Pfizer settlement Texas involves $41.5 million over allegations of altered testing methods for an ADHD drug.
• Pfizer and Tris settle for $41.5 million with Texas.
• Allegations involve altered testing methods for Quillivant XR.
• Settlement impacts Medicaid-covered children’s medication.
Background of the Settlement
Pfizer and Tris Pharma have agreed to a $41.5 million settlement with the state of Texas. This agreement resolves allegations that the companies altered testing methods for their ADHD medication, Quillivant XR, to meet regulatory standards. The lawsuit, filed by Texas Attorney General Ken Paxton, claimed that these practices violated both federal and state laws. The allegations centered on the period between 2012 and 2018, during which the companies allegedly misrepresented the drug’s compliance to Medicaid officials. More details can be found in the original report.
Allegations and Legal Proceedings
The lawsuit accused Pfizer of being aware of manufacturing issues with Quillivant XR, such as improper dissolution in the body. Despite this knowledge, the company allegedly assured state Medicaid officials of the drug’s compliance with legal standards. The legal proceedings highlighted complaints from families who reported that the medication was ineffective. Tris Pharma, responsible for manufacturing Quillivant XR for Pfizer, was also implicated in these allegations.
Impact on Patients and Market
The settlement is significant as it addresses concerns about the quality of medications provided to children on Medicaid. Quillivant XR is used to treat attention deficit hyperactivity disorder (ADHD) in children, a condition affecting millions in the United States. Ensuring the efficacy and safety of such medications is crucial for patient trust and public health. The case underscores the importance of rigorous testing and compliance in pharmaceutical manufacturing.
Regulatory and Industry Implications
This settlement may prompt increased scrutiny from regulatory bodies on pharmaceutical companies’ testing practices. It highlights the need for transparency and adherence to legal standards in drug manufacturing. The case also serves as a reminder of the potential legal and financial repercussions of non-compliance. As a result, other companies in the industry may review their practices to avoid similar issues.
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