Recent years have seen mounting calls to vest agencies with litigation gatekeeper authority across a range of regulatory areas, including civil rights, antitrust, and financial and securities regulation. Agencies, it is said, can rationalize litigation regimes through the power to oversee, control, and even terminate private enforcement efforts. Yet there exists strikingly little theory or evidence on how such agency gatekeeper authority might work in practice. This paper aims to fill that gap by offering the first large-scale quantitative study of an often-invoked but little-studied example of a private enforcement regime incorporating such authority: the qui tam regime established by the False Claims Act (“FCA”). The FCA’s qui tam provisions empower private persons, dubbed “relators,” to sue private parties alleging fraud against the United States and earn a bounty equal to a portion of any proceeds returned to the federal treasury. The FCA also grants the United States Department of Justice (“DOJ”) substantial oversight authority, including the ability to intervene into qui tam lawsuits, thus taking primary control over the litigation, or dismiss lawsuits out from under private relators entirely. Using an original data set encompassing some 4,000 qui tam lawsuits filed between 1986 and 2008, I ask a deceptively simple question: What drives DOJ intervention decisions? My analysis recovers a number of political and non-political correlates of DOJ intervention decision-making, provides an empirical baseline against which to measure proposed FCA amendments as well as proliferating calls to export its unique public-private enforcement structure to other regulatory areas, and suggests the need to reorient scholarly debate around the possibilities and limits of private enforcement of public law.
{"title":"Agencies as Litigation Gatekeepers: An Empirical Analysis of DOJ Intervention Under the Qui Tam Provisions of the False Claims Act","authors":"D. Engstrom","doi":"10.2139/ssrn.1882181","DOIUrl":"https://doi.org/10.2139/ssrn.1882181","url":null,"abstract":"Recent years have seen mounting calls to vest agencies with litigation gatekeeper authority across a range of regulatory areas, including civil rights, antitrust, and financial and securities regulation. Agencies, it is said, can rationalize litigation regimes through the power to oversee, control, and even terminate private enforcement efforts. Yet there exists strikingly little theory or evidence on how such agency gatekeeper authority might work in practice. This paper aims to fill that gap by offering the first large-scale quantitative study of an often-invoked but little-studied example of a private enforcement regime incorporating such authority: the qui tam regime established by the False Claims Act (“FCA”). The FCA’s qui tam provisions empower private persons, dubbed “relators,” to sue private parties alleging fraud against the United States and earn a bounty equal to a portion of any proceeds returned to the federal treasury. The FCA also grants the United States Department of Justice (“DOJ”) substantial oversight authority, including the ability to intervene into qui tam lawsuits, thus taking primary control over the litigation, or dismiss lawsuits out from under private relators entirely. Using an original data set encompassing some 4,000 qui tam lawsuits filed between 1986 and 2008, I ask a deceptively simple question: What drives DOJ intervention decisions? My analysis recovers a number of political and non-political correlates of DOJ intervention decision-making, provides an empirical baseline against which to measure proposed FCA amendments as well as proliferating calls to export its unique public-private enforcement structure to other regulatory areas, and suggests the need to reorient scholarly debate around the possibilities and limits of private enforcement of public law.","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"74 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2011-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85793764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care.Traditionally, inventors of medical products such as drugs and devices obtain patent protection at the United States Patent and Trademark Office (USPTO) for a twenty-year exclusive term and simultaneously must seek FDA approval to market their invention and for a trademark for their brand name.Because of the complicated and thorough approval process the FDA conducts, it is often expensive and time-consuming for the initial innovator to bring a drug to market. Likewise, it is often prohibitively expensive for a generic follow-on company to bring an analogue to market, after patent protection has expired, through duplicative and costly reapproval of the innovator drug, and it would be unethical to subject further human subjects to unneeded clinical trials.To deal with these problems, in 1984 Congress enacted a law called the Price, Competition, and Patent Term Restoration Act, which is commonly referred to as the Hatch–Waxman Act. The Act allows generic follow-on drugs to seek accelerated approval by the FDA. In exchange, the law grants limited data exclusivity — and hence, often de facto market exclusivity — for the original brand-name innovator. The Act utilizes a preexisting compilation of all relevant drugs and their clinical indications, the Orange