This Note proceeds in four parts. Part I briefly looks back at the FDA’s history and the impact of two significant drug crises in establishing the agency’s current framework before explaining the current drug development process. Part II recounts previous challenges to this regulatory framework, which ultimately led to the development of the current expanded access program. Part II also examines the current expanded access program and, more specifically, the evaluation criteria applied by three of its key decisionmakers: the treating physician; the manufacturer; and the FDA.
Part III traces the beginnings of the right to try movement, examining the rationale for the laws and exploring how social media and increased direct-to-consumer advertising of approved drugs possibly created an opening for widespread support of these laws. Part III also explores why the FDA’s efforts to address criticisms of the expanded access program were unable to dissuade enactment of the Right to Try Act. Part IV provides an overview of the Right to Try Act and how the Act differs from expanded access. Part IV further explores why, in general, mainstream industry likely will not adopt the right-to-try pathway, before arguing that pharmaceutical and biotechnology companies should avoid maintaining their current positions regarding pre-approval access, and instead address some of the criticisms raised during the right-to-try movement by (1) revising their existing expanded access policies and (2) improving clinical trial access.
During the 2016 Presidential campaign, the average adult saw at least one “fake news” item on social media. The people distributing the articles had a variety of aims and operated from a variety of locations. Among the locations we know about, some were in Los Angeles, others in Macedonia, and, yes, others were in Russia. The Angelenos aimed to make money and sow chaos. The Macedonians wanted to get rich. And the Russians aimed to weaken Hillary Clinton’s candidacy for president, foster division around fraught social issues, and make a spectacle out of the U.S. election. To these ends, the Russians mobilized trolls, bots, and so-called “useful idiots,” along with sophisticated ad-tracking and micro-targeting techniques to strategically distribute and amplify propaganda. The attacks are ongoing.
Cheap distribution and easy user targeting on social media enable the rapid spread of disinformation. Disinformative content, like other online political advertising, is “micro-targeted” at narrow segments of the electorate, based on their narrow political views or biases. The targeting aims to polarize and fragment the electorate. Tracing the money behind this kind of messaging is next to impossible under current regulations and advertising platforms’ current policies. Voters’ inability to “follow the money” has implications for our democracy, even in the absence of disinformation. And of course, an untraceable flood of disinformation prior to an election stands to undermine voters’ ability to choose the candidate that best aligns with their preferences.
This is the first academic work to show the need for, or to offer, a regulatory framework for exchange-traded funds (“ETFs”). The economic significance of this financial innovation is enormous. U.S.-listed ETFs now hold more than $3.6 trillion in assets and comprise seven of the country’s ten most actively traded securities. ETFs also possess an array of unique characteristics raising distinctive concerns. They offer what we here conceptualize as a nearly frictionless portal to a bewildering, continually expanding universe of plain vanilla and arcane asset classes, passive and active investment strategies, and long, short, and leveraged exposures. And we argue that ETFs are defined by a novel, model-driven device that we refer to as the “arbitrage mechanism,” a device that has sometimes failed catastrophically. These new products and the underlying innovation process create special risks for investors and the financial system.
Recent antitrust decisions and policy initiatives by both the Department of Justice (“DOJ”) and Department of Transportation (“DOT”) have shaped the current U.S. airline landscape. The consolidation trend is not unique to the U.S. domestic air transportation market. The emergence of three global airline alliances—together accounting for around 80% of air traffic across the transatlantic, transpacific, and Europe–Asia markets—has transformed the international air transportation market as well. This Note evaluates the results of the DOJ’s antitrust approach to U.S. airline mergers and reconciles these results with the DOT’s “public interest” emphasis in determining airline applications for antitrust immunity (“ATI”). Given the current domestic market, it is likely that the remaining legacy carriers will leverage their respective global alliances and seek ATI with foreign airlines for continued network growth.
Part I of this Note tracks the tumultuous history of the U.S. airline industry from deregulation to its current health. Part II presents the legal framework, including U.S. antitrust laws, that govern domestic airline mergers and international ATI. Part III proposes practical solutions for the DOT to improve the ATI regulatory process and incubate open market competition, thereby better serving passengers and airlines by edging closer to deregulation.
This Article examines what we term “regulatory entrepreneurship”—pursuing a line of business in which changing the law is a significant part of the business plan. Regulatory entrepreneurship is not new, but it has become increasingly salient in recent years as companies from Airbnb to Tesla, and from DraftKings to Uber, have become agents of legal change. We document the tactics that companies have employed, including operating in legal gray areas, growing “too big to ban,” and mobilizing users for political support. Further, we theorize the business and law-related factors that foster regulatory entrepreneurship. Well-funded, scalable, and highly connected startup businesses with mass appeal have advantages, especially when they target state and local laws and litigate them in the political sphere instead of in court.
