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Tuesday, June 25 • 4:15pm - 5:30pm
#299: Public and Regulatory Response To Drug Pricing Concerns

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-638-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Nielsen Hobbs


Jan Burkett, MBA, RPh

Heather Wall, MBA

Adam Kroetsch

avatar for Jan Burkett

Jan Burkett

Vice President, Drug Sourcing Officer, Express Scripts
Jan is a pharmacist with diverse experience in pharmacy benefit management, contracting and joint venture strategy. She joined Express Scripts in 1993 and is currently VP, Chief Drug Sourcing Officer, responsible for Express Scripts' drug sourcing procurement and strategy. Jan leads... Read More →
avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clinical Professor, Duke-Margolis Center For Health Policy
Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. He directs the DC-based office of the Center leading its pharmaceutical and medical device policy portfolio, and... Read More →
avatar for Nielsen Hobbs

Nielsen Hobbs

Executive Editor, US Policy and Regulatory, The Pink Sheet/Scrip
Nielsen Hobbs has more than 20 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining the “The Pink Sheet” he worked for Congressional Quarterly. Hobbs enjoys discussing... Read More →
avatar for Heather Wall

Heather Wall

Chief Commercial Officer, Civica Rx
Heather’s expertise spans the healthcare continuum focusing on design, implementation and execution of hospital & health system strategies to improve patient care. Heather has a 20+ year career where she has had accountability for strategy, operations, finance & high-value health... Read More →

Adam Kroetsch

Research Director, Duke-Margolis Center For Health Policy

Tuesday June 25, 2019 4:15pm - 5:30pm PDT
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  12: Value-Access, Forum |   09: Regulatory, Forum