Loyola University Chicago, School of Law: LAW eCommons
Not a member yet
4877 research outputs found
Sort by
The Space Between Grand Optimism and Grim Determination: Finding a Pathway Forward in International Climate Change Law
Full text link
Three Framing of Faster at the FDA and the Federal Right to Try
No full textIn May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug status to postmarket studies and surveillance. I categorize these mechanisms into three areas: expansion, acceleration, and extension. The federal right to try can be characterized as an expansion, expanding patient access to investigational new drugs as an alternative mechanism to the FDA’s long-standing expanded access program. As the Senate notes, the RTT Act “does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right” and “is consistent with and will act as an alternative pathway alongside existing expanded access policies of the Food and Drug Administration.”
This article positions the new RTT in proper context and explores additional FDA mechanisms that serve to speed up patient access. In Part I, this article will first discuss the content and scope of the RTT legislation, as well as the reasoning for the support and opposition for the legislation. The legislation is only four pages long, as enacted, and introduces a concise procedure for requests for access to investigational drugs. The article will next examine FDA mechanisms for expansion in Part II, comparing the RTT with the current expanded access program at the FDA. Part II will explore two mechanisms of expansion at the FDA: expanded access for patients to investigational drugs and devices (the “expanded access” program) and expanded input from patients about experiences with drugs and devices under review at the FDA ( patient experience data). This expansion of patient input was initiated and implemented within the FDA but further directed by provisions within the 21st Century Cures Act.
Part III will analyze several mechanisms of accelerated review and approval at the FDA, including FastTrack status, priority review, accelerated approval, Orphan Drug status, and Breakthrough designation of promising therapeutics. The collection of hastened mechanisms of review and approval are poorly understood and have led to confusion and misunderstanding by physicians and patients alike. They also alter the foundational new drug approval framework originally set forth by Congress in the Kefauver-Harris Drug Amendments enacted in 1962, which strengthened the drug approval process to include not only premarket safety review but also substantial evidence of efficacy demonstrated through “adequate and well-controlled” clinical trials. Recent empirical scholarship informs this Part, revealing that the growing array of statutory mechanisms to speed up clinical trials, review, and approval are cutting away at long-standing protections afforded by robust measures of safety and efficacy. Part IV will then discuss extension at the FDA, particularly the extension of evidence gathering in post-market clinical trials to support showings of safety and efficacy. The article concludes with several reflections on the relationship of the federal RTT to these FDA mechanisms of faster access, as well as potential implications of expansion, acceleration, and extension on patient safety, patent protections, and drug costs
The Incoherent Justification for Naked Restraints of Competition: What the Dental Self-Regulation Cases Tell Us About the Cavities in Antitrust Law
Full text linkThere is an inescapable inconsistency between the general rule that naked (cartelistic) restraints of competition are per se illegal and the treatment of such restraints when engaged in by self-regulatory professional organizations, standard setting organizations, and various private organizations that regulate competition in variety of athletic and other activities. Most observers believe that some of that cartelistic regulation may be not only socially and economically desirable but also necessary to serve the public interest. The judicial effort to explain when cartels or other naked restraints on competition within or between such groups and others are lawful and when they are not has floundered on the lack of specificity of the “rule of reason” which invites linking any justification for a restraint to some ambiguous assertion of “reasonableness.” The inevitable implication is that any cartel could be lawful if it were reasonable and served some “procompetitive,” “consumer welfare,” or other “public interest” goal. This Article contends that this approach is wrong. Instead, what courts are in fact doing is preempting certain kinds of restraints from antitrust law review, although this is evident only by implication. This Article applies the Carstensen-Roth framework to explain such preemption or exemption. Three elements are necessary: state law, federal law, constitutional law, or some generally accepted public interest goal must authorize the organization to regulate some aspect of the market, the regulation at issue must be within the scope of that authorization, and the process used to adopt and implement the regulation must be appropriate under the circumstances. Naked restraints satisfying these elements are exempt from antitrust law review, and courts applying antitrust law should not undertake to determine the substantive “reasonableness” of such regulations. This framework adheres to the general rule that naked restraints of competition are always per se illegal unless exempt and provides a clearer basis for determining when and whether a restraint can be lawful. The three Supreme Court decisions reviewing FTC challenges to conspiracies among dentists to restrict and regulate competition in dental care provide the basis to illustrate and test this approach
Supreme Court Journalism: From Law to Spectacle?
