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Doctors in legal trouble for billing for free drug samples

The case is a reminder that physicians should look closely at offers they receive from pharmaceutical companies.

By Tanya Albert, AMNews staff. July 14, 2003.

The federal government's investigation of AstraZeneca Pharmaceuticals' drug marketing and pricing practices not only netted a $355 million settlement from the company, it snared several physicians as well.

Two urologists -- Saad Antoun, MD, of Holmdel, N.J., and Stanley Hopkins, MD, of Boca Raton, Fla. -- pleaded guilty for their role in conspiring to bill for Zoladex samples they received for free. At press time, a third physician -- Robert Berkman, MD, of Columbus, Ohio -- was scheduled to enter a plea in court July 17.

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"Doctors shouldn't bill for samples," said Assistant U.S. Attorney Beth Moskow-Schnoll, who handled the criminal investigation and prosecution in the AstraZeneca case.

The physicians, who did not return phone calls for comment, have not been sentenced.

They face a maximum of five years in prison, a $250,000 fine and three years of supervised release.

Through its investigation, the government found that the physicians considered the samples as part of a discount for buying the medication from the company, Moskow-Schnoll said. For example, the physicians would pay $1,000 for eight boxes of the drug and get a ninth box for free.

"But the drugs they billed [government programs] for were clearly marked as samples, and they were being signed for as samples," Moskow-Schnoll said.

The charges against the physicians are part of a larger case against Wilmington, Del.-based AstraZeneca. In late June, the company pleaded guilty to conspiring to violate the Prescription Drug Marketing Act by providing free samples of Zoladex to urologists who then billed government health programs for the drugs between 1993 and 1996. As part of the plea agreement, the company will pay a nearly $64 million criminal fine, according to the Dept. of Justice.

AstraZeneca also reached a settlement, but did not admit liability, on civil charges. It will pay more than $266 million to settle allegations that it violated the False Claims Act by causing false and fraudulent claims to be filed with Medicare, TriCare and other government programs as a result of its drug prices, sales and marketing. The company will pay the federal government nearly $25 million to settle civil liabilities to Medicaid, according to the department.

The government alleged that between January 1991 and December 2002, the drug maker:

• Gave physicians free Zoladex samples knowing and expecting that some of the physicians would prescribe and administer them to their patients and then bill government programs for the drug.
• Offered some physicians free Zoladex, unrestricted education grants, consulting services, honoraria, travel and entertainment incentives, and business assistance grants and services in order to entice the doctors to buy the drug.
• Marketed a "return-to-practice" program, which involved inflating the average wholesale price that Medicare uses to set reimbursement rates for the drug, selling Zoladex to physicians for a deeply discounted price and then marketing Medicare reimbursements as additional profit for physicians.
• Misreported and underpaid Medicaid rebates for Zoladex.

"We accept responsibility for any improper sampling conduct that took place in the mid-1990s and have taken steps ... to prevent such activities from happening again," AstraZeneca said in a statement. "We have in place robust training, compliance and accountability policies for all employees, modeled on the government's guidance to the industry."

The case against AstraZeneca is similar to a case against TAP Pharmaceutical Products Inc. In October 2001, TAP agreed to pay $875 million to resolve civil and criminal charges related to its pricing and marketing of prostate cancer drug Lupron. Four physicians have pleaded guilty to charges in that case. Another physician is taking his case to trial.

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