Texas Attorney General Ken Paxton has filed a lawsuit against Pfizer and Tris Pharma, accusing them of defrauding the state and endangering children. Paxton alleges that the companies manipulated quality-test results from 2012 to 2018 to gain Medicaid reimbursement for Quillivant XR, a medication used to treat ADHD in children.
The lawsuit claims that Pfizer and Tris altered the drug’s testing method, violating federal and state laws, to ensure it passed regulatory requirements. Despite being aware of serious problems with Quillivant, the companies misrepresented its compliance with regulations to the Medicaid program. Consequently, thousands of Texas children received a “faulty schedule II controlled dangerous substance,” according to Paxton’s filing.
The whistleblower complaint by Tarik Ahmed, former head of technology at Tris from 2013 to 2017, brought attention to the alleged fraudulent practices. The U.S. Food and Drug Administration had previously warned Tris about manufacturing lapses in 2017, but the lawsuit suggests these events may be unrelated.
Many Texas families have also voiced concerns about the effectiveness of Quillivant. Paxton’s lawsuit seeks financial restitution for any benefits received by Pfizer and Tris as a result of their alleged violations, along with additional civil penalties.
While the outcome of this legal action remains uncertain, the case highlights the need for regulatory agencies to maintain confidence in manufacturers’ compliance with quality standards. It also emphasizes the importance of transparency and disclosure in ensuring the safety and efficacy of medications, particularly when it comes to vulnerable populations such as children.
FAQ
1. What is Quillivant XR?
Quillivant XR is a medication used to treat attention deficit hyperactivity disorder (ADHD) in children.
2. What are the allegations against Pfizer and Tris Pharma?
Texas Attorney General Ken Paxton has sued Pfizer and Tris Pharma for allegedly manipulating quality-test results to obtain Medicaid reimbursement for Quillivant XR and misrepresenting the drug’s compliance with regulations.
3. What penalties is Texas seeking in the lawsuit?
Texas is seeking monetary payments equal to the benefits received by Pfizer and Tris due to the alleged violations, as well as other civil penalties.
4. Why is this lawsuit significant?
This lawsuit draws attention to the importance of maintaining quality standards and transparency in the pharmaceutical industry to ensure the safety and efficacy of medications, particularly for vulnerable populations like children. It also highlights the role of regulatory agencies in monitoring compliance with regulations.