Pharma firm to pay $39M civil fraud settlement over fluoride tablets

U.S. government agencies have announced a $39 million civil fraud settlement against a pharmaceutical company for selling half-strength fluoride supplements, according to a U.S. Department of Justice statement.

The U.S Attorney's Office for the Southern District of New York, the Office of Inspector General for the Department of Health and Human Services, and the New York office of the FBI have settled with Vintage Pharmaceuticals, doing business as Qualitest Pharmaceuticals; Vintage's parent company Endo Pharmaceuticals; and seven of their subsidiaries and affiliates in a civil fraud lawsuit. The settlement resolves federal claims under the False Claims Act that allege that Qualitest sold chewable fluoride tablets that contained less than half of the fluoride ion on the drug label, causing federal healthcare programs to be fraudulently billed for the tablets.

The lawsuit was initially filed in 2013 by whistleblower Stephan Porter, DMD, a Florida dentist who will receive $4.71 million under the False Claims Act's qui tam provisions. Qaulitest was alleged to have knowingly manufactured and sold understrength chewable fluoride tablets that were prescribed to children living in communities without fluoridated water to prevent tooth decay. Medicaid and the Federal Employees Health Benefits Program paid millions of dollars for the tablets, which the company stopped making and selling after the government investigation began.

The settlement includes $22.44 million to the federal government to resolve federal civil fraud claims and about $16.56 million to states to resolve state civil fraud claims.

As part of the settlement, Qualitest admitted that it manufactured and sold chewable fluoride tablets from 2007 to July 2013 and that it knew federal healthcare programs, including Medicaid, were a significant source of coverage of the fluoride tablets. The company admitted the drug labeling for the tablets said they contained 1.0 mg, 0.5 mg, and 0.25 mg of fluoride, but they actually contained less than half the appropriate amount of sodium fluoride recommended by ADA and American Academy of Pediatrics guidelines.