It has been just revealed that Pfizer is involved in a new scandal. Check out the latest reports about the lawsuit that the pharmaceutical company finds itself involved in.
Pfizer in the news again
Pfizer and one of its partners knowingly distributed a substandard medication for children with attention-deficit/hyperactivity disorder (ADHD), according to a legal action unsealed on November 20. The medication in question was Quillivant XR, which was approved by the U.S. Food and Drug Administration (FDA) in 2012.
It is also worth noting the fact that soon after its approval, the drug failed quality control tests. Despite this, Pfizer and Tris Pharma distributed the drug to children, fully aware of its adulteration. The lawsuit filed by Texas Attorney General Ken Paxton leaves no doubt that Pfizer and its partner were involved in the distribution of an adulterated drug to children, which is a serious violation of public health and safety.
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 is a medication that comes in powder form and needs to be mixed with water before use. It is a Schedule II controlled dangerous substance.
The FDA requires suppliers to display a black box warning about the potential abuse, dependence, and side effects of the medication, which include nausea, vomiting, and insomnia. The medication was developed by Nextwave Pharmaceuticals, and Pfizer acquired it in May 2012.
After a Tris report in 2012, it was discovered that the problems with the medication were due to the way it was being reconstituted.
Tris, the company responsible for the medication’s distribution, tried to solve the issue by retaining analysts to shake the mixture longer and only test it when no foaming was observed.
However, this did not solve the problem, 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 it gently with a spatula or glass rod for an additional minute.
The label of the drug as approved by the FDA only states that health professionals should shake the mixture for at least 10 seconds, without mentioning the use of sonication or any other steps. An email from Pfizer, obtained by Mr. Paxton, revealed that the change in the testing method rendered Tris “out of compliance.”
The attorney general was surprised that Tris approved the change and that Pfizer did not take any action to intervene, according to the lawsuit.
The lawsuit alleges that by concealing the information, Texas authorities approved the drug as a preferred medication for Medicaid, which Pfizer had targeted as a source of increased revenue.
