According to the St. John Medical Center website, Massouh practices oncology, hematology and internal medicine. A representative at Massouh's office said they had no comment.
Also charged are Ranjan Bhandari, 56, Liverpool. Timmappa Bidari, 68, Parma. David Fishman, 62, Euclid; Su-Chiao Kuo, 60, Brunswick; Poornanand Palaparty, 62, Cleveland; and Hassan Tahsildar, 55, of Euclid.
The doctors are accused of obtaining drugs, including Zometa, Kytril, Taxotere, Gemzar, Eloxatin and others, from outside the United States, where the drugs were not approved by the FDA, according to the charges. “These doctors used drugs that had not been approved by the FDA,” Dettelbach said in a press release. “Our office is committed to working with our partners to make sure patients are getting medicine that has been properly inspected.”
A special agent assigned to the case said safety was an issue.
“FDA’s regulatory standards are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers,” Antoinette V. Henry, Special Agent in Charge, FDA’s Office of Criminal Investigations, said. “We will continue to work to investigate all persons, including medical professionals, who disregard regulatory requirements and jeopardize the public health by participating in the distribution of misbranded products.”
A drug may be considered misbranded even if it is identical in composition to an FDA-approved drug (that is, a drug labeled and packaged in compliance with the FDA’s standards) and even if it was made by the same manufacturer in the same facility as the FDA-approved version.