Texas Attorney General Ken Paxton has filed a new lawsuit against Pfizer and Tris Pharma. The lawsuit alleges that the two pharmaceutical companies defrauded Texas Medicaid and provided adulterated pharma drugs to children. Quillivant is an ADHD drug that was originally developed by NextWave Pharmaceuticals. Tris Pharma owned a 5% share in NextWave, which Pfizer acquired in May 2012.
After the acquisition, Pfizer agreed to pay Tris Pharma for product approval as well as a 25% royalty on all sales from the drug. In September 2012, the drug was approved by the FDA.
Quillivant is “an extended-release oral suspension methylphenidate” for the treatment of children with ADHD. Quillivant is a Schedule II Controlled Substance and carries a black box warning for abuse and dependence. Pharmacists combine the provided powder with water to reconstitute the drug, while caregivers are expected to shake the reconstituted drug before providing it to the child.
Quillivant commonly causes reactions, even when taken as directed, including insomnia, nausea, vomiting, anxiety, and tachycardia. Severe side effects can also occur when used as instructed. These side effects include cardiovascular reactions that can cause sudden death, psychiatric reactions, and long-term suppression of growth. If Quillivant is not taken at the proper dose, it can cause an overdose that would require emergency medical treatment.
The complaint further states, “Under the FDCA, it is illegal to adulterate a drug or to introduce into interstate commerce any drug that is adulterated. A drug becomes adulterated if ‘the methods used in, or the facilities or controls used for, its manufacture…do not conform to or are not operated or administered in conformity with current good manufacturing practice (CGMP).” CGMP is a minimum set of standards and “courts have broadly interpreted adulteration requirements, noting that ‘drugs produced in violation of CGMP regulations are deemed to be adulterated without the FDA having to show they are actually contaminated.”
According to the filing, Tris Pharma could not achieve consistency in manufacturing and failed mandatory quality control tests. The FDA issued a citation, and Tris agreed to correct the testing deficiencies. Tris Pharma later “concealed subsequent quality control test failures by manipulating the test process itself, in violation of federal and state laws and regulations.”
Pfizer knew that the sales of this drug depended on getting approval into the Texas Medicaid program. They lobbied and successfully got Quillivant added to a list of drugs reimbursable under Texas Medicaid in 2013. Pfizer was also able to obtain preferred placement for the drug in 2014. This enabled the Pfizer sales force to market Quillivant to Medicaid providers in Texas actively. All of this occurred despite their failure to update Texas Medicaid regarding the quality control measure failures. This is a direct violation of Texas law.
Dissolution testing is important to ensure the drug will be released into the patient’s body as expected. During this testing phase, Quillivant samples contained lumps after water was added to reconstitute the drug. Tris Pharma did not try to resolve this issue but instead retrained analysts to shake the mixture longer and only to test when “foaming is absent from the suspension.” Despite the new testing protocol, the testing still failed.
Tris Pharma CEO Mehta ordered that analysts stop testing with this method, which was producing failed results. They created a new, insufficient test that did not accurately represent real-world usage by patients. The method was also in direct opposition to the instructions provided to pharmacies to reconstitute the drug.
The new method required using a sonicator at maximum power for three minutes. A sonicator retails for over $1,000 and generates 40,000 pulses per second. Despite this new requirement to pass dissolution testing, the instructions for pharmacies were to “vigorously shake bottle for at least 10 seconds.” Ten seconds of vigorous handshaking is drastically different than 40,000 pulses per second for 180 seconds.
The FDA requires a submission for any change in substance, product, production, quality control, equipment, or facilities that “has a moderate potential to have an adverse effect on the identity, strength, quality, or potency of the drug.” This submission must be made at least 30 days before they can distribute any drugs that are produced with these changes.
The senior VP of quality objected to the CEO and stated that the testing method was not scientifically sound. At the same time, Pfizer was aware of the quality control issues and that the manufacturer had developed a new testing method. Texas Medicaid was not notified of the testing changes or difficulties. The complaint continues on for several pages detailing how the methods continued to adapt while Tris Pharma and Pfizer explained the problem as a “laboratory error” and that the analyst “erroneously sonicated samples” later in the testing process.
Several more methods were used to try to obtain more favorable test results. Pfizer indicated that the drug would need to be tested and re-released or recalled. However, Pfizer simply accepted that the problem was solved when the method 7 dissolution test was implemented. The lawsuit goes on to say that Tris Pharma failed to investigate or determine the root cause of the dissolution failures and instead changed the testing method multiple times in an attempt to pass the test.
This, says Texas, is the evidence that the ADHD drug Quillivant was adulterated, which is against federal and state law. The plaintiffs of the lawsuit are seeking monetary relief in excess of $1 million. That includes “two times the amount of any payments” provided under the Medicaid program and civil penalties between $5,500 and $11,000 for “each unlawful act committed by the defendants.”
Attorney General Paxton made the following comments in a press release about the investigation. “I am horrified by the dishonesty we uncovered in this investigation. Pfizer and Tris intentionally concealed and failed to disclose the issues with Quillivant receiving 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.”