Former Indivior medical lead who pled guilty to false opioid marketing now seeks FDA hearing to escape debarment
Timothy Baxter, who was sentenced last December to six months home detention and fined $100,000 for sending false and misleading information on the opioid addiction drug Suboxone, is now seeking to debate the FDA’s proposal to debar him.
Baxter, the former medical director of Indivior, previously admitted that he failed to prevent Indivior from sending false and misleading information to the Massachusetts Medicaid program on the relative safety of a film version of Suboxone for children.
But now in response to the FDA’s proposal to debar Baxter for five years from working in the industry, Baxter’s lawyers are requesting a hearing on “disputed issues of material fact.”
For instance, Baxter’s lawyers say Baxter didn’t send the misleading information but was supervising someone who relayed the misleading information to the Massachusetts Medicaid program.
“Dr. Baxter’s conviction was not premised on the provision of misleading information about the ‘rate of unintended pediatric exposures to Suboxone Film’ – the misleading information pertained to other medications,” the lawyers wrote.
They also claim that the FDA and CDC have concluded that Suboxone Film is associated with a lower rate of pediatric exposure than comparable drugs.
But Elton Malone, assistant inspector general for investigations within HHS, said at the time of his sentencing, “Baxter’s knowing false and misleading representation of Suboxone is no small issue— especially at a time when our country battles the ongoing opioid crisis.”
In addition to the $1.4 billion resolution with Indivior’s former parent company, Reckitt Benckiser, from 2019, and a plea agreement with Indivior former CEO Shaun Thaxter, the total resolution relating to the marketing of Suboxone is more than $2 billion — the largest-ever resolution in a case brought by the Department of Justice involving an opioid drug.