Research
Selected Research
The Propagation of FDA Regulatory Enforcement Through Drug Supply Chains (Job Market Paper)
Abstract: The Food and Drug Administration (FDA) upholds the safety of US drug supply, but persistent shortages and concentration in manufacturing have raised concerns that the agency’s regulatory enforcement actions may disrupt access to essential medicines. I study this trade-off between access and safety by estimating the causal effects of FDA enforcement at upstream drug manufacturing facilities on downstream hospitals and the patients they serve. Linking Medicare claims to newly assembled data on the origin facilities of sterile injectable opioid drugs, I find that enforcement causes substantial production disruptions, reducing volume from the implicated facility by one-third. Yet, responses by other elements of the supply chain provide resilience: hospitals draw on multi-sourced procurement networks to rapidly substitute to alternative suppliers, such that more-exposed hospitals experience no detectable declines in drug supply relative to less-exposed hospitals. Even in high-risk conditions under which supply does decline—among rural hospitals and when enforcement occurs during critical shortages—the disruption does not compromise patient health or quality of care. These findings suggest that, despite concerns about fragility in this setting, FDA enforcement in concentrated supply chains shields patients from drugs produced at non-compliant facilities while maintaining access and quality of care.
Healthcare Consequences of Drug Quality Failures: Evidence from the 2012 NECC Outbreak (Draft)
Abstract: This paper studies the healthcare consequences of patient exposure to drugs with severe quality failures. I examine the shipment of contaminated sterile injectable drugs produced by the New England Compounding Center (NECC) in 2012, which triggered the largest known outbreak of disease due to drug contamination in U.S. history. Using administrative Medicare claims and NECC invoice records, I implement a difference-in-differences design to compare the outcomes of injections administered by healthcare providers that did and did not receive the implicated drugs. Potential patient exposure to the implicated drugs caused substantial changes in downstream care, including a 72 percent increase in hospital-based and post-acute care and a 25 percent increase in total healthcare spending in the 180 days after injection. The effects are consistent with both curative treatment of contamination-related illness and precautionary responses to exposure risk. I also find that changes in patterns of care emerged sharply when public health authorities announced the outbreak and issued treatment guidance, highlighting the role of centralized public health communication in raising awareness of drug quality failures and coordinating the downstream clinical responses to them.
How Does Outsourcing Affect Hospital Drug Access and Quality of Care? Evidence from Compounded Sterile Injectables
- What happens when hospitals substitute between sterile injectable drugs prepared in-house and outsourced to large-scale drug compounding facilities, which emerged as a new type of hospital supplier in the early 2000s? Using policy action responding to concerns about the safety of outsourced drug compounders, which operate outside of the full FDA regulatory regime, I estimate the causal effects of outsourcing on patient quality of care and hospital staffing and financial outcomes.
A Telehealth Post-Emergency Department Transition of Care Program: A Value-Based Innovation that Integrates Emergency Department Visits into the Care Continuum (Published in Western Journal of Emergency Medicine: Link)
- Evaluation of UCSD’s Hospital to Home program on ED revisits and PCP office visits
- With: Allyson Kreshak, Itzik Fadlon, Vaishal Tolia, Lindsey Pierce, Parag Agnihotri, Brian Kwan, Eric Williamson, Jeffrey Mueller, Ming Tai-Seale