Pfizer and manufacturer Tris Pharma have agreed to hand over $41.5 million to lay to rest a 2023 lawsuit accusing the companies of knowingly providing compromised attention-deficit/hyperactivity disorder (ADHD) drugs to children through the Texas Medicaid program.
The allegations centered on Tris’ Quillivant XR, an extended-release liquid formulation of central nervous system stimulant methylphenidate, which Pfizer originally acquired through its $680 million NextWave Pharmaceuticals acquisition in 2012 before selling the franchise to Tris in 2018.
The lawsuit from the Texas Attorney General’s Civil Medicaid Fraud Division pointed fingers at Pfizer, Tris and Tris’ CEO and founder Ketan Mehta, and specifically accused Pfizer of distributing Quillivant to children on Medicaid despite knowing of the drug’s “pattern of failing quality control tests due to flawed manufacturing practices,” AG Ken Paxton explained in a release at the time.
The lawsuit went on to allege that Tris and Pfizer manipulated Quillivant testing to conceal the manufacturing issues and pass regulatory hurdles from 2012 to 2018, reaping the benefits of Medicaid reimbursement and running afoul of the Texas Health Care Program Fraud Prevention Act.
The complaint (PDF), which was triggered by a whistleblower—Tris’ former head of technology, Tarik Ahmed—laid out, in great detail, alleged manufacturing missteps and the purported complicity of executives, explaining that Tris, a smaller company, struggled to properly manufacture high quantities of the ADHD drug in question.
Early warning signs hinting at Tris' quality issues were teased in a 2011 Form 483 from the FDA and came to a head with an FDA warning letter in 2018, shortly after which Pfizer divested the product, the original lawsuit notes.
In the warning letter, the FDA took the unusual step of calling out Pfizer as well as its manufacturing partner, Tris. Pfizer had recalled multiple lots of the drug the previous year due to testing failures, according to the FDA citation.
Now, with the $41.5 million settlement, both companies have agreed to follow all state and federal laws related to drug manufacturing and distribution, according to a Nov. 19 press release from the Texas Attorney General's office.
“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,” Paxton commented in the release. “Under my watch, Big Pharma will not escape justice for lying about the effectiveness of its drugs.”
Pfizer, meanwhile, is “pleased to put this legacy matter behind us so that we can continue to focus on the needs of patients,” a company spokesperson said in an emailed statement. “Pfizer is deeply committed to the safety and well-being of the patients it serves and takes any allegations about the quality of its products very seriously."
A Tris Pharma spokesperson also confirmed the settlement, under which both Pfizer and Tris expressly deny “any and all liability and wrongdoing." The companies also said that they each examined the allegations detailed in the complaint and “did not find any impact on the safety of the product for patients.”
“We fully stand by the quality of our Quillivant, now and in the past, and the positive benefit it can have on patients,” the Tris representative added. “This agreement allows us to move forward and focus on our mission to deliver important medicines to improve patient health.”
Quilllivant XR earned $193 million in 2017 sales when it was still under Pfizer’s control, capturing a 0.9% share of the ADHD market in the fourth quarter before an end-of-year shortage, according to a regulatory filing. Pfizer has not been active in the ADHD space since the 2018 sale, while Tris is busy building up a next-gen pain relief drug prospect that it’s positioning as an opioid alternative.