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LifeCore to take surgical gel to FDA dispute panel
By Lisa Richwine
WASHINGTON, Sept 5 (Reuters) - Medical device maker LifeCore Biomedical Inc. <LCBM.O> on Thursday will challenge U.S. regulators' rejection of its surgical gel for women in the first test of a special panel created to review disputes.
The Food and Drug Administration last year turned down LifeCore's application to market the product, called Gynecare Intergel. LifeCore says the FDA misinterpreted study results, and the company is asking the panel to weigh in.
The dispute resolution panel was set up under a 1997 FDA reform law to give companies a way to object to product rejections, but it has never been tested.
LifeCore argues that Gynecare Intergel can safely reduce the rate and severity of post-surgical adhesions that can cause pain and infertility for women after gynecological surgery. Adhesions are fibrous bands of scar tissue that bind together normally separate anatomical areas.
But an FDA advisory panel recommended against approval in January 2000. The FDA, in rejecting the product in November 2000, raised concerns about infection risks and expressed skepticism about the gel's effectiveness.
"We believe they simply didn't understand the data set," LifeCore President and Chief Executive Jim Bracke in an interview. "It's a very complex data set."
Bracke said FDA reviewers unfairly attributed some infections to the surgical solution, including one that was preexisting before surgery. Even assuming Intergel contributed to those problems, both the FDA and the company agreed that infection rates were similar between Intergel patients and a control group, he said.
"However, the reviewer at the FDA said 'I still think it could be a problem with more numbers.' That's scientifically disingenuous. That's why you have statistics," Bracke said.
Bracke said FDA reviewers also unfairly interpreted data on effectiveness by including patients who opted not to have a follow-up surgery as treatment failures. Bracke said those patients were helped by Gynecare Intergel because they felt good enough not to need a second surgery.
He acknowledged that Intergel did not help everyone in the study, which he said bothered the FDA, but said the product did have an effect in the most severe cases. Overall, patients were five times less likely to have severe problems from adhesions after surgery if treated with the gel, Bracke said.
FDA reviewers, in documents posted on the agency's Web site (http://www.fda.gov/) on Wednesday, again expressed doubts about the product.
Statistical reviewer Richard Kotz said one analysis of U.S. patients "shows no difference between Intergel and control" for the extent and severity of adhesions and other measures. Part of LifeCore's studies were done in Europe.
Roxolana Horbowyj, a clinical reviewer, said infection rates for U.S. patients were 4.9 percent with Intergel compared with 2 percent for the control group, "which is clinically notable for young, healthy patients undergoing clean procedures."
Both sides will have time to present their views at the public meeting of the dispute panel. The panel will be asked to vote on whether to recommend approval for the gel and send a report to the head of the FDA center that reviews devices, who will then decide within about six weeks whether to clear the product for marketing, FDA spokeswoman Sharon Snider said.
Gynecare Intergel would be marketed in the United States by Johnson & Johnson <JNJ.N> if approved. Bracke said he thinks the gel could have sales of hundreds of millions of dollars.
The product already is approved in about two dozen countries. Chaska, Minnesota-based LifeCore, which makes various medical devices including dental implants, had annual revenues of about $36 million.
Elizabeth Weatherman, a venture capitalist with Warburg Pincus, said the meeting was important for potential investors to see how companies fare when fighting FDA decisions.
"We're very interested in seeing that the process is fair and that the panel is truly independent of the sponsor and the FDA," said Weatherman, who plans to speak at the meeting on behalf of the National Venture Capital Association's medical industry group.
14:36 09-05-01 |
