In addition, the settlements resolve allegations that ABC gave illegal kickbacks to physicians to convince them to buy Procrit in PFS rather than vials. Procrit is a treatment for patients suffering from anemia due to chronic kidney disease (CKD), HIV, or cancer.
Investigators found that Medical initiatives did operate as a pharmacy but instead as a repackager. It did not apply for a New Drug Application (NDA), a requirement of the U.S. Food and Drug Administration (FDA).
Additionally, Investigators found that Medical Initiatives failed to comply with pharmacy regulations in states where it has license to operate.
Medical Initiatives created, packed, and shipped pre-filled syringes (PFS) to oncologists and physicians treating cancer patients during chemotherapy. The pharmacy broke the FDA-approved drug vials, combined the drug from the vials, and repackaged them into smaller plastic syringes.
As a result, it created more PFS than the number of purchased vials. The practice is called “overfill,” which allowed the pharmacy to sell and profit from the excess PFS that often contained foreign matter.
