A US Attorney in Florida has filed federal lawsuits against a Jacksonville pharmacy and its parent company over allegations that the anti-psychotic medication Abilify (aripiprazole) was improperly added as an ingredient to a proprietary topical pain relief compound. The situation was brought to the government’s attention by an employee. The lawsuits were filed under whistleblower provisions under the federal False Claims Act (FCA).
Smart Pharmacy is what is known as a “compounding” pharmacy. These operations formulate and create “custom” medications for patients with special needs that cannot be addressed by commercially available products, based on their physician’s prescribing information. According to the complaint filed in the Middle District of Florida this past week, Smart Pharmacy added powdered Abilify pills to its proprietary pain creams in order to pad the invoices issued for reimbursement from federal health care programs, including Medicare Part D and Tricare, the program for active military personnel. The complaint also alleges that Smart Pharmacy routinely waived patient co-pays, regardless of whether or not such waivers were justified.
Speaking to local media, Assistant A.G. Jody Hunt said the purpose of the lawsuit is to hold companies accountable for gaming the system in order to “improperly enrich themselves at the taxpayers’ expense.” Hunt added, “Dispensing drugs for unproven uses and improperly waiving patient co-payments erodes public trust in the health-care system and increases the costs borne by federal health care programs.”
Beyond the alleged fraud, the practice of adding drugs such as Abilify to other medications for unapproved and unproven purposes poses a serious risk to patients. Abilify, approved by the FDA for the treatment of bipolar disorder, depression, and schizophrenia, as well as some forms of autism, has been targeted in mass litigation over its alleged side effects. Hundreds of lawsuits claim that the medication caused patients to engage in uncontrollable and self-destructive behaviors, including compulsive gambling and sex.
“Compounding” pharmacies make approximately 3 percent of the prescription formulations dispensed in the US today. Such operations have been at the center of serious controversy. In 2012, a product from a compounding pharmacy in Massachusetts put 13,000 patients in 23 states at risk for fungal meningitis due to on-site contamination of syringes.
An attorney for Smart Pharmacy has denied the allegations. In a media statement, parent company SP2’s corporate counsel Brian Dickerson said, “We look forward to having the opportunity to defend ourselves properly in court.” Attempting to reassure the general public in the face of the current allegations, Dickerson added, “Smart Pharmacy is a highly accredited compounding pharmacy in the local community and nationally. They have a full-time compliance team to ensure medications are received in a safe and compliant manner.”