FDA dings Hospira for ‘misleading’ ads for blood drug

FDA dings Hospira for ‘misleading’ ads for blood drug

January 26th, 2012 // 2:10 pm @ jmpickett

The U.S. Food and Drug Administration has admonished Hospira Inc. for overstating the capabilities of a product used to offset severe blood loss.

The FDA has asked the Lake Forest-based medical products manufacturer to change its marketing of Voluven, a plasma substitute designed to increase patients’ blood volume after surgery or trauma.

In an apparent bid to boost sales, Hospira has improperly claimed that Voluven also can be used during major abdominal surgery, to prime cardiac pumps and to treat swelling, according to an FDA letter to a Hospira executive.

The company also is making unsubstantiated claims about Voluven’s effectiveness compared to similar products, according to the Dec. 16 letter from an official at the FDA’s Center for Biologics Evaluation and Research.

“If you have data to support such claims, please submit them to the FDA,” the letter said. “Your promotional material is false and misleading because it makes unsubstantiated efficacy and comparative claims and minimizes risk information.”

A Hospira spokeswoman said in an email that the company takes the FDA’s letter seriously. It has contacted the agency about some of the issues raised and has stopped distribution of the sales materials in question.

Hospira is “working diligently to revise pieces that address the agency’s concerns,” she said. “We have also removed nearly all of the impacted pieces from our website and will complete that process shortly.”

Annual sales of Voluven could not be determined, but it’s not big seller for Hospira, the product’s only U.S. distributor. Manufactured in Norway by a subsidiary of Fresenius A.G., the drug gained FDA approval in 2007.

The notice, called an “untitled letter,” is used by the FDA to cite infractions that aren’t significant enough to merit a more serious warning letter. Both types of missives are advisory and don’t necessarily signal regulatory action.

But the letter comes at a critical time in Hospira’s relationship with the FDA, which last year alleged safety violations at the company’s troubled Rocky Mount, N.C., plant.

Related story: Hospira’s stock falls as analysts spar

Hospira has said it is working to correct the safety problems and will report its progress during its earnings conference call in February.

FDA notices are not uncommon as drugmakers push the envelope of acceptable promotion, experts said. Last year, the FDA sent at least 38 letters to pharmaceutical manufacturers identifying “false or misleading” elements of drug promotional materials.

Voluven already has a spotty reputation. Over the past decade, German anesthesiologist and blood researcher Joachim Boldt has published dozens of studies suggesting that hydroxyethyl starches such as Voluven were as effective as alternatives without the negative side effects like profuse bleeding. That research fell into disrepute amid 2010 allegations that Dr. Boldt’s data was fraudulent.

Voluven has “already got a stain on it because you can’t really tell how it works,” said Erin Fox, manager of the Drug Information Service at the University of Utah Hospitals and Clinics.

Though widely used in Europe, the drug has had less success in the United States because of the scandal, Ms. Fox said.