# Pharmaceutical Manufacturer Kickback Resolutions and Associated Financial Penalties, 2000-2025

**Authors:** Tobias Liu, Joseph S. Ross, Christopher J. Morten
**Citation:** "Pharmaceutical Manufacturer Kickback Resolutions and Associated Financial Penalties, 2000-2025," 9 *Journal of the American Medical Association Network Open*, no. 3, Art. e261735, 2026, at 1 (with Tobias Liu, Joseph S. Ross and Reshma Ramachandran)
**Source:** http://doi.org/10.1001/jamanetworkopen.2026.1735

## Introduction

*p. 1*
The Anti-Kickback Statute (AKS) prohibits pharmaceutical manufacturers from providing payments or other incentives to physicians, pharmacies, or other health care entities to induce or reward prescribing items or services reimbursed by federal health programs. 1 Prior studies suggest that kickbacks influence prescribing, leading to excess spending and inappropriate treatment. 2 Financial penalties, including fines and settlement payments, are intended to deter such misconduct, but industry kickbacks persist. 3 We examined the size of financial penalties levied by the US government on pharmaceutical companies between 2000 and 2025 and associated outcomes.

## Methods

*p. 1*
This cross-sectional study followed the STROBE reporting guideline. In accordance with the Common Rule, it was exempt from ethics review and informed consent because it used publicly available information. We searched press releases posted on the US Department of Justice website between January 1, 2000, and June 1, 2025, to identify resolved cases alleging AKS violations by pharmaceutical manufacturers. We excluded cases without dates, involving medical device manufacturers, and where price fixing was the only violation. We extracted company name, alleged conduct duration, implicated drugs, and kickback-relevant penalty amount from press releases. For cases involving multiple violations that did not separate out kickback-specific penalties, we used the full penalty amount. We presumed that kickbacks occurred throughout the entire alleged violation period. Key drug and settlement characteristics were also extracted (eMethods in Supplement 1).

*p. 1*
We then reviewed company 10-K and 20-F forms to identify implicated drug US revenue during the alleged violation period. For years missing revenue data, we estimated values by finding the mean of available revenues; cases with no revenue data were excluded. All penalty amounts and

## Results

*p. 1*
Among 64 cases meeting inclusion criteria, kickback violations resolved through civil settlements in 53 (82.8%), criminal settlements in 2 (3.1%), both in 9 (14.1%), and judicial judgment of liability in 0 cases. Thirty cases (46.9%) involved multiple drugs, and corporate integrity agreements accompanied 30 cases (46.9%); 11 companies resolved multiple settlements, including 4 Novartis settlements. The median (IQR) time from alleged misconduct to settlement was 3.8 (2.6-7.0) years.

*p. 1*
Across 142 implicated drugs, 105 (73.9%) had complete revenue data, including 49 (46.7%) blockbusters. Among those with complete revenue data, the median (IQR) US revenue per drug during the alleged violation period was $2 091 773 260 ($674 693 333-$4 827 508 333]).

## + Supplemental content

*p. 1*
Author affiliations and article information are listed at the end of this article.

## Discussion

*p. 2*
This cross-sectional study found that pharmaceutical manufacturers penalized for kickbacks paid only 2.2% of US revenue accrued from selling implicated drugs during years of alleged violations.

*p. 2*
Alleged conduct commonly involved direct payments to physicians intended to induce prescriptions of federally reimbursed drugs. Criminal AKS cases were uncommon, likely because they are more

## Footnotes

> JAMA Network Open. 2026;9(3):e261735. doi:10.1001/jamanetworkopen.2026.1735 (Reprinted) March 13, 2026 4/4 Downloaded from jamanetwork. com by guest on 08/ 11/ 2026