Texas AG sues Pfizer over quality-control lapses in kids' ADHD drug
In Nov. 20 story, adds comments from Pfizer and Tris in paragraphs 6-7, background in paragraph 8
By Brendan Pierson
Nov 20 (Reuters) -Texas Attorney General Ken Paxton accused Pfizer PFE.N 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 said in a statement that it had examined the allegations in the complaint on "multiple occasions" and "did not find any impact on the safety of the product." It said it believed the case had no merit and would move to dismiss it.
A spokesperson for Tris said in an email: "We categorically deny and intend to rigorously defend these allegations in the court of law."
Tris manufactured Quillivant for Pfizer until 2018, when it acquired the product from Pfizer.
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. Tris acquired the product in 2018.
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
Disclaimer: The XM Group entities provide execution-only service and access to our Online Trading Facility, permitting a person to view and/or use the content available on or via the website, is not intended to change or expand on this, nor does it change or expand on this. Such access and use are always subject to: (i) Terms and Conditions; (ii) Risk Warnings; and (iii) Full Disclaimer. Such content is therefore provided as no more than general information. Particularly, please be aware that the contents of our Online Trading Facility are neither a solicitation, nor an offer to enter any transactions on the financial markets. Trading on any financial market involves a significant level of risk to your capital.
All material published on our Online Trading Facility is intended for educational/informational purposes only, and does not contain – nor should it be considered as containing – financial, investment tax or trading advice and recommendations; or a record of our trading prices; or an offer of, or solicitation for, a transaction in any financial instruments; or unsolicited financial promotions to you.
Any third-party content, as well as content prepared by XM, such as: opinions, news, research, analyses, prices and other information or links to third-party sites contained on this website are provided on an “as-is” basis, as general market commentary, and do not constitute investment advice. To the extent that any content is construed as investment research, you must note and accept that the content was not intended to and has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such, it would be considered as marketing communication under the relevant laws and regulations. Please ensure that you have read and understood our Notification on Non-Independent Investment. Research and Risk Warning concerning the foregoing information, which can be accessed here.