Book, to list generic analogues. Most importantly, Hatch–Waxman allows generic drug manufacturers to use the same FDA approval data as the brand-name manufacturers had in an abbreviated approval application (thus eliminating the need for duplicative human trials and reducing cost for generic manufacturers). The result has been a decrease in the cost of prescription drugs due to increased price competition after the expiration of the original drug’s patent term.By formulating the Hatch–Waxman Act broadly, Congress has given the FDA wide flexibility to regulate. It has mandated the use of guidance documents, a less costly and time-consuming form of regulating than formal or even informal rulemaking. This guidance mandate has the advantage of increased flexibility and a faster turnaround time than traditional notice-and-comment rulemaking. Nevertheless, if the FDA does not use that flexibility judiciously, the Biosimilars Act may not achieve actual reductions in the cost of prescription biological drugs or significantly affect the cost of health care.Part I of this Comment discusses the Hatch–Waxma
{"title":"The Illusion of Interchangeability: The Benefits and Dangers of Guidance-Plus Rulemaking in the FDA's Biosimilar Approval Process","authors":"Jonathan R. K. Stroud","doi":"10.2139/SSRN.2047458","DOIUrl":"https://doi.org/10.2139/SSRN.2047458","url":null,"abstract":"On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care.Traditionally, inventors of medical products such as drugs and devices obtain patent protection at the United States Patent and Trademark Office (USPTO) for a twenty-year exclusive term and simultaneously must seek FDA approval to market their invention and for a trademark for their brand name.Because of the complicated and thorough approval process the FDA conducts, it is often expensive and time-consuming for the initial innovator to bring a drug to market. Likewise, it is often prohibitively expensive for a generic follow-on company to bring an analogue to market, after patent protection has expired, through duplicative and costly reapproval of the innovator drug, and it would be unethical to subject further human subjects to unneeded clinical trials.To deal with these problems, in 1984 Congress enacted a law called the Price, Competition, and Patent Term Restoration Act, which is commonly referred to as the Hatch–Waxman Act. The Act allows generic follow-on drugs to seek accelerated approval by the FDA. In exchange, the law grants limited data exclusivity — and hence, often de facto market exclusivity — for the original brand-name innovator. The Act utilizes a preexisting compilation of all relevant drugs and their clinical indications, the Orange Book, to list generic analogues. Most importantly, Hatch–Waxman allows generic drug manufacturers to use the same FDA approval data as the brand-name manufacturers had in an abbreviated approval application (thus eliminating the need for duplicative human trials and reducing cost for generic manufacturers). The result has been a decrease in the cost of prescription drugs due to increased price competition after the expiration of the original drug’s patent term.By formulating the Hatch–Waxman Act broadly, Congress has given the FDA wide flexibility to regulate. It has mandated the use of guidance documents, a less costly and time-consuming form of regulating than formal or even informal rulemaking. This guidance mandate has the advantage of increased flexibility and a faster turnaround time than traditional notice-and-comment rulemaking. Nevertheless, if the FDA does not use that flexibility judiciously, the Biosimilars Act may not achieve actual reductions in the cost of prescription biological drugs or significantly affect the cost of health care.Part I of this Comment discusses the Hatch–Waxma","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"63 1","pages":"599"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2139/SSRN.2047458","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67881686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-03-02DOI: 10.5040/9781472560759.ch-008
S. Halliday, C. Scott
In recent years we have seen rapid change in the organisation of public management. Various developments, sometimes captured in the notion of the ‘new public management’, have significantly altered the character of public administration. This presents quite a challenge for theorists of administrative justice. The values and processes which infuse new public management sit in some tension with traditional conceptions of administrative justice, particularly within legal theory. To what extent should the concept be extended to embrace these real-world developments? Further, is there more to be said about administrative justice than is not captured by existing theory, even including a focus on new public management? These questions form the background to this article in which we develop a typology of administrative justice – an analytical framework which captures the variations in how ‘administrative justice’ might be conceived. Our analysis re-works the typologies of Mashaw, Adler and Kagan and places them in a wider framework developed from grid-group cultural theory. The analysis also draws attention to conceptions of administrative justice not previously discussed in the literature: decision-making by lottery, and decision-making by consensus.
