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This Note discusses the regulatory regime developed by the Food and Drug Administration (FDA) to ensure generic drug quality through premarket approval. The Hatch-Waxman Act effectively created the contemporary generic drug industry in 1984, and today, this industry saves the United States billions of dollars in medical costs. The legal-scientific concept of “bioequivalence” is central to the Hatch-Waxman regime, and its meaning has developed through statutory, regulatory, an advisory pathways in Congress and at the FDA. In this Note, I argue that the FDA’s current approach to promulgating standards for bioequivalence—largely based on guidance documents—threatens the agency’s ability to sustain comprehensive and authoritative regulation in the future. Guidance documents and petition responses are not subject to public input according to the standards of the Administrative Procedure Act (APA), and may create confusion among regulated entities and trouble for consumers. Nevertheless, courts repeatedly have deferred to the FDA’s choice of policymaking form and have found challenges under the APA to be nonjusticiable for lack of standing and ripeness. I argue that this deference should be attenuated and justiciability should be restored, not because generic drugs approved under the current regime are demonstrably dangerous to patients, but because systematic foreclosure of public input and judicial oversight is an unsustainable regulatory approach.

The history of the U.S. financial markets is peppered with economic crises. A few scholars have argued that in the wake of these events, the combination of widespread media attention and a flurry of congressional action has led to the hurried creation of sweeping remedial legislation. Indeed, these scholars maintain that in seeking to put out the flames of panic and financial instability, such regulations have often been mismatched to the problems they intended to address. My Note enters the fore and argues that the Volcker Rule and the amendments to the Investment Advisers Act of 1940, promulgated in response to the Financial Crisis of 2008 as part of the Dodd-Frank Wall Street Reform and Consumer Protection Act, are examples of financial market regulation that go beyond the concerns that led to their enactment. Specifically, this Note explores these regulations as they apply to private equity (PE) funds and contends that they each bring the PE industry within the purview of regulatory scrutiny in a way that may have negative implications for our economic recovery. While the need to be forward-looking remains present in any legislative scheme, this Note takes the position that we are currently facing uncertain economic times that require a response more closely tied to the conduct that led to the Crisis.

This Note presents two arguments. First, the Digital Millennium Copyright Act’s (DMCA) liability safe harbors are inapposite for private cloud services. Private cloud services are increasingly common offerings where consumers upload content, such as music, movies, or books, to personal cloud storage space, then download or stream that content to a multitude of devices. Although granting safe harbor immunity from secondary liability for user infringement would further the DMCA’s policy to promote technological innovation, doing so would completely ignore the DMCA’s other policy—to protect copyright. Currently, the DMCA protects copyright through its notice-and-takedown procedures, but these provisions depend on the ability of copyright holders to monitor users’ public actions—an impossibility on private cloud services. Second, the private cloud services problem is symptomatic of a larger problem in the DMCA: Its regulatory-like detail and specificity undermine its application to new technologies. The solution to both problems is an administrative one: Delegate rulemaking power to narrowly define safe harbor qualification when new technologies, like private cloud services, are valuable but also both ripe for infringement and unaddressed by the DMCA.

Madison Lecture

In his James Madison Lecture, Judge Robert A. Katzmann argues that federal courts have much to learn from Congress and agencies about how statutes should be interpreted. In the voluminous discussion of how courts should construe statutes, there has generally been little consideration given to an appreciation of how Congress actually functions; how Congress signals its meaning; and what Congress expects of those interpreting its laws. In examining that lawmaking process, Judge Katzmann looks to how legislators signal their legislative meaning to the first inter- preters of statutes—agencies—and to how agencies regard Congress’s work product in interpreting and executing the law. He contends that Congress intends that its work be understood through its institutional processes and reliable legisla- tive history. In our constitutional system in which Congress is charged with enacting laws, the methods by which Congress makes its purposes known—through text and reliable accompanying materials—should be respected, lest the integrity of legislation be undermined. Agencies well appreciate and are responsive to Congress’s perspective that such materials are essential to construing statutes. By understanding statutory interpretation as an enterprise involving other institutions, we can better address the question of how courts ought to interpret statutes. Against that background, Judge Katzmann examines two approaches to the judicial inter- pretation of statutes—purposivism and textualism—and concludes with a discus- sion of practical ways in which Congress may better signal its meaning and how courts may better inform Congress of the problems courts identify in the statutes they review.

