melissa M Card
{"title":"America, you are digging your grave with your spoon--should the FDA tell you that on food labels?","authors":"Melissa M Card","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"68 3","pages":"309-27, ii-iii"},"PeriodicalIF":0.2,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32186064","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}
引用次数: 0
United States v. Caronia: The increasing strength of commercial free speech and potential new emphasis on classifying off-label promotion as "false and misleading". 美国诉卡罗尼亚:商业言论自由的力量日益增强，并可能重新强调将标签外促销分类为“虚假和误导”。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2013-01-01
Marc J Scheineson, Guillermo Cuevas
{"title":"United States v. Caronia: The increasing strength of commercial free speech and potential new emphasis on classifying off-label promotion as \"false and misleading\".","authors":"Marc J Scheineson,&nbsp;Guillermo Cuevas","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The authority of the United States Food and Drug Administration (FDA) to prohibit off-label promotion of drug products suffered another serious setback in United States v. Caronia. Viewing a legal system where physicians can prescribe prescription pharmaceuticals for unapproved uses legally in their practice of medicine, the Federal appeals court affirmed the commercial free speech rights of manufacturers to use truthful, non-misleading speech about lawfully marketed products. As a result of this case, and others upon which the decision is based, FDA is likely to challenge manufacturer promotion more carefully, and only if it can demonstrate that claims are not truthful, but are false or misleading, or otherwise deprive the prescriber of adequate directions for use.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"68 2","pages":"201-16, iii"},"PeriodicalIF":0.2,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32185336","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}
引用次数: 0
Beyond cheeseburgers: the impact of commonsense consumption acts on future obesity-related lawsuits. 超越芝士汉堡:常识性消费行为对未来肥胖相关诉讼的影响。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2013-01-01
Cara L Wilking, Richard A Daynard
{"title":"Beyond cheeseburgers: the impact of commonsense consumption acts on future obesity-related lawsuits.","authors":"Cara L Wilking,&nbsp;Richard A Daynard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Since 2004, 25 states have passed Commonsense Consumption Acts (CCAs) to shield the food industry from civil liability for claims arising from obesity-related health harms. These laws continue to be introduced. CCAs have generally been discussed in terms of \"tort reform.\" For this article, we conducted a systematic analysis of the content of all 25 state laws and found that the potential impact of CCAs goes well beyond obesity-related tort reform to limits on state Attorney General (AGs) authority and significant reforms to future statutory consumer protection claims by AGs, individuals and classes of consumers. Moreover, every CCA state had pre-existing legal protections against frivolous litigation-greatly undercutting arguments made by CCA proponents.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"68 3","pages":"229-39, i"},"PeriodicalIF":0.2,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32186060","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}
引用次数: 0
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