{"title":"A Cultural Analysis of Administrative Justice","authors":"S. Halliday, C. Scott","doi":"10.5040/9781472560759.ch-008","DOIUrl":"https://doi.org/10.5040/9781472560759.ch-008","url":null,"abstract":"In recent years we have seen rapid change in the organisation of public management. Various developments, sometimes captured in the notion of the ‘new public management’, have significantly altered the character of public administration. This presents quite a challenge for theorists of administrative justice. The values and processes which infuse new public management sit in some tension with traditional conceptions of administrative justice, particularly within legal theory. To what extent should the concept be extended to embrace these real-world developments? Further, is there more to be said about administrative justice than is not captured by existing theory, even including a focus on new public management? These questions form the background to this article in which we develop a typology of administrative justice – an analytical framework which captures the variations in how ‘administrative justice’ might be conceived. Our analysis re-works the typologies of Mashaw, Adler and Kagan and places them in a wider framework developed from grid-group cultural theory. The analysis also draws attention to conceptions of administrative justice not previously discussed in the literature: decision-making by lottery, and decision-making by consensus.","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2009-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89893819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Legal scholars have long recognized the importance of the modern administrative state, focusing intently both on the substance of regulatory law and the process of administrative law. Neither focus, however, recognizes the importance of institutional design and institutional processes as determinants of the nature and shape of administrative regulation. The era of neglect towards institutional analysis by both scholars and policymakers may well be on its last legs, as it is increasingly clear that the institutional processes used by regulatory agencies - including when to act by rulemaking as opposed to by adjudication, how to engage the public, and how to collect and share data relevant to policymaking - greatly shape the substantive outcomes of important regulatory proceedings. The emerging question will be how best to study institutional process and create a new direction for administrative law scholarship. The Federal Communications Commission (FCC) represents an ideal case study to underscore the importance of institutional analysis. Over the last fifty years, the agency has confronted a regular set of criticisms about its reliance on ex parte communications, its lack of data-driven decision-making, and its tendency to act in an ad hoc manner. Nonetheless, the importance of reforming the agency has not risen to the top of the scholarly or public agenda - until recently. In the wake of a series of high-profile criticisms of how the agency operates, the question is now finally shifting to how - and not whether - to reform that agency's institutional processes. This Article highlights the importance of asking that question, explaining how the FCC operates in dysfunctional ways, how it can be reformed, and why this case study highlights an important new frontier for administrative law scholarship.
{"title":"Institutional Design, FCC Reform, and the Hidden Side of the Administrative State","authors":"P. Weiser","doi":"10.2139/SSRN.1336820","DOIUrl":"https://doi.org/10.2139/SSRN.1336820","url":null,"abstract":"Legal scholars have long recognized the importance of the modern administrative state, focusing intently both on the substance of regulatory law and the process of administrative law. Neither focus, however, recognizes the importance of institutional design and institutional processes as determinants of the nature and shape of administrative regulation. The era of neglect towards institutional analysis by both scholars and policymakers may well be on its last legs, as it is increasingly clear that the institutional processes used by regulatory agencies - including when to act by rulemaking as opposed to by adjudication, how to engage the public, and how to collect and share data relevant to policymaking - greatly shape the substantive outcomes of important regulatory proceedings. The emerging question will be how best to study institutional process and create a new direction for administrative law scholarship. The Federal Communications Commission (FCC) represents an ideal case study to underscore the importance of institutional analysis. Over the last fifty years, the agency has confronted a regular set of criticisms about its reliance on ex parte communications, its