Texas AG sues Pfizer over quality-control lapses in kids’ ADHD drug By Reuters

By Brendan Pierson

(Reuters) – Texas Legal professional Common Ken Paxton accused Pfizer (NYSE:) and its provider Tris Pharma of offering kids’s ADHD medication that it knew may be ineffective to the state’s Medicaid insurance coverage program for low-income individuals, in a lawsuit unsealed on Monday.

The lawsuit, filed in Harrison County, Texas District Court docket, alleges that Pfizer and Tris manipulated quality-control testing for the drug Quillivant XR in an effort to acquire passing outcomes from checks it was required to carry out underneath federal legislation between 2012 and 2018. Correctly performed checks incessantly confirmed that the drug did not dissolve because it was speculated to, an indication that it could not be launched within the physique as anticipated, the lawsuit stated.

The lawsuit additionally alleged that Pfizer, regardless of understanding of the quality-control points, persuaded Texas’ Medicaid program so as to add Quillivant to its listing of most well-liked medication.

Paxton alleged that many Texas households complained that Quillivant did not work.

“I’m horrified by the dishonesty we uncovered on this investigation,” Paxton, a Republican, stated in an announcement. The lawsuit accuses the businesses of defrauding the state’s Medicaid program, and seeks unspecified cash damages from the businesses.

Pfizer and Tris, which manufactured the drug for Pfizer, didn’t instantly reply to a request for remark.

The lawsuit stems from a whistleblower grievance by Tarik Ahmed, who labored as Tris’ head of expertise from 2013 to 2017.

Quillivant was developed by Nextwave Prescribed drugs, an organization acquired by Pfizer in 2012. Like different medication for consideration deficit/hyperactivity dysfunction, it has been affected by shortages, and by no means achieved a big nationwide market share.

The U.S. Meals and Drug Administration in 2017 warned Tris of producing lapses.

In its 2022 annual report, Pfizer stated it had acquired a subpoena from federal prosecutors within the Manhattan-based Southern District of New York associated to its relationship with Tris and the manufacturing of Quillivant in 2018, however had not heard something additional after responding.