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The Biologics Price Competition and Innovation Act at 10—A Stocktaking
No full textOn March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (a.k.a. “Obamacare”). The purpose of BPCIA was to create in biologics a regime similar to that of the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) and, in so doing, to open biologics markets to competition and, subsequently, lower the price of these expensive and increasingly important pharmaceuticals. Using original data, this Essay takes stock of the decade that has passed since the enactment of BPCIA. The Essay surveys the state of competition in United States biologics markets, entry of follow-on biologics into these markets, and the effects such entry has had on biologics prices.The Essay’s main findings are that, as of March 23, 2020—exactly ten years since the signing of BPCIA into law—the FDA has approved a total of 26 follow-on biologics deemed biosimilar to 9 original products (ratio: 2.63 follow-on/original products), with only 16 of these deemed biosimilar to 7 original products (ratio: 1.78 follow-on/original products) actually available on the market. None of these follow-on products has been approved as interchangeable with their reference products, which means that substitution of the 7 original products with one of their 16 approved biosimilars cannot be done automatically. The price of these products was 10-37% lower than the price of the original biologic, with the average price savings being 24% or 27%. All 35 approved follow-on and reference products are owned by a total of 11 pharmaceutical companies. The number of years of market exclusivity of the 9 original biologics before the approval of the first biosimilar ranged between 13.5-28.92 with an average of 18.27 years or 15.33-29.42 with an average of 19.87 years before the launch of the first competing biosimilar.The Essay further puts forward a new method of measuring comparative levels of competition in drug markets by comparing the ratio of total approved follow-on products per total approved original products at certain critical benchmarks. Using this measurement tool, the Essay compares BPCIA’s track record with the levels of competition in small-molecule drugs before and after the Hatch-Waxman Act, showing that that BPCIA significantly underperforms in comparison and fails to instigate levels of competition that would lead to significant price drops and increase access to biologics in the United States. A short survey of the main likely reasons for BPCIA’s underperformance follows.The Essay concludes by presenting the following question: if BPCIA’s current track record is (still) not enough to convince that it is failing to meet its goals, what more would it take to reach such a conclusion and how much longer should policymakers wait before it is possible to surmise that BPCIA in its current form has failed to significantly increase access to biologics in the United State
Georgia’s Approach to Proportionality and Sanctions for the Spoliation of Electronically Stored Information
Get PDFThe rapid evolution and implementation of technology in society has resulted in the increasing use of data as evidence in court. While the scope of discovery is limited by, among other things, the burden imposed on the producing party, the sheer magnitude of electronic evidence compared to its physical counterpart necessitates a different framework for evaluating such a burden. Without limiting factors, the discoverability of electronically stored information (ESI) exposes producing parties to liability disproportionate to the value of a case. While the Federal Rules of Civil Procedure have evolved to address the discovery of ESI, the Georgia Civil Practice Act has remained largely stagnant, requiring judges to retrofit existing case law governing physical evidence to include ESI. This Note examines Georgia’s approach to the discovery of electronic evidence and proposes changes to modernize the state’s approach to eDiscovery
Chief Justice John Roberts: Institutionalist or Hubris-in-Chief?
No full textThe conventional wisdom among Supreme Court scholars and commentators is that Chief Justice John Roberts is an institutionalist who cares deeply about both his personal legacy and the Supreme Court’s prestige over time. This essay challenges that belief. While the Chief certainly cares about how the Court is perceived by the public, as do most of the justices, what most defines Roberts is his hubris—not a concern for the Court’s legitimacy or even his own place in history. Across the vast landscape of constitutional law, Roberts has distorted precedent and ignored text and history to further his own policy preferences. A master of the long game and the catchy sound bite, hubris, not institutionalism, most defines the Chief Justice of the United States
Against Discourse: Why Eliminating Racial Disparities Requires Radical Politics, Not More Discussion
Get PDFRacial disparity discourse is one of the main modalities through which we discuss and experience race and racism in the United States today—in discussions with colleagues and friends, in scholarly work, on cable news, on social media, and in lecture halls. Despite its ubiquity, racial disparity discourse is under-theorized: what, exactly, is its intended purpose? This Essay argues that most discussion about racial disparities is predicated on the faulty premise—grounded in the Habermasian concepts of discourse and communicative rationality—that antiracists will convince their interlocutors by engaging in a practice of rationalistic discourse among participants who share the objective and expectation of consensus. Drawing on the work of political philosopher Charles Mills and sociologists Pierre Bourdieu and Moon-Kie Jung, the Essay explains why the pragmatic conditions of possibility for discourse of this sort concerning matters related to race in the United States are frequently absent.
Specifically, Mills theorizes that a “racial contract,” saturated with racialized hierarchies and subordinating logics, has always underwritten the American social contract, leaving in its wake an “epistemology of ignorance” that is today responsible for localized and global cognitive dysfunctions. Jung develops Bourdieu’s concept of doxa to explain how, when it comes to the politics of race in the United States, individual agency and actions are always mediated by a classificatory, schematic, and hierarchical social structure in which race frequently plays a decisive organizing role. This Essay concludes by recommending that those committed to redressing vulnerability, precarity, and disposability along racialized lines should not focus their efforts on cobbling together a transracial coalition of the discursively convinced. Instead, it is argued that attentional and financial resources are better directed to develop and reinvigorate a radical, oppositional politics dedicated to eradicating racialized hierarchies and those elements of the political economy that reciprocally nurture and feed off them. Political theorist Chantal Mouffe’s model of “agonistic pluralism,” which centers the irreducibly conflictual nature of modern politics and proposes a politics that aims to confront and convert rather than to convince, is offered as a fruitful theoretical model to underwrite this non-discursive, radical politics
Introduction: Assuming a Critical Lens in Legal Studies: Reconciling Laws and Reality
No full textThe article focuses on intersectional approach to addressing pressing social and racial inequality in the areas of voter suppression, K–12 public schools, the U.S. criminal legal system, and housing insecurity. It mentions fundamental aspects of the lived experience condemn people and communities to realities marked by discrimination, limited prospects, disenfranchisement, violence by state and private actors, and racialized morbidity and mortality rates and interlocking inequality
