Research

 

My legal research combines my experience as a healthcare attorney with my interest in how pharmaceutical manufacturers’ business strategies and practices influence the public’s access to healthcare. To date, my research has explored these practices in the following areas:

  • brand name manufacturers’ manipulation of citizen petitions to delay the entry of  generic drugs into the market;
  • pharmaceutical practices that exploit less robust informed consent protections afforded human subjects enrolled in clinical trials in developing countries;
  • FDA prohibitions on generic manufacturers to change inadequately labelled pharmaceutical products;
  • the effectiveness of the compulsory licenses under the DOHA Declaration in terms of developing countries access to essential medicines; and
  • economic and regulatory factors  influencing the current shortage in generic sterile injectables.

Interests

  • FDA regulatory approaches to ensuring generic drug safety and accessibility
  • Transformative negotiation and conflict resolution approaches for corporations, healthcare providers and healthcare institutions
  • Pedagogical approaches to negotiation and conflict resolution specifically tailored for corporate and healthcare settings
  • Effects of brand name and generic drug manufacturers’ business practices on drug prices, availability and safety

Works in Progress

  • Part I of this Article provides an overview of current drug shortages and their impact on patient care and healthcare providers. Part II offers an economic analysis of the root causes of the drug shortages. Specifically, Section A provides background on the manufacturers who produce many of the drugs in shortage. This section also examines how these drugs’ complex production processes affect manufacturers’ ability to meet increases in demand. Section B looks at unique features of the healthcare drug market and examines their influence on traditional notions of supply and demand. Section C explores the role market consolidations and healthcare reimbursement rates play in current shortages. This section also expands the analysis to examine how Group Purchasing Organizations’ (“GPOs”) contract practices influence generic manufacturers’ production decisions. Section D focuses on the FDA’s role in current shortages. According to the FDA, a leading cause of drug shortages is quality problems at manufacturing sites that precipitate production disruptionsThis section challenges that notion. After examining FDA policy decisions, this section posits that poor Agency execution has helped to transform manageable facility improvements into the current drug shortage. Part III analyzes current legislative, regulatory, and industry efforts to address drug shortages. While these approaches may mitigate shortages, this section concludes they do not go far enough. Part IV acknowledges that shortages will continue until it is profitable for generic manufacturers to maintain production levels sufficient to meet patient demand. Accordingly, this section offers a multi-pronged approach that balances patient needs, regulatory safeguards, and manufacturer incentives in a manner sufficient to end drug shortages.

  • The study that I am conducting with Dr. Chakravarti uses hypothetical scenarios that describe a clinical drug trial conducted by a fictitious company in a fictitious developing country. The scenarios incorporate various procedural violations sometimes observed during clinical trials. The scenarios manipulate the country of origin of the drug manufacturer (at 2 levels –US/China) and the drug trial participants (at 2 levels -adults/children). In addition, we manipulate what information is provided regarding the consequences of the trial (at 4 levels - none/number of participants harmed/ number of participants helped/number of participants both harmed and helped). The 2 x 2 x 4 design will be implemented between-subjects.