Doctor Gave Patients Unapproved Drugs And Profited Off Them: FDA

A Garden City ophthalmologist admitted to giving patients drugs that he had purchased overseas and were not approved for use in the United States.

Dr. Mark Fleckner, who lived and worked in Garden City, settled civil fraud claims with the government in which he admitted to using aflibercept (“Eylea”) and ranibizumab (“Lucentis”) to treat patients who had wet, age-related macular degeneration or other diseases and conditions of the eye. Because the drugs were not approved by the FDA, they were not eligible for reiumbursement by Medicare, but Fleckner still submitted claims and received money fraudulently. As part of the agreement, Fleckner will pay $6,955,240.80.

“Dr. Fleckner bypassed the FDA’s regulatory authority by purchasing and administering unapproved pharmaceutical products in violation of Medicare regulations,” said United States Attorney Richard Donoghue. “The settlement holds Dr. Fleckner accountable for his actions and ensures that Medicare funds will only be used for FDA-approved pharmaceuticals.”

According to Donoghue, from July 1, 2014 through June 27, 2017, Fleckner purchased the drugs because they were less expensive than those that were approved by the FDA for sale in the US. Medicare reimburses physician-administered drugs at a set rate based on the average sales price of the drug in the United States. By purchasing cheaper drugs in other countries, Fleckner was able to profit from the reimbursements he received from Medicare.

“FDA’s oversight of prescription drugs protects consumers from illicit medicines obtained from unauthorized foreign sources,” FDA-OCI Special Agent-in-Charge Jeffery Ebersole said. “We will continue to pursue and bring to justice those who place profits over their patients’ safety.”

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