Law Commons^™

Certificates Of Public Advantage: A Valuable Tool Or Diminishing Allure?, Abdur Rahman Amin

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Prosecuting Excessive Pricing Of Pharmaceuticals Under Competition Law: Evolutionary Development, Frederick M. Abbott

Scholarly Publications

Prosecution of pharmaceutical companies for excessive pricing of products under competition law is now a reality. As recently as a decade ago, such prosecutions were virtually nonexistent. That situation has changed dramatically as competition authorities in Europe and South Africa have pursued a significant number of such prosecutions and have levied substantial fines against the investigated parties. While the United States has traditionally led in policing the pharmaceutical market against anticompetitive misconduct, in this specific arena it has fallen behind, principally because federal courts so far have refused to acknowledge excessive pricing as a cause of action under Section 2 …

Renewing Faith In Antitrust: Unveiling The Hidden Network Behind Pharmaceutical Product Hopping, Victoria Field

Fordham Journal of Corporate & Financial Law

Patents grant time-limited market exclusivity to drug manufacturers, meaning that other companies are prohibited from copying and selling the patented pharmaceutical. This allows manufacturers to lawfully charge monopoly prices. Generic competition starts at the expiration of the patent. To maintain coveted monopoly power, manufacturers often release an alternative formulation of the drug with a fresh patent that enjoys continued market exclusivity. Manufacturers who can convert their consumer base to the new formulation can continue charging peak prices. This process, called “product hopping,” has been the target of significant antitrust inquiry, with mixed results.

A product hop may be the result …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

All Faculty Scholarship

New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino

Brooklyn Law Review

The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …

Specialty Drugs And The Health Care Cost Crisis, Sharona Hoffman, Isaac D. Buck

Faculty Publications

Specialty drugs, often dispensed by specialty pharmacies, are among the most expensive drugs on the market. They are significant contributors to the American health care cost problem, but in many ways they escape public and regulatory scrutiny. Surprisingly, medications are designated as specialty drugs by pharmacy benefit managers (PBMs), entities that are part of the insurance industry, rather than by the Food and Drug Administration or medical authorities.

Specialty drugs have thus far received little attention in the legal literature. Yet, they raise important legal and regulatory questions. For example, there are no federal government rules (and only a handful …

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

All Faculty Scholarship

Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …

How Much Of Health Care Antitrust Is Really Antitrust?, Spencer Weber Waller

Spencer Weber Waller

No abstract provided.

The Duality Of Provider And Payer In The Current Healthcare Landscape And Related Antitrust Implications, Julia Kapchinskiy

San Diego Law Review

Health care landscape has changed with the introduction of the ACA and will keep changing due to the proposed repeal. The only constant is the desire of health plans and providers to maximize profits and minimize costs, which is attainable through consolidation. This Comment advocates a revision of the existing antitrust guidelines that would (1) recognize unique nature of health care market, (2) be independent from the current or proposed legislation to the maximum possible extent, and (3) reflect the insurer-provider duality, which heavily influences the quality and accessibility of the healthcare for the consumer.

Healthcare Mergers And Acquisitions In An Era Of Consolidation: A Review And A Call For Agency Collaboration In Antitrust Enforcement, Anna Molinari

Pepperdine Law Review

Healthcare companies are consolidating at an alarming rate. From hospitals, to providers’ offices, to insurance companies, there are increasingly fewer consumer choices and more monopolies, which calls for heightened antitrust enforcement. Interestingly, antitrust enforcement authority in the healthcare industry is shared between the Federal Trade Commission (FTC), which presides over hospital and provider mergers, and the Department of Justice (DOJ), which presides over health insurance mergers. Although the FTC has challenged many hospital and provider mergers, the DOJ has only challenged six health insurance mergers. Furthermore, last year, the DOJ ultimately approved all health insurance mergers. In 2017, in United …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to confirm …

The Prescription Drug Pricing Moment: Using Public Health Analysis To Clarify The Fair Competition Debate On Prescription Drug Pricing And Consumer Welfare, Ann Marie Marciarille

Faculty Works

Fair competition law and public health law talk past each other when discussing pharmaceutical pricing and distribution. The former cannot agree on the relevant definition of consumer welfare. The latter does not fully comprehend the highly complex but inherently collective nature of pharmaceutical drug acquisition in the United States. This essay proposes to inject public health discourse into this debate to enrich it, focus it, and render it more accessible to those who must live by its outcome.

