Texas Attorney General Ken Paxton has filed a lawsuit against Pfizer for knowingly distributing adulterated drugs to children.
Legal action disclosed on Nov. 20 states that Pfizer and one of its partners distributed a drug to youngsters knowing it was contaminated.
Texas Attorney General Ken Paxton’s lawsuit claims that Pfizer and Tris Pharma supplied Quillivant XR, a medication for children with attention deficit/hyperactivity disorder (ADHD), while knowing the medication did not fulfill federal criteria.
Quillivant was approved by the US Food and Drug Administration (FDA) in 2012; however, the lawsuit claims that the medication failed quality control testing shortly after the FDA gave its clearance.
Mr. Paxton’s investigation revealed that Tris frequently altered testing procedures, purportedly in an attempt to get good findings, rather than looking into the underlying cause as mandated by federal regulations. The lawsuit claims that Tris increased production “without adequate controls” despite being “under financial pressure” to do so “rapidly.”
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Pharmacists dilute Quillivant, which is sold in powder form, with water.
As a Schedule II regulated hazardous substance, the drug must be displayed with a black box warning about abuse and dependency as well as potential adverse effects such nausea, vomiting, and insomnia, as mandated by the FDA. Nextwave Pharmaceuticals created it, and in May 2012, Pfizer purchased it.
Tris was reported to have kept its analysts longer to shake the combination and only tested after no foaming was noticed following a 2012 study that attributed the issues to sample reconstitution.
According to the lawsuit, even that was unable to resolve the problems, so Tris created a novel, unauthorized testing procedure that entailed sonicating and shaking the sample with an ultrasound bath for half an hour before gently mixing it with a spatula or glass rod for an extra minute.
The FDA label for the medication makes no mention of sonication or the other procedures; it simply tells chemists and other medical professionals to shake the mixture vigorously for at least 10 seconds.
According to an internal Pfizer communication that Mr. Paxton was able to receive, Tris was “out of compliance” due to the modification in the testing procedure. According to the lawsuit, the attorney general was taken aback by Tris’ approval of the modification and Pfizer’s lack of intervention.
According to Mr. Paxton, Pfizer saw hiding the information as a smart strategy to boost sales, as it led to Texas authorities authorizing the prescription as a preferred drug for Medicaid.
Customers began complaining about a “lack of effect” as early as 2013, but as the firms debated how to reply, Pfizer allegedly wanted to claim that the issues were caused by inadequate titration, according to the lawsuit.
Pfizer informed the FDA that the problem was probably caused by titration, despite the fact that an internal memo stated that “in the absence of conclusive data, it seems we are left with some hypothesizing.” Tris was rumored to want to look into the complaints.
Molecular virologist David Speicher revealed in his recent bombshell study that he found billions of DNA fragments in the COVID vaccine.
In their statement, Pfizer also accused carers and patients of improperly handling the drug.
Despite warnings from the FDA in 2014 and 2015, Pfizer and Tris continued to produce and market the medication. Pfizer recalled certain lots due to testing failures in 2017 after the FDA found violations of federal regulations.
According to the lawsuit, Tris urged Pfizer to continue the delivery even though Tris had instructed Pfizer to suspend all lots until the violations were fixed at that point.
In a letter, the FDA stated that the only testing procedure that was permissible was the one that the agency had approved. Tris’s other methods, which involved additional shaking processes, were deemed inappropriate.
Pfizer failed to alert Texas authorities despite the problems.
Mr. Paxton was able to receive another email from Pfizer that stated, “I am becoming less and less confident that we actually know how to make this product.”
2018 saw Pfizer sell Quillivant’s development subsidiary to Tris.
That year, Tris reported that it discovered the medication’s issues were indeed caused by improper testing procedures.
Methylphenidate, or quillivant, is a stimulant. Children and adults have been prescribed more stimulants to manage ADHD in recent years; during the COVID-19 pandemic, prescriptions increased even more, according to a March research.
The lawsuit claims that Pfizer and Tris both broke the Texas Medicaid Fraud Prevention Act.
Mr. Paxton is requesting a trial by jury. He demands that Texas receive any money paid to the businesses and any benefits they obtained as a result of the alleged criminal activities. More fines, like relief exceeding $1 million, are also being asked for.
The lawsuit was unsealed on November 20 after being filed in Harrison County court on November 8.
Requests for comments from Tris and Pfizer were not answered.
“I am horrified by the dishonesty we uncovered in this investigation,” Mr. Paxton, a Republican, 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.”