Back to Agenda
Public and Regulatory Response To Drug Pricing Concerns
Session Chair(s)
Nielsen Hobbs
Executive Editor
The Pink Sheet, United States
Stakeholders agree that generics are an effective approach to lowering drug prices, but approvals are often challenging for sponsors to obtain, and the cheap prices that consumers value make it hard for sponsors to stay on the market. This session will describe the strategies that regulators and payers are using to combat those problems. FDA does not regulate the price of drugs, but the regulatory decisions it makes can nevertheless impact them. For generics, that can mean setting a high bar or a low bar for equivalence and deciding which kinds of products are eligible for accelerated review or additional interactions with the agency. Likewise, payers don’t control the application process, but their decisions go a long way to determining which products are developed. This session will analyze the regulatory strategies that can eventually prove successful, explain how companies and policymakers can best handle the development of complex generics, and discuss new steps payers are making to ensure generic sponsors have a market for the products after a long development process.
Learning Objective : Identify the steps for successfully developing a complex generic product; Describe new reimbursement approaches being used to encourage a stable generic market; Discuss review pathway selection at the US FDA's Office of Generic Drugs; Recognize product categories where FDA is encouraging generic applications.
Speaker(s)
Panelist
Jan Burkett, MBA, RPh
Express Scripts, United States
Vice President, Drug Sourcing Officer
Panelist
Heather Wall, MBA
Civica Rx, United States
Chief Commercial Officer
Panelist
Adam Kroetsch
Duke-Margolis Center For Health Policy, United States
Research Director, Biomedical Information and Regulatory Policy
Have an account?