lack of data-driven decision-making, and its tendency to act in an ad hoc manner. Nonetheless, the importance of reforming the agency has not risen to the top of the scholarly or public agenda - until recently. In the wake of a series of high-profile criticisms of how the agency operates, the question is now finally shifting to how - and not whether - to reform that agency's institutional processes. This Article highlights the importance of asking that question, explaining how the FCC operates in dysfunctional ways, how it can be reformed, and why this case study highlights an important new frontier for administrative law scholarship.","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2009-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68165247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
شش سیگما[i]و ناب[ii] دو رویکرد قدرتمند برای بهبود کارآیی و کیفیت فرآیند هستند که هر کدام شامل مجموعهای از ابزارها، مبانی و اصول خاص بوده و سیستمهای مدیریتی توانمندی برای ارائه محصولات و خدمات کیفی و مبتنی بر خواست مشتری و مخاطب از طریق حذف خطاهای فرآیندها و اتلافها و ارزش آفرینی در سازمان میباشند. مقاله حاضر براساس مطالعات کتابخانهای و بررسی تحلیلی محتوای مقاله ها و کتب فارسی و انگلیسی با هدف تبیین و تشریح مبانی نظری و اصول این دو رویکرد مدیریتی و بومی سازی و پیوند آنها به آموزش و پرورش، تدوین گردیده تا بستر مناسبی را جهت کاربرد آنها در مدیریت نظام آموزشی فراهم سازد. بدون تردید، با به کارگیری ابزارها، اصول و روش های مربوط به شش سیگما و ناب در آموزش و پرورش در جهت کاهش خطای فرآیندهای کاری و افزایش قابلیت آنها و همچنین ارزش آفرینی و حذف اتلافها شاهد تحولات عظیمی در نظام آموزشی و کسب نتایج مطلوب و بیعیب و نقص و تحقق بهینه و کیفی اهداف آموزش و پرورش خواهیم بود. [i] Six Sigma [ii] Lean
{"title":"بررسی اجرای فصل دهم قانون مدیریت خدمات کشوری در آموزش و پرورش","authors":"مهدی زارع بهرام آبادی, اکرم پوزاد, سمیه سلیمانی, سعید جعفری","doi":"10.29252/QJAL.7.20.37","DOIUrl":"https://doi.org/10.29252/QJAL.7.20.37","url":null,"abstract":"شش سیگما[i]و ناب[ii] دو رویکرد قدرتمند برای بهبود کارآیی و کیفیت فرآیند هستند که هر کدام شامل مجموعهای از ابزارها، مبانی و اصول خاص بوده و سیستمهای مدیریتی توانمندی برای ارائه محصولات و خدمات کیفی و مبتنی بر خواست مشتری و مخاطب از طریق حذف خطاهای فرآیندها و اتلافها و ارزش آفرینی در سازمان میباشند. مقاله حاضر براساس مطالعات کتابخانهای و بررسی تحلیلی محتوای مقاله ها و کتب فارسی و انگلیسی با هدف تبیین و تشریح مبانی نظری و اصول این دو رویکرد مدیریتی و بومی سازی و پیوند آنها به آموزش و پرورش، تدوین گردیده تا بستر مناسبی را جهت کاربرد آنها در مدیریت نظام آموزشی فراهم سازد. بدون تردید، با به کارگیری ابزارها، اصول و روش های مربوط به شش سیگما و ناب در آموزش و پرورش در جهت کاهش خطای فرآیندهای کاری و افزایش قابلیت آنها و همچنین ارزش آفرینی و حذف اتلافها شاهد تحولات عظیمی در نظام آموزشی و کسب نتایج مطلوب و بیعیب و نقص و تحقق بهینه و کیفی اهداف آموزش و پرورش خواهیم بود. \u0000 \u0000 \u0000[i] Six Sigma \u0000 \u0000 \u0000 \u0000[ii] Lean","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"79 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2008-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85836556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The EC and it's Member States struggle to draw the line between markets and public interests. Traditionally, these two are contrasted, most prominently by the continental Member States and followed by a conclusion that public interests require public governance. Some of this public governance takes the form of a public law framework within which self-regulation by the members of a profession occurs. We also see a more subtle version of self-regulation, whereby regulators are so dependent on specific information from the professions concerned, that they effectively become captive regulators. In those circumstances, the degree to which the public interest, rather than the interest of the professions concerned, is actually served may be doubted.This holds true even more where legislators, both at the EC and the Member State level, are moving the line between markets and public interests towards the market side. It is uniformly recognised that public governance is not the blanket solution for market failures and the introduction of market mechanisms may actually increase consumer welfare. The contrast between public interests and markets may therefore also be rephrased into a citizens versus consumers antithesis. EC (competition) law plays a prominent role in this debate in that it requires member state regulators to rethink how and to what extent their actions serve the public interest. This role of EC (competition) law requires a fundamental rethinking of the market (consumer) and public interest (citizen) antithesis. The hypothesis central to this paper is that EC (competition) law can serve as a democratic instrument to increase legitimacy whilst refining the line between markets and public interests.
