By Thomas Lee
If the Food & Drug Administration has been too cozy with medical device companies in recent years, as some critics charge, Uromedica Inc. must have been missed the memo.
Since 2000, the Plymouth, Minn.-based company has been haggling with the FDA over its balloon device to treat urinary incontinence. Ten years and several clinical studies later, Uromedica is still waiting for FDA approval, although the company is already selling the device in Europe. In November, the agency said it could not yet okay the pre-market approval application Uromedica filed in August 2008.
Last week, Uromedica formally appealed the FDA’s decision to Dr. Jeffrey Shuren, the new director of the agency’s Center for Devices and Radiological Health. It’ll be the first appeal heard by Shuren, who assumed the job in January.
But Uromedica isn’t holding its breath. The man Shuren replaced, Dr. Daniel Schultz, resigned last summer amid criticism that the FDA approved medical devices over the objections of its staff scientists. Schultz has long been a lightening rod for consumer advocacy groups like Public Citizen and the National Research Center for Women and Families.
For example, he supported Acorn Cardiovascular Inc. of New Brighton, Minn., even though two advisory panels and a dispute resolution panel ruled against clearing the company’s cardiac support device. The FDA had already rejected Acorn’s PMA application three times, but with Schultz’s help, the company eventually won approval for another clinical study.
In early 2009, nine staff whistleblowers wrote to the Obama Administration and Congress, accusing the FDA of improperly approving devices despite serious safety concerns. The letter prompted Congressional investigations and calls to toughen the FDA’s PMA and 510(k) approval programs.
So it’s probably safe to say Uromedica still has a tough road to climb. Already, a former FDA scientist is accusing Shuren and the agency of retaliating against him after he raised concerns about how a CT scanner might expose patients to harmful radiation.
“Given this whistleblower environment, I doubt Dr. Shuren will overrule his staff,” said Mark DuVal, a Minneapolis-based lawyer representing Uromedica.
Still, DuVal hopes Shuren will refer the case to an advisory panel, a decision that might come over the next three to four weeks. If not, Uromedica and the FDA will resume their dance.
