The Indirect Consequences of Expanded Off-Label Promotion

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as suggested in the dissenting opinion in United States v. Caronia, a high-profile 2012 case regarding off-label promotion—protections for off-label promotion might affect the FDA’s decision-making in areas other than drug promotion, and analyzes precisely what those effects could be in light of the FDA’s current statutory authority

Toward Coherent Federal Oversight of Medicine

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice—the activities of physicians and other health care professionals—while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a primarily state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to conventional wisdom, the federal government is deeply entangled in regulating medical practice, and such federal regulation is lawful. After examining the goals of federalism within the context of medicine, this Article proposes an alternate paradigm for guiding decisions about when the federal government should be involved in overseeing medicine: Congress and administrative agencies should exert federal authority when medical practice contributes to a national public health problem that states cannot address. This framework is applied to one pressing public health problem to which medical practice contributes—antibiotic resistance—to show how the framework could be implemented. Federal oversight of medical practice under this framework would be more principled and transparent than the scheme of federal control that is in place today

The Indirect Consequences of Expanded Off-Label Promotion

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as suggested in the dissenting opinion in United States v. Caronia, a high-profile 2012 case regarding off-label promotion—protections for off-label promotion might affect the FDA’s decision-making in areas other than drug promotion, and analyzes precisely what those effects could be in light of the FDA’s current statutory authority

Pharmaceutical Federalism

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013, Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends into medical practice regulation in some circumstances. It then begins to explore implications outside of the preemption context, arguing that state regulatory efforts may also help to inform our general understanding of both the scope of the FDA’s jurisdiction and the relationship between the FDA and the states

Toward Coherent Federal Oversight of Medicine

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to the conventional wisdom, the federal government is deeply entangled in regulating medical practice, and such federal regulation is lawful. After examining the goals of federalism within the context of medicine, the Article proposes an alternate paradigm for guiding decisions about the division of labor between states and the federal government: Congress and administrative agencies should exert federal authority when medical practice contributes to a national public health problem for which state regulation is inadequate. This framework is applied to one pressing public health problem to which medical practice contributes – antibiotic resistance – to show how the framework could be implemented. Federal oversight of medical practice under this framework would be more principled and transparent than the scheme of federal control that is in place today

Is It Cheating to Use Cheetahs?: The Implications of Technologically Innovative Prostheses for Sports Values and Rules

This Article uses the case of Oscar Pistorius – the South African runner and amputee who competed with blade-like, lower-leg prostheses – to analyze how the International Association of Athletic Federations (IAAF), the world governing body of track and field, should regulate elite athletes’ use of innovative prostheses. The Article argues that the Court of Arbitration of Sport correctly decided that Pistorius should be permitted to compete in able-bodied competitions, but that the IAAF rule on which the decision was based failed to account for the full range of sports values implicated by the use innovative prostheses. The Article proposes that IAAF amend its rule to incorporate more sports values, including protecting athletes’ safety and preserving the fundamental nature of the sport, and clarify how it would assess new technologies in the future

The FDA’s Power Over Non-Therapeutic Uses of Drugs and Devices

Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the agency itself have sought reasonable limits on the definitions. This Article critiques one limit that is sometimes offered: that the FDA cannot regulate certain non-therapeutic technologies because those technologies cannot be shown to be safe and effective. A careful review of the FDA’s past decisions on non-therapeutic uses reveals that this reasoning is descriptively incorrect. Further, examining the purposes of FDA oversight demonstrates that the agency is not necessarily normatively required to set an insurmountable bar for showing the safety and effectiveness of non-therapeutic uses. Reconsidering this reasoning as a limit on FDA jurisdiction is warranted at a time when evolutions in both policy and science are opening the door to a potentially diverse market of new, or newly legal, non-therapeutic technologies

Compassionate Use of Experimental Therapies: Who Should Decide?

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation\u27s unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients\u27 requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy\u27s laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include more specific criteria for authorizing compassionate use. But even where regulatory agencies make decisions based on clear rules, difficult questions will arise