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Anne Marie Finley

Anne Marie Finley

Biotech Policy Group LLC, USA

Title: Pricing, public health, & politics: policy considerations for orphan products

Biography

Anne Marie Finley is the FDA Regulatory and Health Care Policy Strategist. She is the President of Biotech Policy Group, a consulting firm she founded in 2001 that focuses on development of products for rare diseases and unmet medical needs. She has more than 25 years’ experience in senior management positions at the Food and Drug Administration, US Department of Health and Human Services, the US Congress. She was named a top 50 Thought Leader in Orphan Drugs and Rare Diseases in 2014.

Abstract

Drug prices in the United States are higher than anywhere else in the world. Orphan products have long been perceived as pricier than many other drugs by payers, manufacturers and consumers. The Affordable Care Act’s expansion of insurance coverage and pharmaceutical benefits, along with a growing resistance to higher priced therapies, have added to the pharmaceutical pricing stress on the healthcare system and ultimately rare disease patients. Innovative responses to the current pharmaceutical pricing crisis have been developed by some drug companies, patient organizations, payers, regulators and legislators. The new Congress and new Administration have a number of options and opportunities by which to address pricing concerns in 2017.