The U.S. Department of Justice (DOJ) is apparently investigating Nuplazid, the controversial Parkinson’s disease treatment sold by Acadia Pharmaceuticals.
According to a recent securities filing, Acadia received a Civil Investigation Demand last September for all documents and materials pertaining to Nuplazid marketing.
Federal prosecutors are apparently investigating Nuplazid pursuant to the False Claims Act. Such investigations usually begin after a private party files a whistleblower lawsuit alleging fraud against the federal government. Previous False Claims Act investigations have involved the payment of kickbacks to induce doctors to prescribe a medication, as well as the promotion of a prescription drug for unapproved, off-label uses.
So far, it’s not clear what aspects of Nuplazid marketing the DOJ might be probing. While Acadia is cooperating with federal prosecutors, its securities filing warned that “complying with the CID will require considerable resources and no assurance can be given as to the timing or outcome of the DOJ’s investigation.”
The U.S. Food & Drug Administration (FDA) approved Nuplazid nearly three years ago. In addition to being Acadia’s sole product, it is the only medication indicated to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
Because the FDA designated Nuplazid a “breakthrough therapy,” Acadia was able to obtain approval via a single, 6-week clinical trial involving just 200 patients. During that study, those taking Nuplazid had double the rate of deaths and other serious adverse events compared to those who received a placebo.
Within two years of its approval, the FDA had received 722 death reports involving Nuplazid, including more than 500 that listed it as the only suspect medication the patient was taking. According to CNN, hundreds of other Nuplazid reports involved falls, insomnia, nausea, and fatigue, while roughly 1,000 indicated patients had continued to experience hallucinations and delusions after they started treatment.
The FDA did take another look at Nuplazid, but ultimately attributed the reports to “older age, advanced Parkinson’s disease, and other medical conditions” typical of the patients prescribed the drug.
The Institute for Safe Medication Practices recently called the FDA’s reassurance “unwarranted”, after its own review suggested Nuplazid’s purported benefits do not outweigh its risks.
CNN’s earlier investigation also raised serious questions about Acadia’s Nuplazid marketing tactics.
The network found, for example, that roughly one-quarter of the 170 Medicare Part D physicians who had filed over 10 Nuplazid prescription claims in 2016 were listed as paid consultants for Acadia. Their scripts accounted for about about 10% of Medicare Part D’s Nuplazid reimbursments that year.
Acadia purportedly misclassified many of the physician payments reported to the government. After correcting the data, the company said fewer than 25% of the prescribers worked as paid consultants or speakers. However, the Acadia would not provide CNN with the specific payment information.
Twenty-six doctors received 6-figure payments (including financial compensation, free food, drink and travel) from Acadia n 2017. The highest-paid received over $200,000 that year.
Acadia told CNN that most of its 2016 and 2017 physician payments consisted of speaking fees to raise awareness about Nuplazid, and indicated that such payments decreased by 46% in 2018.
It’s not unusual for a pharmaceutical company to hire doctors as speakers and consultants when they launch a new drug, especially one aimed for a niche patient population. But Acadia’s outlays are surprisingly high, and could well become a focus of any Nuplazid investigation.
“That’s a huge amount of money to have that many people getting, and that huge amount of money is certainly something that would raise red flags,” Jacop Elbeg, former DOJ prosecutor and professor at Seton Hall University School of Law, told CNN.