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United States · Bill · S

S. 3335 (114th)

Fair Accountability and Innovative Research Drug Pricing Act of 2016

referredUnited States· United States Congress· EN

Introduced

15 September 2016

Last action

Status

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

Subjects

Discovery layer

Source updated

5 December 2025

Summary

Fair Accountability and Innovative Research Drug Pricing Act of 2016 This bill amends the Public Health Service Act to require manufacturers of certain drugs and biological products to report to the Department of Health and Human Services (HHS) price increases that result in a 10% or more increase in the price of a drug over a 12-month period. Reports are required for prescription drugs and drugs commonly administered in hospitals, except vaccines, drugs for rare conditions, and drugs with annual sales for Medicare and Medicaid enrollees of less than $1. Manufacturers that do not submit a required report are subject to a civil penalty. The Inspector General of HHS must review drug price information to determine compliance. Collected penalty funds must be used to carry out activities related to this reporting requirement and to improve consumer and provider information about drug value and drug price transparency. HHS must publish manufacturer reports, a summary of those reports, and supporting analyses.

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3 official files

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