Pfizer and Tris Pharma have agreed to pay $41.5m to settle allegations by Texas Attorney General Ken Paxton that they supplied adulterated attention-deficit hyperactivity disorder (ADHD) medication to children in the US state.

This is in breach of the Texas Health Care Program Fraud Prevention Act. 

The ADHD drugs case centred on the medication Quillivant XR, provided to children on Medicaid.

Paxton stated: “Pfizer and Tris Pharma provided adulterated drugs to children for years and changed test results in order to obtain the benefit of taxpayer-funded Medicaid reimbursement.

“Under my watch, Big Pharma will not escape justice for lying about the effectiveness of its drugs.”  

In November 2023, Paxton initiated legal proceedings against Pfizer and Tris Pharma.

The lawsuit claimed that the companies knowingly distributed Quillivant XR to Medicaid recipients, even though the medication failed quality control tests due to manufacturing issues, and that between 2012 and 2018, Pfizer and Tris Pharma allegedly modified the testing protocols of the drug, violating both federal and state regulations.

This alteration in testing methods was purportedly done to ensure that Quillivant XR met regulatory standards, allowing continued sales.

Pfizer and Tris Pharma have agreed to pay $41.5m and to comply with all relevant state and federal laws regarding drug manufacturing and distribution. The settlement requires the companies to adhere strictly to legal standards moving forward.

In 2018, Tris Pharma acquired NextWave Pharmaceuticals, Pfizer’s subsidiary, along with the two ADHD medications: Quillivant XR and QuilliChew ER.

Both are stimulants of the central nervous system approved for ADHD treatment.

Tris Pharma noted at that time that both products were jointly developed by NextWave and the company, using its LiquiXR platform.

Pfizer purchased NextWave in 2012. Tris continued to manufacture the treatments before and after approval by the US Food and Drug Administration.