Request for Comments and Announcement of Public Workshop Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition #00004

Submission Number:
00004
Commenter:
Allison Davis
Organization:
University of Iowa College of Law
State:
Iowa
Initiative Name:
Request for Comments and Announcement of Public Workshop Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition
Matter Number:

P131208

Position: State biosimilar legislation creates a significant barrier to entry in the biosimilar market, is harmful to competition and is subsequently harmful to consumers. I have attached a formal paper that I have written weighing the arguments for and against state biosimilar legislation. This paper explores the interests that are at stake in state biosimilar legislation, the effect it has on consumers and other more reasonable regulatory options. I have no financial interest to disclose in regard to biosimilar legislation, the pharmaceutical industry, pharmacist associations or insurance companies and other payors. I am a second year law student at the University of Iowa College of law and a first year graduate student at the University of Iowa College of Public Health. This paper was written as part of my Food and Drug Law class under the supervision of Kevin Outterson, Professor of Health Law, Bioethics and Human Rights at Boston University School of Law. Professor Outterson holds a position as a visiting professor at the University of Iowa College of Law for the 2013-2014 academic year.