Life Sciences

U.S. Government Leveraging Gilead To Shape Pharma Policy

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Following an 18-month-long investigation by the United States Senate Committee on Finance, Gilead’s pricing and marketing strategy for its hepatitis drugs, Sovaldi and Harvoni, was deemed one that chooses profit over patient access.

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In order to appropriately shape policy related to these findings, the Committee has written a letter to the healthcare and patient communities, requesting feedback on the implications of high-priced drugs. 

The letter, which is signed by U.S. senators Ron Wyden (D-OR) and Charles Grassley (R-IA), poses five questions to readers:

  • What are the effects of a breakthrough, single source innovator drug on the marketplace?
  • Do the payers in the programs have adequate information to know the cost, patient volume, and increases in efficacy of a new treatment regimen?
  • What role does the concept of “value” play in this debate, and how should an innovative therapy’s value be represented in its price?
  • What measures might improve price transparency for new higher-cost therapies while maintaining incentives for manufacturers to invest in new drug development?
  • What tools exist, or should exist, to address the impact of high cost drugs and corresponding access restrictions, particularly on low-income populations and state Medicaid programs?

While the letter criticizes Gilead, it asks respondents to be mindful of the financial investment that developing new drugs requires.

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