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Texas Settlement with Tris Pharma Over ADHD Drug Efficacy Claims

Tris PharmaceuticalsOctober 1, 2026Texas Attorney General

Penalty Amount

$7,500,000

Summary

Texas Attorney General Ken Paxton announced a $7.5 million settlement with Tris Pharmaceuticals over alleged misrepresentations about the efficacy of Dyanavel XR, an ADHD drug marketed for children. The release says the company overstated the drug’s efficacy and directed sales representatives to make misleading claims to doctors, including Medicaid providers.

Remedy

Tris Pharma is required to pay $7.5 million to Texas. No other remedies are specified in the press release.

Monetary Penalty

Contract Impact

Review pharmaceutical marketing, distribution, and sales-representative agreements for requirements that efficacy and comparative claims be supported by reliable evidence, approved before use, and consistent across sales calls and materials. Add or strengthen obligations for representative training, monitoring, recordkeeping, and cooperation with investigations, together with audit rights and indemnification for false or unsupported claims. For customer and healthcare-provider agreements, check that product representations and Medicaid-related certifications are accurate and appropriately limited; this release does not describe a privacy violation.

Contract Search Terms

claims substantiationproduct efficacy claimsmarketing materials approvalsales representative trainingMedicaid complianceaudit rightsregulatory cooperationindemnification for misrepresentation

Violation Types

Entity Details

Entity

Tris Pharmaceuticals

Industry

Healthcare

Official Sources

Source Evidence

Entity Name
"Tris Pharmaceuticals (“Tris Pharma”)"
Fine Amount
"requiring Tris Pharma to pay $7.5 million to Texas."
Violation description
"Tris Pharma overstated the drug’s efficacy and directed sales representatives to make misleading claims to doctors, including Texas Medicaid providers, that Dyanavel XR worked significantly faster than competing drugs and provided other unproven benefits to pediatric patients."
Event Date
"October 01, 2026 | Press Release"

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