Texas AG sues Pfizer over quality-control lapses in kids' ADHD drug
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[November 21, 2023]
By Brendan Pierson
(Reuters) - Texas Attorney General Ken Paxton accused Pfizer and its
supplier Tris Pharma of providing children's ADHD medicine that it knew
might be ineffective to the state's Medicaid insurance program for
low-income people, in a lawsuit unsealed on Monday.
The lawsuit, filed in Harrison County, Texas District Court, alleges
that Pfizer and Tris manipulated quality-control testing for the drug
Quillivant XR in order to obtain passing results from tests it was
required to perform under federal law between 2012 and 2018. Properly
done tests frequently showed that the drug failed to dissolve as it was
supposed to, a sign that it would not be released in the body as
expected, the lawsuit said.
The lawsuit also alleged that Pfizer, despite knowing of the
quality-control issues, persuaded Texas' Medicaid program to add
Quillivant to its list of preferred drugs.
Paxton alleged that many Texas families complained that Quillivant
failed to work.
"I am horrified by the dishonesty we uncovered in this investigation,"
Paxton, a Republican, said in a statement. The lawsuit accuses the
companies of defrauding the state's Medicaid program, and seeks
unspecified money damages from the companies.
Pfizer and Tris, which manufactured the drug for Pfizer, did not
immediately respond to a request for comment.
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Pfizer logo is seen in this illustration taken, May 1, 2022.
REUTERS/Dado Ruvic/Illustration/File Photo
The lawsuit stems from a
whistleblower complaint by Tarik Ahmed, who worked as Tris' head of
technology from 2013 to 2017.
Quillivant was developed by Nextwave Pharmaceuticals, a company
acquired by Pfizer in 2012. Like other drugs for attention
deficit/hyperactivity disorder, it has been plagued by shortages,
and never achieved a large national market share.
The U.S. Food and Drug Administration in 2017 warned Tris of
manufacturing lapses.
In its 2022 annual report, Pfizer said it had received a subpoena
from federal prosecutors in the Manhattan-based Southern District of
New York related to its relationship with Tris and the production of
Quillivant in 2018, but had not heard anything further after
responding.
(Reporting by Brendan Pierson in New York, Editing by Alexia
Garamfalvi and Matthew Lewis)
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