Optimizing Private Antitrust Enforcement In Health Care, Anne Marie Helm

Saint Louis University Journal of Health Law & Policy

Americans are paying too much for health care services and insurance, in large part due to insufficiently competitive markets. Waves of consolidation have fortified providers and insurers with market power, resulting in higher prices and lower quality for consumers. As antidotes, advocates have proposed various legislative, regulatory, and enforcement solutions. Yet, unlike public antitrust enforcement, private antitrust enforcement is either not mentioned or criticized as sour grapes from competitors or a money grab by consumers. Instead of ignoring or bashing private litigation, those looking to address the health care pricing crisis in the United States should be looking to optimize …

Competition As Policy Reform: The Use Of Vigorous Antitrust Enforcement, Market-Governance Rules, And Incentives In Health Care, Emilio Varanini

Saint Louis University Journal of Health Law & Policy

In health care, the increase in market concentration on both the insurer side and the provider side has led to insurers and providers acquiring market power. Insurers and providers, in turn, have used that market power to charge higher prices to employers providing employees with medical care without corresponding increases in the quality of that care. Responding more generally to the increase in market concentration in many industries in the United States with a range of inimical effects for the nation’s economy, the Obama Administration suggested a range of policy solutions that this article groups under the term “Competition as …

How Much Of Health Care Antitrust Is Really Antitrust?, Spencer Weber Waller

Faculty Publications & Other Works

No abstract provided.

Ftc V. Phoebe Putney And Municipalities As Nongovernments, Peter F. Nascenzi

Northwestern University Law Review

American courts have long struggled with categorizing municipalities. They treat municipalities sometimes as private corporations, sometimes as governmental bodies, and sometimes as something in between. This uncertainty provides a shaky foundation for local government law and hampers its development. Local governments are not sure of their powers, and states are unable to create a comprehensive vision of municipal governance. When federal law is involved, the situation is muddled further.

In FTC v. Phoebe Putney, the Supreme Court’s application of the state action doctrine unnecessarily injected federal antitrust law into the relationship between states and municipalities. The state action doctrine …

Hospital Mergers And Economic Efficiency, Roger D. Blair, Christine Piette Durrance, D. Daniel Sokol

D. Daniel Sokol

Consolidation via merger both from hospital-to-hospital mergers and from hospital acquisitions of physician groups is changing the competitive landscape of the provision of health care delivery in the United States. This Article undertakes a legal and economic examination of a recent Ninth Circuit case examining the hospital acquisition of a physician group. This Article explores the Saint Alphonsus Medical Center-Nampa Inc. v. St. Luke’s Health System, Ltd. (St. Luke’s) decision—proposing a type of analysis that the district court and Ninth Circuit should have undertaken and that we hope future courts undertake when analyzing mergers in the …

Assembled Products: The Key To More Effective Competition And Antitrust Oversight In Health Care, William M. Sage

Faculty Scholarship

This Article argues that recent calls for antitrust enforcement to protect health insurers from hospital and physician consolidation are incomplete. The principal obstacle to effective competition in health care is not that one or the other party has too much bargaining power, but that they have been buying and selling the wrong things. Vigorous antitrust enforcement will benefit health care consumers only if it accounts for the competitive distortions caused by the sector’s long history of government regulation. Because of regulation, what pass for products in health care are typically small process steps and isolated components that can be assigned …

Hospital Mergers And Economic Efficiency, Roger D. Blair, Christine Piette Durrance, D. Daniel Sokol

UF Law Faculty Publications

Consolidation via merger both from hospital-to-hospital mergers and from hospital acquisitions of physician groups is changing the competitive landscape of the provision of health care delivery in the United States. This Article undertakes a legal and economic examination of a recent Ninth Circuit case examining the hospital acquisition of a physician group. This Article explores the Saint Alphonsus Medical Center-Nampa Inc. v. St. Luke’s Health System, Ltd. (St. Luke’s) decision—proposing a type of analysis that the district court and Ninth Circuit should have undertaken and that we hope future courts undertake when analyzing mergers in the …

Antitrust Enforcement Against Pharmaceutical Product Hopping: Protecting Consumers Or Reaching Too Far?, Tyler J. Klein