No full textFew people outside certain specialized sectors of the press and the legal profession have any particular reason to read the increasingly voluminous opinions through which the Justices of the Supreme Court explain their interpretations of the Constitution and laws. Most of what the public knows about the Supreme Court necessarily comes from the press. That fact raises questions of considerable importance to the functioning of our constitutional democracy: How, for example, does the press describe the work of the Supreme Court? And has the way in which the press describes the work of the Court changed over the past several decades?
This Article seeks to address those questions by comparing the language used in print media coverage of two highly salient cases involving similar legal issues decided fifty years apart: Brown v. Board of Education and Parents Involved in Community Schools v. Seattle School District No. 1. Our study suggests that, at least in highly salient cases, the nature of print media coverage may well have changed dramatically during that fifty-year interval. More specifically, our study suggests that while the mid-twentieth century press described the Court’s decisions largely in terms of the legal questions presented, the contemporary press seems more likely to describe the Court’s decisions in non-legal terms—as something resembling a spectacle, in which unelected judges are presumed to decide cases, not on properly contested legal grounds, but based on their respective political commitments.
That conclusion is striking. First, it suggests that in the ongoing scholarly debate over the nature of the Justices’ approach to their work, the press has chosen sides. Rather than closely interrogating the Court’s work to determine whether particular analyses and results can be defended on legal grounds, contemporary reporting seems to proceed on the assumption that that question lacks salience—because we already know that the Justices’ political views and allegiances are the true drivers of Supreme Court decisions. Thus, contemporary press coverage tends to emphasize such factors as the political affiliation of the president who appointed a particular Justice. Second, it raises questions about the way in which the contemporary press is discharging its responsibility to educate the public about the Court and its work. It also raises the possibility that the public will become predisposed to doubt the Court’s legitimacy, and, indeed, the very legitimacy of the American system of judicial review.
If the Court’s decisions really reflect nothing more than the Justices’ political predilections and commitments, or those of the elites to which they belong, it is important for the public to know that. Nothing could be more important than discovering and documenting the fact that the Justices wear no clothes. On the other hand, whether Supreme Court decisions deserve to be viewed in that way is a question that needs to be tested through a careful examination of the Court’s work product. It is something to be proved rather than presumed. The contemporary print media’s seemingly casual assumption that the main point about reporting on the Supreme Court is not to test the validity of the Court’s reasoning, and explore its flaws, but to try to trace connections between the Justices’ voting behavior and their political or other commitments, may well corrode public confidence in the Court. If that occurs unnecessarily, and without adequate justification, the consequences for the institution of judicial review may well be dire. Moreover, if the public’s expectations are lowered, so too may be the standards the Justices set for themselves and each other. In other words, if the press leads us to believe that the Court’s work product is nothing more than politics, that may well become a self fulfilling prophecy—if it has not already happened
COVID-19 and American Democracy
Full text linkThis article discusses the response of the United States Government to the COVID-19 Pandemic from January through June 19, 2020.In particular, the article focuses on the constitutional and legal background of that response. The article was prepared for a symposium in the Italian journal Il diritti dell\u27economia on responses to the COVID-19 pandemic by governments around the world
Federalizing Bank Governance
Full text linkCongress and federal financial regulators have long prioritized the safety and soundness of banking firms. But at the same time, the directors and officers of banking firms are legally bound to prioritize shareholder wealth maximization, which creates incentives for risk-taking that work against these regulatory goals. This shareholder primacy norm has long been a central feature of corporate governance, but as I describe in this Article its application to banks was not a deliberate policy choice but rather a historical accident. Indeed, banks possess several unique features that make shareholder wealth maximization an inapt governance priority for them. Banks are highly leveraged, which increases the importance of creditor agency costs. Banks also enjoy government guarantees, either explicit or implicit, on their short-term debt, and thus their governance is a matter of public concern. Finally, bank failures result in high negative externalities, and this also creates a strong public interest in bank safety and soundness. This Article argues that a new federal governance regime for banking institutions is appropriate and consistent with the historical purposes of banking regulations and charter oversight in the United States. Furthermore, such a regime would reduce the tensions between the law of state entities and the sprawling federal banking regulatory framework created by Congress, and harmonize the internal governance of banking firms with the broader goals of external banking regulations. Finally, I offer some thoughts on the key principles that should be present in any such federal governance regime for banking. For too long, we have tolerated a “cat-and-mouse” dynamic in banking, one in which regulators have sought to identify and address risky practices while knowing that the directors and officers of banking firms have strong incentives to take on higher risk. By changing this paradigm and realigning the incentives inherent in banking governance, we can take a major step towards ensuring long-term stability in our financial system