{"title":"The Constitutionality of Competition - EC Internal Market Law and the Fine Line between Markets, Public Interests and (Self-)Regulation in a Changing Constitutional Setting","authors":"H. Vedder","doi":"10.2139/ssrn.1282035","DOIUrl":"https://doi.org/10.2139/ssrn.1282035","url":null,"abstract":"The EC and it's Member States struggle to draw the line between markets and public interests. Traditionally, these two are contrasted, most prominently by the continental Member States and followed by a conclusion that public interests require public governance. Some of this public governance takes the form of a public law framework within which self-regulation by the members of a profession occurs. We also see a more subtle version of self-regulation, whereby regulators are so dependent on specific information from the professions concerned, that they effectively become captive regulators. In those circumstances, the degree to which the public interest, rather than the interest of the professions concerned, is actually served may be doubted.This holds true even more where legislators, both at the EC and the Member State level, are moving the line between markets and public interests towards the market side. It is uniformly recognised that public governance is not the blanket solution for market failures and the introduction of market mechanisms may actually increase consumer welfare. The contrast between public interests and markets may therefore also be rephrased into a citizens versus consumers antithesis. EC (competition) law plays a prominent role in this debate in that it requires member state regulators to rethink how and to what extent their actions serve the public interest. This role of EC (competition) law requires a fundamental rethinking of the market (consumer) and public interest (citizen) antithesis. The hypothesis central to this paper is that EC (competition) law can serve as a democratic instrument to increase legitimacy whilst refining the line between markets and public interests.","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2008-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79285070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What is collective wisdom, and how can institutions be designed to generate and exploit it? This essay argues for a reductionist conception of collective wisdom as collective epistemic accuracy, and cashes out that conception at the level of institutional design. Assuming that the social goal is to maximize the epistemic quality of the laws, I argue for a shift of constitutional lawmaking authority from courts to Congress and the executive, for the appointment of nonlawyers to the Supreme Court, and for an expansion of Congress' membership. I also outline the trade offs between epistemic and nonepistemic values, such as the costs of decision making, the aggregation of preferences, and the perceived legitimacy of the legal system.
{"title":"Collective Wisdom and Institutional Design","authors":"Adrian Vermeule","doi":"10.2139/ssrn.1259155","DOIUrl":"https://doi.org/10.2139/ssrn.1259155","url":null,"abstract":"What is collective wisdom, and how can institutions be designed to generate and exploit it? This essay argues for a reductionist conception of collective wisdom as collective epistemic accuracy, and cashes out that conception at the level of institutional design. Assuming that the social goal is to maximize the epistemic quality of the laws, I argue for a shift of constitutional lawmaking authority from courts to Congress and the executive, for the appointment of nonlawyers to the Supreme Court, and for an expansion of Congress' membership. I also outline the trade offs between epistemic and nonepistemic values, such as the costs of decision making, the aggregation of preferences, and the perceived legitimacy of the legal system.","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2008-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79066332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In an effort to improve efficiency, several administrative agencies, including the Food and Drug Administration, have adopted a procedure known as direct final rulemaking (DFR). Some academics have debated whether DFR violates the Administrative Procedure Act, but none have studied how DFR has functioned in practice. This paper, which examines the first decade of DFR at the FDA, is the first of this kind. The results are surprising, and suggest DFR deserves more study than it has received. Intended for noncontroversial rules that are expected to receive no significant comments in a notice-and-comment rulemaking, FDA has often used direct final rulemaking for the opposite: regulations that may be expected to be controversial. Far from generating few comments, forty percent of DFRs have had to be withdrawn due to significant opposition. These findings suggest greater limits be placed on the use of direct final rulemaking and that its legality be re-evaluated in light of how the procedure is actually used.
