Manufacturing Barriers to Biologics Competition and Innovation

As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA regulation, not only creates high barriers to entry of indefinite duration but also undermines efforts to advance fundamental knowledge. In sharp contrast, offering incentives for information disclosure to originator manufacturers would leverage the existing interaction of trade secrecy and the regulatory state in a positive direction. Although trade secrecy, particularly in complex areas like biologics manufacturing, often involves tacit knowledge that is difficult to codify and thus transfer, in this case regulatory requirements that originator manufacturers submit manufacturing details have already codified the relevant tacit knowledge. Incentivizing disclosure of these regulatory submissions would not only spur competition but it would provide a rich source of information upon which additional research, including fundamental research into the science of manufacturing, could build. In addition to provide fresh diagnosis and prescription in the specific area of biologics, the Article contributes to more general scholarship on trade secrecy and tacit knowledge. Prior scholarship has neglected the extent to which regulation can turn tacit knowledge not only into codified knowledge but into precisely the type of codified knowledge that is most likely to be useful and accurate. The Article also draws a link to the literature on adaptive regulation, arguing that greater regulatory flexibility is necessary and that more fundamental knowledge should spur flexibility. A vastly shortened version of the central argument that manufacturing trade secrecy hampers biosimilar development was published at 348 Science 188 (2015), available online

Keeping Tabs on Financial Innovation: Product Identifiers in Consumer Financial Regulation

The financial crisis of 2008 gave rise to renewed discussion about whether financial innovations should undergo higher scrutiny for potential harm and, if so, what type? In this Article, the authors propose a new system for monitoring financial innovations through a system of registration, data collection and analysis using unique product identifiers. Creating product identifiers would increase monitoring abilities substantially at relatively low cost by facilitating the linkage of separate databases. The assignment of unique product identifiers would also minimize errors in the identification and classification of different financial products. These identifiers would be available to both the government and the public to harness outside analysis by independent researchers in order to improve the monitoring of financial risk

Adverse Drug Reactions: Harnessing Experiential Data to Promote Patient Welfare

Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA\u27s spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of postapproval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization and more substantial structural reforms in order to avoid a troubling replay of recent prescription drug withdrawals. The proposed reforms may help to enhance a physician\u27s ability to provide quality patient care based on optimal knowledge of the safety and efficacy of pharmaceutical products

Platitudes about Product Stewardship in Torts: Continuing Drug Research and Education

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry\u27s exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation of product stewardship ). Frustrated by the inherent limitations of preapproval clinical trials, the failure of the Food and Drug Administration (FDA) to demand rigorous postapproval testing, and the minimal information communicated directly to patients, these commentators have urged judges to draw on the common law tradition in order to remedy these and other alleged failings of the regulatory system

Is Germline Gene Editing Exceptional?

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a line that humans should not cross. This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs to be regulated, whether it can be regulated under existing law. Ultimately, this Article finds that germline gene editing should and can be regulated under existing law; however, the current federal-centric regime is not the optimal way to regulate this subset of gene editing. Instead, this Article argues that germline gene editing should be regulated like traditional assisted reproductive technology, such as in vitro fertilization, instead of as an exceptional, federally-regulated medical product. Doing so would reduce regulatory barriers in access to innovation, and the technique would be subject to a significantly less burdensome and less federally dominated regime than it is today. Additionally, this Article\u27s proposed regulatory treatment of germline gene editing would increase access to the technique and remove the federal government, which is prone to regulate based on social and political views,from the practice of medicine, in order to allow access to a procedure that could improve or save many lives