Saint Louis University Journal of Health Law & Policy

Pharmaceutical drugs are the backbone of modern medicine, which makes the continued development of new drugs essential and puts many lives in the hands of the brand-name pharmaceutical companies that develop these new treatments. Currently, antitrust litigation is being used to strike a balance between the innovator’s right to earn a profit and the need for generic drug companies to make these drugs available to the masses that need them. Antitrust law stops brand-name companies from taking over the market and excluding generics, but it should not be used to impose harsh remedies that restrict the thing that we all …

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Quality-Enhancing Merger Efficiencies, Roger D. Blair, D. Daniel Sokol

D. Daniel Sokol

The appropriate role of merger efficiencies remains unresolved in US antitrust law and policy. The Patient Protection and Affordable Care Act (ACA) has led to a significant shift in health care delivery. The ACA promises that increased integration and a shift from quantity of performance through increased competition will create a system in which quality will go up and prices will go down. Increasingly, due to the economic trends that respond to the ACA, including considerable consolidation both horizontally and vertically, it is imperative that the antitrust agencies provide an economically sound and administrable legal approach to efficiency enhancing mergers. …

Quality-Enhancing Merger Efficiencies, Roger D. Blair, D. Daniel Sokol

UF Law Faculty Publications

The appropriate role of merger efficiencies remains unresolved in US antitrust law and policy. The Patient Protection and Affordable Care Act (ACA) has led to a significant shift in health care delivery. The ACA promises that increased integration and a shift from quantity of performance through increased competition will create a system in which quality will go up and prices will go down. Increasingly, due to the economic trends that respond to the ACA, including considerable consolidation both horizontally and vertically, it is imperative that the antitrust agencies provide an economically sound and administrable legal approach to efficiency enhancing mergers. …

Licensing Health Care Professionals, State Action And Antitrust Policy, Roger D. Blair, Christine Piette Durrance

UF Law Faculty Publications

In this Essay, we raise some economic concerns about the wisdom of conferring antitrust immunity on professional licensing boards, which are often comprised of members of the profession and therefore apt to be motivated by self-interest rather than the public interest. In Part II, we examine the political economy of special interest legislation, which suggests that little public good results from replacing competitive market forces with self-regulation. In Part III, we employ a basic economic model to generate predictions of the economic effects of professional licensing. Part IV provides a survey of the empirical research in this area, which confirms …

Rediscovering Capture: Antitrust Federalism And The North Carolina Dental Case, Herbert J. Hovenkamp

All Faculty Scholarship

This brief essay analyzes the Supreme Court's 2015 decision in the North Carolina Dental case, assessing its implications for federalism. The decision promises to re-open old divisions that had once made the antitrust "state action" doctrine a controversial lightning rod for debate about state economic sovereignty.

One provocative issue that neither the majority nor the dissenters considered is indicated by the fact that nearly all the cartel customers in the Dental case were located within the state. By contrast, the cartel in Parker v. Brown, which the dissent held up as the correct exemplar of the doctrine, benefited California growers …

The "Uberization" Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan

Fazal Khan

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined …

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

All Faculty Scholarship

As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

All Faculty Scholarship

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.

As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to …

Our 'Patchwork' Health Care System: Melodic Variations, Counterpoint, And The Future Role Of Physicians, William M. Sage

Faculty Scholarship

This Foreword to a forthcoming symposium on the "patchwork" health care system to be published in the Houston Journal of Health Law & Policy considers whether current reactions to fragmentation in health care represent minor variations on a longstanding theme in US health policy or offer a more substantial counterpoint to that theme. The theme is this: that perfect physicians should be allowed to control health care even if safeguards are needed in practice because real physicians are not perfect. The Foreword previews four scholarly articles featured in the published symposium. It concludes that, while all the articles present original …

Anticompetitive Patent Settlements And The Supreme Court's Actavis Decision, Herbert J. Hovenkamp

All Faculty Scholarship

In FTC v. Actavis the Supreme Court held that settlement of a patent infringement suit in which the patentee of a branded pharmaceutical drug pays a generic infringer to stay out of the market may be illegal under the antitrust laws. Justice Breyer's majority opinion was surprisingly broad, in two critical senses. First, he spoke with a generality that reached far beyond the pharmaceutical generic drug disputes that have provoked numerous pay-for-delay settlements.

Second was the aggressive approach that the Court chose. The obvious alternatives were the rule that prevailed in most Circuits, that any settlement is immune from antitrust …