Dr. Friedman said he was willing to give the physicians in the Avastin case "the benefit of the doubt that their practice was looking for a source of drug that might be less expensive and is passing that on to their patients."
Noting that Avastin is "a really expensive drug" for which many patients do not have coverage, especially when it is being used off label, he added, "I don’t think the physicians should be held accountable at all. ... They had no reason to suspect, just based on the labeling that it really represented someone who was selling garbage."
The Label Tells the Tale
Labeling was an issue in the Missouri case. The U.S. attorney alleged that the physician purchased the prescription drugs from two codefendants employed by Ban Dune Marketing Inc., a business that was located in La Jolla, Calif. The products were not FDA-approved versions for use in the United States; their labeling did not contain National Drug Codes and other legally required information, according to the announcement.
"Some of the drugs contained foreign language labeling, for example Turkish language instructions. Further, these prescription drugs did not come from manufacturing plants that were registered with or inspected by FDA. As such, these prescription drugs were ‘misbranded’ and illegal to receive or provide to patients in the United States," the government said.
In all, the physician was accused of purchasing approximately $352,504 worth of prescription drugs from unlicensed foreign distributors through approximately 47 separate shipments containing 1,138 separate drug units at discounts ranging from 14%-60% of the average wholesale price.
"This indictment reflects the commitment of the FDA’s Office of Criminal Investigations to protect the American public from the harms inherent to misbranded and adulterated drugs. The public must have confidence that their health care providers are receiving and administering drugs that fully comply with U.S. laws," Special Agent in Charge Patrick J. Holland of FDA’s Office of Criminal Investigations, Kansas City Field Office, was quoted in the U.S. Attorney’s announcement.
Dr. Friedman has served as a consultant to and received grants from Genentech.