WASHINGTON (AP) – Federal regulators alleged Tuesday that an Illinois-based company bought the only two medicines approved to treat premature babies born with a potentially life-threatening congenital heart defect, and then increased prices nearly 1,300 percent.

The Federal Trade Commission said in a civil lawsuit that Ovation Pharmaceuticals Inc., illegally maintained a monopoly in drug treatments for the heart defect. The commission seeks to prevent Ovation from maintaining simultaneous interest in the two drugs – NeoProfen and Indocin. Also, it seeks forfeiture of all unlawfully obtained profits.

The commission said Ovation purchased the rights to Indocin in August 2005 and then acquired the rights to NeoProfen five months later. It set the price for the two medicines at about $500. Before the second acquisition, Indocin was priced at $36.

An estimated 30,000 babies are treated with the drugs each year.

“Ovation’s profiteering on the backs of critically ill premature babies is not only immoral, it is illegal,” said FTC Commissioner Jon Leibowitz in a statement issued separately from the lawsuit.

Ovation Pharmaceuticals Inc., based in Deerfield, Ill., rejected the commission’s allegations. It said NeoProfen is superior to Indocin, and is not interchangeable for most premature infants with the heart defect.

The company “welcomes the opportunity to demonstrate in court in Minneapolis that the FTC’s allegations and claims are without merit,” Ovation said in a prepared statement.

The FTC said the only alternative to treating the heart defect, known as patent ductus arteriosus, is surgery, but that option carries a risk of serious complications and costs far more than treatment with drugs.

“As a result, hospitals have little choice but to pay Ovation’s monopoly price,” the commission said in the lawsuit. “The artificially high prices that hospitals are forced to pay ultimately raise costs for families, tax-supported programs such as Medicaid, and other public and private purchasers.”

Indocin was approved by the Food and Drug Administration to treat the heart defect in infants in 1985. Ovation purchased the rights to Indocin from Merck and Co. Merck agreed to manufacture the drug and supply it to Ovation. After the deal, the drug’s price increased to $36.

The commission said Ovation knew it faced the threat of imminent entry from a new drug to treat the heart defect. It purchased the U.S. rights to that competitor in January 2006 from Abbot Laboratories Inc. The size of the transaction fell below the threshold for reporting to federal antitrust agencies.

Once Ovation acquired the rights to the competing drug, it promptly raised its price for Indocin from $36 to $500 per vial. When NeoProfen was launched in July 2006, Ovation set a price of about $483 a vial.

“Absent Ovation’s acquisition of NeoProfen, the two products would have competed fiercely against each other,” Leibowitz wrote. “That competition would have lowered prices and benefited consumers, which is precisely what the antitrust laws protect, and why we are bringing this action today.”

The lawsuit was filed in the U.S. District Court in Minnesota.

U.S Sen. Amy Klobuchar, D-Minn., raised concerns with the FTC after a hospital in her state contacted her about the price of medicine for treating the heart defect.

“The rising cost of health care is bad enough without the added problem of price-gouging by a drug company,” Klobuchar said in a written statement issued Tuesday.

Copy the Story Link

Only subscribers are eligible to post comments. Please subscribe or login first for digital access. Here’s why.

Use the form below to reset your password. When you've submitted your account email, we will send an email with a reset code.