Invacare, FDA in negotiations

Thursday, December 8, 2011

ELYRIA, Ohio - The U.S. Food and Drug Administration (FDA) has turned up the heat on Invacare.

The FDA has proposed Invacare suspend certain operations at its corporate and wheelchair manufacturing facilities in Elyria until the manufacturer makes changes to its operations. Invacare announced Dec. 8 that it will work with the FDA to negotiate an agreement, called a consent decree, to address its concerns.

"We're going to get this fixed," said Gerald Blouch, Invacare's president and CEO. "We're not victims here. We're taking this on and, at the end of the day, it will be a good thing."

Earlier this year, the FDA sent a warning letter to Invacare detailing concerns that the manufacturer failed to, among other things, correctly document allegations that some of the hospital beds made at its facility in Sanford, Fla., malfunctioned.

Since it received that letter, Invacare has worked to improve its compliance with FDA policies by, for example, working with four outside consultants with experience in medical device regulations, Blouch said.

"We have, for all issues, submitted work plans to the FDA and are giving monthly updates on our progress against those work plans, and we're hitting all of our commitment dates," he said. "We're aggressively working at becoming fully compliant."

Still, for the FDA to propose that Invacare suspend certain operations at two facilities in Elyria, the agency's probably not satisfied with the manufacturer's progress, say sources who have experience working with the FDA and consent decrees. Either Invacare's not making enough improvements or it's not making them fast enough, they say.

Blouch acknowledges that the FDA's proposal "escalates" the situation.

"We're disappointed," he said.

Blouch would say only that the FDA's issues with Invacare involve "various aspects of quality system processes." Issues the FDA cited based on inspections at the Sanford facility included "failure to establish and maintain adequate procedures to identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems," according to documents posted on the agency's website.

Invacare wouldn't be required to suspend certain operations at the Elyria facilities until there is a consent decree, Blouch said. Even then, "the nature of the shutdown is part of the negotiations," he said.

While not good news for Invacare, which saw its stock price drop 28.6% on Dec. 8, consent decrees are fairly routine for manufacturers, say sources. The agreements, they say, are often a way for the government and manufacturers to avoid lawsuits.

The FDA did not get back to HME News by press time with further details on its inspections of the Elyria facilities.