Finally, we predict that regulatory entrepreneurship will increase, driven by significant state and local policy issues, strong institutional support for startup companies, and continued technological progress that facilitates political mobilization. We explore how this could catalyze new coalitions, lower the cost of political participation, and improve policymaking. However, it could also lead to negative consequences when companies’ interests diverge from the public interest.
A new breed of “app-based” ride-for-hire providers has caused a stir in California, helped rewrite the state’s rules governing ridesharing, and stoked tensions among taxicab drivers, state and local regulators, and the technology companies behind the new apps. UberX, Lyft, and Sidecar are among the most well-known of the new app-based rideshare services, which allow customers to hail a ride using smartphone applications by connecting them with drivers who also use the apps. Critically, the drivers need not be professionals; rather, they merely need to have downloaded a ridesharing app and been cleared by the app provider to drive. For a time, the app-based rideshare companies pointed to these novel aspects of their services to flout regulation entirely. New laws and rules in California, however, provide for the regulation of the nascent industry under a statewide scheme mandating insurance coverage, driver background checks, and other safety-based requirements. In substance, the new rules signal the state’s tacit approval of the development of app-based ridesharing services. Users of these app-based services, which are currently available only in major metropolitan areas like Los Angeles, have been impressed by the apps’ lower prices and perceived higher quality of service.
Throughout its history, the sport of boxing has been known as much for its corruption and scandals as its courageous fighters and memorable bouts. Indeed, it has been referred to by some as the “red light district of sport[s].” Even today, boxing is plagued by fixed fights, exploitative promoters, greedy sanctioning organizations, unnecessary health risks to boxers, incompetent state athletic commissions, and a confusing array of weight divisions with a multitude of world champions. In fact, some of these issues were so rampant that Congress, in 1996 and 2000, passed federal legislation attempting to address them.
“Ring-fencing” is often touted as a regulatory solution to problems in banking, finance, public utilities, and insurance. However, both the precise meaning of ring-fencing, as well as the nature of the problems that ring-fencing regulation purports to solve, are ill-defined. This Article examines the functions and conceptual foundations of ring-fencing. In a regulatory context, the term can best be understood as legally deconstructing a firm in order to more optimally reallocate and reduce risk. So utilized, ring-fencing can help to protect certain publicly beneficial activities performed by private-sector firms, as well as to mitigate systemic risk and the too-big-to-fail problem inherent in large financial institutions. If not structured carefully, however, ring-fencing can inadvertently undermine efficiency and externalize costs.
Voluntary, altruistic bone marrow donation is currently the only way for a patient to receive a bone marrow transplant. Unfortunately, bone marrow supply from altruism falls far short of demand, making our current system insufficient. Although scholars have proposed numerous avenues for change in the organ donation system, no change has occurred. One popular proposal is to remove the ban on compensation for organ donors, a proposition that implicates many ethical and moral concerns. These moral concerns include the commodification of the human body, the exploitation of poor and ethnic minority populations, and the general repugnance that some feel toward the idea of selling one’s body. If compensation for bone marrow donation were allowed, we may be able to overcome these moral and ethical concerns both conceptually and constitutionally. For example, the ethical dilemmas that surround bone marrow donation are somewhat abated by the rise of new technologies that have made bone marrow donation much less intrusive.
The law, when enforced, can be used to punish. It can be used to articulate social norms and standards, or to define and impose responsibilities. The law can also, however, be used to change incentives. When designed and implemented properly, a good law establishes an incentive structure to align legal responsibility with the actors most able to change a set of results–actors who possess the information, the institutional capacity, and the practical ability to make a difference in a situation our society seeks to improve. In the 111th Congress, Representative Jim McDermott proposed just such a law. The Conflict Minerals Trade Act took note of America’s role in the devastating humanitarian crisis it may be inadvertently fueling: the situation in the Democratic Republic of Congo (“DRC” or “DR Congo”), home to the minerals used in nearly every electronic product known to man. Indeed, as the conflict in DR Congo reaches catastrophic proportions, the interests of a broad range of actors have become affected–and not just those in the human rights sector. Mineral wealth extracted from DR Congo is likely inside of your cell phone, your laptop, and your iPod–raising issues of personal responsibility as well as corporate ethics. As individuals confront their consciences and investors contemplate their stock portfolios, issues once relegated to the realm of international human rights law have now entered many of our homes and purses without us realizing. The Conflict Minerals Trade Act, by altering an incentive structure, aimed to change that unawareness by bringing our trade legislation in line with both our best interests and our ethical responsibilities.