What motivates substantive presumptions about how to interpret statutes? Are they like statistical heuristics that aim to predict Congress’s most likely behavior, or are they meant to protect certain underenforced values against inadvertent legislative encroachment? These two rationales, fact-based and value-based, are the extremes of a continuum. This Note uses the presumption against extraterritoriality to demonstrate this continuum and how a presumption can shift along it. The presumption operates to diminish the likelihood that a federal statute will be read to extend beyond the borders of the United States. The presumption has been remarkably stable for decades despite watershed changes in the principles—customary international law and conflict of laws—that once supported it. As the presumption’s normative justifications have diminished, a new justification has grown in importance. Today, the presumption is often justified as a stand-in for how Congress typically legislates. This Note argues that this change makes the presumption less defensible but even harder to overcome in individual cases.

This Note seeks to contribute to the revival of an underutilized section of the Fair Housing Act intended not just to ban individual acts of discrimination but also to achieve integrated residential neighborhoods. The gulf between lofty, vague federal policy and the local governments responsible for zoning, planning, and housing siting decisions, however, has stymied this pro-integration purpose. Although all state and most local governments are required to certify that they are meeting their obligation to “affirmatively further fair housing,” this certification has rarely risen above mere boilerplate. Building on recent litigation that reinvigorated the Act’s positive purpose with some skeletal substance and a new proposed rule seeking to improve procedural compliance, this Note proposes an expanded federal rule to define meaningfully this obligation through concrete, quantitative benchmarks. In the absence of such an expanded rule, this Note suggests guidance on how a court might evaluate compliance with this capacious statutory standard by using housing segregation data in a burden-shifting framework. This Note concludes by addressing workability and constitutionality concerns, evaluating practical hurdles, and testing the proposed rule against the Roberts Court’s jurisprudence on equal protection and federalism. The ultimate purpose is a pragmatic program to achieve the still-unrealized goal that animated the Act’s passage: a truly integrated nation.

Critics have accused transnational regulatory networks (TRNs) such as the Basel Committee on Banking Supervision of being undemocratic, but they rarely step back and ask if democracy is the right criterion for evaluating regulatory networks. Such critics often point to the seemingly robust checks of domestic administrative law and argue that similar mechanisms should constrain TRNs. However, the Federal Reserve Board of Governors, a significant banking regulator in the United States, is not democratic. Using the Federal Reserve Board as a case study, this Note challenges critics’ claims that there is such a wide gulf between domestic and global procedures.

Enforcement of law is at the core of the President’s constitutional duty to “take Care” that the laws are faithfully executed, and it is a primary mechanism for effecting national regulatory policy. Yet questions about how presidents oversee agency enforcement activity have received surprisingly little scholarly attention. This Article provides a positive account of the President’s role in administrative enforcement, explores why presidential enforcement has taken the shape it has, and examines the bounds of the President’s enforcement power. It demonstrates that presidential involvement in agency enforcement, though extensive, has been ad hoc, crisis-driven, and frequently opaque. The Article thus reveals the need for institutional design reforms—namely more coordination across agencies and greater disclosure of enforcement policy. The seeds for such reforms can be found in several recent efforts that have yet to be made systematic. Concerns about politicization of law enforcement should not override the considerable benefits that would derive. Rather, by acknowledging the President’s role in, and responsibility for, enforcement, we can better ensure the structure and transparency that promote appropriate presidential influence.

The Supreme Court held in Burford v. Sun Oil Co. that federal courts, through an exercise of equitable discretion, could abstain from asserting subject matter jurisdiction over challenges to state administrative agency orders. Since Burford, the Court has failed to reconcile abstention with either Congress’s subject matter jurisdiction statutes or the Constitution, which both arguably require federal courts to exercise jurisdiction when the subject matter is proper. Instead of relying on equitable discretion, I believe federal courts can and should ground Burford abstention in constitutional and statutory restrictions on the types of power that federal courts may exert. Article III of the Constitution and the federal question, diversity, and removal jurisdiction statutes require federal courts to abstain from asserting jurisdiction when doing so would require federal courts to take nonadjudicative action.

In response to the challenges of globalization, U.S. agencies at times reach agreements on regulations with their foreign counterparts and then subsequently implement those regulations domestically. Some have suggested that this model of rulemaking gives agencies determinative incentives to implement the international regulation as negotiated—and thus to ignore public comments in the domestic rulemaking process. In this Note, I use the Basel Accords as case studies to show that agencies do not necessarily implement international agreements as a fait accompli. Nevertheless, I argue that international agreements may illegitimately influence the domestic rulemaking process and that courts must therefore be more vigilant in reviewing these types of regulations.