Off-Label Promotion Can Increase Qui Tam Fraud Risk

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FDA News – Drug Industry Daily

Dec. 19 , 2003

By Lynn Stanton

Drugmakers promoting off-label uses of their products may inadvertently assist potential whistle-blowers with their cases and attract closer scrutiny from government investigators and courts, according to an expert in healthcare litigation.

Whistle-blower cases against pharma companies in the last couple of years have chiefly involved pricing issues and allegations of kickbacks in various forms. “But it is nice [from the whistle-blower’s point of view] if the drug or drugs at issue are being marketed for unlabeled uses and we can establish that those uses are of questionable efficacy,” attorney Kenneth Nolan told DID in an interview. “If you have that efficacy issue, or lack thereof, based on active marketing of unlabeled uses, it adds more fuel to the fire … and those types of situations are out there, unfortunately,” he added.

Nolan, whose Fort Lauderdale, Fla.-based law firm has recovered about $70 million for the federal treasury in qui tam cases, said he didn’t want to comment specifically on the whistle-blower case against Pfizer currently before the U.S. District Court in Boston, which involves allegations of off-label marketing (DID, Nov. 26, Page 3).

However, he said he did not agree “with the notion that just because a pharmaceutical company is marketing off-label that it is a false claim. I also will add that I think that the policy of allowing physicians to prescribe off-label, whether or not there is oversight by the FDA, is very sound.” But he suggested that future lawsuits could allege liability under the False Claims Act based on situations where the off-label indication is not supported by one of the major pharmaceutical compendia, as cited in the Medicaid drug rebate statute.

Nolan predicted that going forward, the kinds of cases whistle-blowers filed are likely to change because the pharma industry has done away with old practices cited in litigation over the past few years. “All the leading companies have significant compliance programs in place,” he said. However, he noted that there are likely many cases still stemming from illegal practices in the 1990s. “My personal guesstimate is that there are still many qui tam cases and government investigations that are currently private. I think that there are a lot of cases being filed that will be going forward, especially regarding kickbacks and pricing,” Nolan said.

Newer litigation is likely to involve honorarium payments, continuing medical education, free samples of injectables and clinical trials. “You’re going to see more creative schemes coming to light, [such as] falsification of research in order to obtain FDA approval,” Nolan said. – LS

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