Fort Worth-based Healthpoint Ltd. and DFB Pharmaceuticals will pay up to $48 million to settle allegations that Healthpoint improperly marketed a prescription skin ointment as eligible for reimbursement under the Medicare and Medicaid government health programs when it was not, the Justice Department announced Thursday.
Last year, federal regulators sued Healthpoint, saying its Xenaderm, used to treat bed sores, was never approved by the Food and Drug Administration as safe and effective. That rendered it ineligible for reimbursement, according to the lawsuit, which said government payments for Xenaderm topped $90 million.The company at the time said it would contest the lawsuit, saying it was based on a 1970 regulatory action on an unrelated product.Thursday, the Justice Department said Healthpoint agreed to pay $28 million, plus an additional $20 million "if there is a change in ownership of Healthpoint or DFB over the next three years."Healthpoint, part of DFB Pharmaceuticals, last week said it is being acquired by a British company for $782 million. Healthpoint officials did not return a telephone call Thursday seeking comment. The acquisition is expected to close by year's end.The Justice Department said the FDA in the 1970s found that Xenaderm's active ingredient was "less-than-effective for its intended use." But Healthpoint continued to represent Xenaderm as a prescription drug, which allowed nursing homes to be reimbursed for using it, the Justice Department said.The government said the Healthpoint settlement is part of a series of actions recovering more than $100 million from makers of unapproved drugs. It said the settlement does not determine liability on the part of Healthpoint.Jim Fuquay, 817-390-7552Twitter: @jimfuquayHave more to add? News tip? Tell us
