Director, Health Law Institute
Associate Professor, Faculties of Medicine and Law
Placement: Yale University
Mentor: Amy Kapczynski, J.D., M.A., M.Phil. (Professor and Director, Global Health Justice Partnership, Yale Law School)
Project: De-Siloing Drug Regulation and Drug Coverage Processes to Realize Better Drug Value
Matthew Herder, J.S.M., LL.M., LL.B., is a 2017-18 Canadian Harkness/CFHIAssociate in Health Care Policy and Practice. He is currently the Director of the Health Law Institute at Dalhousie University in Halifax, Nova Scotia and is also an Associate Professor in the Dalhousie University Faculties of Medicine and Law. Herder’s research focuses on biomedical innovation policy, with a particular emphasis on intellectual property rights and the regulation of biopharmaceutical interventions. His work is often interdisciplinary and policy-oriented, and he has received grants from the Canadian Institutes of Health Research and the Royal Society of Canada, in addition to appearing as an expert witness before several Parliamentary committees on pharmaceutical regulation and policy. Prior to arriving at Dalhousie, Herder was the Ewing Marion Kauffman Foundation Legal Research Fellow at New York University’s School of Law. He was a Law Clerk at the Federal Court of Canada and was admitted to the Law Society of Upper Canada. Herder holds a Master of the Science of Law degree from Stanford Law School as well as two law degrees from Dalhousie University.
Project Abstract: Globally, the high prices of pharmaceutical drugs command a great deal of policy attention. In the United States alone, many have called for legislative reform, for example, to allow Medicare Part D to negotiate better drug prices. However, none of these policy proposals focus upstream, at the point when drugs are screened for lawful sale by the U.S. Food and Drug Administration (FDA). This is not surprising since the FDA reviews drugs for safety, efficacy, and quality and not for cost-effectiveness. The FDA is formally separate from the institutions involved in administering drug coverage (such as the Centers for Medicare & Medicaid Services), yet FDA regulation determines what drugs are on offer and how much is publicly known about them. Access to this information is critical to performance-based assessments of pharmaceutical pricing, particularly given that the FDA administers market-based protections that limit pharmaceutical companies’ ability to compete.
The core purpose of this research is to examine whether and how regulation of drugs by the FDA can facilitate or hinder efforts to achieve better drug prices in the U.S. Through qualitative case studies of two existing policy mechanisms, the extent to which the FDA may positively contribute to, or conversely, undermine, efforts to achieve pharmaceutical pricing control will be explored. The working theory being investigated is that ‘de-siloing’ the processes of drug regulation and drug coverage can help address the problem of high drug prices. While the details between the U.S. and Canada differ, this project aims to lay the groundwork for future research on how drug regulation and reimbursement processes can be better aligned in Canada to address the issue of high drug prices.