Pfizer and one of its partners distributed a medication to children while knowing that the drug was adulterated, according to legal action unsealed on Nov. 20.
Pfizer and Tris Pharma distributed Quillivant XR, a drug for children with attention-deficit/hyperactivity disorder (ADHD), even though the companies knew the drug didn’t 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 the 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 didn’t 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 sonicating 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 health care workers to shake the mixture vigorously for at least 10 seconds, with no mention of sonication or the other steps.