By Zachary Stieber
Pfizer and one of its partners distributed a medication to children despite having knowledge that the drug was adulterated, according to legal action unsealed on Nov. 20.
Pfizer and Tris Pharma distributed Quillivant XR, a drug for children aimed at treating attention-deficit/hyperactivity disorder (ADHD), even though the companies knew the drug did not meet federal standards, the lawsuit from Texas Attorney General Ken Paxton says.
The U.S. Food and Drug Administration (FDA) approved Quillivant in 2012 but soon after its approval, the drug failed quality control tests, according to the suit.
Instead of investigating the root cause, as required by federal rules, Tris repeatedly changed testing methods allegedly to try to generate positive results, Mr. Paxton’s probe found. Tris was “under financial pressure” to “rapidly increase production” and did ramp up production but “without adequate controls,” the suit states.
Quillivant comes in powder form and is reconstituted by pharmacists with water.
The medication is a schedule II controlled dangerous substance, and suppliers are required by the FDA to ensure display of a black box warning about abuse and dependence, and the potential side effects which include nausea, vomiting, and insomnia. It was developed by Nextwave Pharmaceuticals, and was acquired by Pfizer in May 2012.
After a Tris report in 2012 blamed the problems on sample reconstitution, Tris was said to retain its analysts to shake the mixture longer and only test when no foaming was observed.
Even that did not solve the issues, the suit alleges, prompting Tris to develop a new, unapproved testing method that involved letting the sample sit for 30 minutes after shaking and sonicate it with an ultrasound bath before mixing gently with a spatula or glass rod for an additional minute.
The FDA label on the drug only instructs pharmacists and other healthcare workers to shake the mixture vigorously for at least 10 seconds, with no mention of sonication or the other steps.
An internal Pfizer email obtained by Mr. Paxton said that the change in testing method meant that Tris was “out of compliance.” The attorney general was surprised that the change was approved by Tris, and that Pfizer took no actions to intervene, according to the suit.
Concealing the information resulted in Texas authorities approving the medication as a preferred drug for Medicaid, which Pfizer had targeted as a good way to increase revenue, Mr. Paxton says.
Consumers complained as early as 2013 of a “lack of effect” but when the companies discussed how to respond, they diverged, with Pfizer allegedly wanting to say the complaints stemmed from poor titration, according to the suit.
Tris was said to want to investigate the complaints but Pfizer told the FDA that the issue most likely was due to titration, even though an internal message said that “in the absence of conclusive data, it seems we are left with some hypothesizing.”
Pfizer’s response also blamed patients and caregivers for allegedly not handling the medication properly.
The FDA issued notices in 2014 and 2015 but Pfizer and Tris kept manufacturing the drug and distributing it. When the FDA identified violations of federal rules in 2017, Pfizer recalled some lots over testing failures.
Tris at that time advised Pfizer to hold all lots until the violations were addressed but Pfizer pushed Tris to keep the supply going, according to the suit.
The FDA said in a letter that the only testing method was the one the agency had approved, and specified that the other methods Tris had developed with extra shaking processes were unacceptable.
Despite the issues, Pfizer did not notify Texas authorities.
Another Pfizer email obtained by Mr. Paxton read, “I am getting less and less convinced we actually know how to make this product.”
Pfizer in 2018 sold the subsidiary that had developed Quillivant to Tris.
Tris that year said it learned the problems with the medication did stem from the unapproved testing methods.
Quillivant is also known as Methylphenidate, and is a stimulant. Stimulants used to treat ADHD have been increasingly prescribed to children and adults in recent years, with prescriptions rising particularly high during the COVID-19 pandemic, according to a March study.
Both Pfizer and Tris violated the Texas Medicaid Fraud Prevention Act, according to the suit.
Mr. Paxton is seeking a jury trial. He wants all payments made to the companies, and benefits they received as a result of the alleged illegal acts, to be given to Texas. Additional penalties such as relief of more than $1 million are also being requested.
The suit was filed on Nov. 8 in Harrison County court and unsealed on Monday.
Pfizer and Tris did not respond to requests for comment.
“I am horrified by the dishonesty we uncovered in this investigation,” Mr. Paxton, a Republican who recently survived an impeachment effort, said in a statement.
“Pfizer and Tris intentionally concealed and failed to disclose the issues with Quillivant to receive taxpayer funded benefits through Texas Medicaid, defrauding the state and endangering children. Our Civil Medicaid Fraud Division has done an outstanding job holding these pharmaceutical companies accountable.”