Texas Attorney General Ken Paxton filed a lawsuit against Pfizer, alleging the pharmaceutical giant “knowingly distributed” adulterated drugs to children.
Pfizer and Tris Pharma distributed the attention-deficit/hyperactivity disorder (ADHD) drug Quillivant XR to children, even though the drug did not meet federal standards.
“This illegal conduct caused Quillivant to be in violation of federal and state law, and rendered false Pfizer’s sworn certification of compliance to Texas Medicaid, which is required for drugs to be eligible for reimbursement under the Texas Medicaid program,” the lawsuit says.
“Defendants additionally misrepresented and concealed Quillivant’s status as an adulterated drug when providing public testimony before Texas Medicaid decision-makers,” it continues. “As a result, Pfizer and Tris obtained the benefit of virtually unfettered Medicaid reimbursements for Quillivant on the basis of fraudulent and unlawful misrepresentations and concealments, thereby violating the TMFPA,” or Texas Health Care Program Fraud Prevention Act.
The U.S. Food and Drug Administration (FDA) approved Quillivant in 2012, but the drug subsequently failed quality control tests.
“Beginning at least as early as October 2012, Tris quality control personnel observed that samples of Quillivant tested under FDA-required dissolution specifications were not generating passing results,” according to the lawsuit.
The lawsuit describes instances where Tris Pharma manipulated the drug’s testing to bypass regulations.
“Rather than thoroughly investigating the root cause of Quillivant’s failures as required by federal [Current Good Manufacturing Practice] regulations, Tris—under the direct orders of CEO Mehta—halted dissolution testing under the existing test method and focused on creating a new test under which its defective product could meet FDA criteria,” the filing says, adding, “Alarmingly, the new test method was not representative of real-world usage by patients, and worse, went against the pharmacy reconstitution instructions contained in the FDA-approved label for Quillivant.”
The filing notes that 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.'”
In a press release, Paxton said, “I am horrified by the dishonesty we uncovered in this investigation. 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.”