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DIA 2019 Global Annual Meeting

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Public and Regulatory Response To Drug Pricing Concerns

Session Chair(s)

Nielsen  Hobbs

Nielsen Hobbs

  • Executive Editor, US Policy and Regulatory
  • The Pink Sheet/Scrip, 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.


Jan  Burkett, MBA, RPh


Jan Burkett, MBA, RPh

  • Vice President, Drug Sourcing Officer
  • Express Scripts, United States
Heather  Wall, MBA


Heather Wall, MBA

  • Chief Commercial Officer
  • Civica Rx, United States
Adam  Kroetsch


Adam Kroetsch

  • Research Director
  • Duke-Margolis Center For Health Policy, United States