{"title":"Direct Final Rulemaking in the FDA: Lessons from the First Decade","authors":"M. Kolber","doi":"10.2139/SSRN.1121550","DOIUrl":"https://doi.org/10.2139/SSRN.1121550","url":null,"abstract":"In an effort to improve efficiency, several administrative agencies, including the Food and Drug Administration, have adopted a procedure known as direct final rulemaking (DFR). Some academics have debated whether DFR violates the Administrative Procedure Act, but none have studied how DFR has functioned in practice. This paper, which examines the first decade of DFR at the FDA, is the first of this kind. The results are surprising, and suggest DFR deserves more study than it has received. Intended for noncontroversial rules that are expected to receive no significant comments in a notice-and-comment rulemaking, FDA has often used direct final rulemaking for the opposite: regulations that may be expected to be controversial. Far from generating few comments, forty percent of DFRs have had to be withdrawn due to significant opposition. These findings suggest greater limits be placed on the use of direct final rulemaking and that its legality be re-evaluated in light of how the procedure is actually used.","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"23 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2008-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84017561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In a system of divided power, public sector agencies are an important front in the day-to-day battle for political supremacy between the executive and the legislature. The executive's key agents in this conflict are his appointees, who are observed playing two broad roles: allies, where they work to help Congress implement policy and adversaries, where they fight with Congress to shift policy strongly in the executive's direction. This paper studies how these two roles arise and what implications they have for the interaction of Congress and the executive in administrative policymaking. Thereby, it highlights how intrinsically motivated bureaucrats combined with hierarchical control affect the ability of the political principals to control the execution of policy. Furthermore, I explore how this interaction shifts under alternative institutional forms, and how it leads appointees to "marry the natives." The model makes several predictions concerning Congressional oversight of bureaucratic agencies. These predictions are broadly supported by an empirical analysis of audit reports released by the Government Accountability Office.
{"title":"Allies and Adversaries: The Roles of Appointees in Administrative Policymaking under Separation of Powers","authors":"Patrick L. Warren","doi":"10.2139/ssrn.1144112","DOIUrl":"https://doi.org/10.2139/ssrn.1144112","url":null,"abstract":"In a system of divided power, public sector agencies are an important front in the day-to-day battle for political supremacy between the executive and the legislature. The executive's key agents in this conflict are his appointees, who are observed playing two broad roles: allies, where they work to help Congress implement policy and adversaries, where they fight with Congress to shift policy strongly in the executive's direction. This paper studies how these two roles arise and what implications they have for the interaction of Congress and the executive in administrative policymaking. Thereby, it highlights how intrinsically motivated bureaucrats combined with hierarchical control affect the ability of the political principals to control the execution of policy. Furthermore, I explore how this interaction shifts under alternative institutional forms, and how it leads appointees to \"marry the natives.\" The model makes several predictions concerning Congressional oversight of bureaucratic agencies. These predictions are broadly supported by an empirical analysis of audit reports released by the Government Accountability Office.","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2008-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87368594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This paper examines legislative review of administrative rule-making in Oregon. It analyzes a 2000 proposed amendment to the Oregon Constitution, defeated by the voters after publication of this analysis, that called for enhanced legislative review of administrative rules. It also analyzes the probable impact on the Oregon land use system had the proposed amendment passed. The paper argues that Oregon's current system provides adequate legislative oversight of administrative rule-making.
{"title":"Creating Accountability or Wreaking Havoc? Legislative Review of Administrative Rulemaking Under Measure 2","authors":"Susan L. Smith","doi":"10.2139/ssrn.3392120","DOIUrl":"https://doi.org/10.2139/ssrn.3392120","url":null,"abstract":"This paper examines legislative review of administrative rule-making in Oregon. It analyzes a 2000 proposed amendment to the Oregon Constitution, defeated by the voters after publication of this analysis, that called for enhanced legislative review of administrative rules. It also analyzes the probable impact on the Oregon land use system had the proposed amendment passed. The paper argues that Oregon's current system provides adequate legislative oversight of administrative rule-making.","PeriodicalId":51730,"journal":{"name":"Administrative Law Review","volume":"61 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2008-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81121087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"法学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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