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[]] First-Ever FDA Dispute Panel Sides With Company
WASHINGTON (Reuters Health) Sept 07, 2001 - A federal dispute panel voted unanimously on Thursday to reverse the US Food and Drug Administration's decision not to approve an adhesion prevention gel manufactured by Lifecore Biomedical. The session was the first time the panel of outside experts had convened to review an FDA decision.
At the heart of the dispute between Lifecore and the FDA was whether the company had submitted sufficient data to demonstrate the clinical benefit of Intergel, a product designed to reduce the risk of adhesions forming in the ovaries or bowel as a result of gynecological surgery.
At present, there is no product in the US specifically approved for the indication. But in November, the FDA said that Intergel could not be approved because the US data submitted did not demonstrate that the product was safe or effective.
Appearing before the panel, Lifecore argued that the agency had failed to consider more robust European data and a modified analysis of the US data that showed that the gel reduced the incidence of adhesions by about 45%.
But the FDA told the panel that it had questions about how to interpret the company's modified analysis and was concerned about combining the US and European data due to differences in surgical practices. The European data were based for the most part on a method of surgery that resulted in a greater number of adhesions than the method used in the US, FDA statistician Richard Kotz said.
The agency also said it was worried by data suggesting the product may increase infection rates.
Chaska, Minnesota-based Lifecore argued that the studies' placebo controls should eliminate concern about differences in the types of surgery performed in the US and Europe. The firm argued that what is relevant is the comparison of placebo and treatment groups.
As for the infection rates, the company maintained that they were not statistically significant when looked at across all the pooled patients. The panel members concurred. Although the absolute numbers in the US were not entirely compelling, the pooling of data from the US and Europe appeared justified, they concluded. "I think what we have here is a really powerful study that really did have consistency," said Dr. Mark D. Carlson, a voting member of the dispute panel and vice chair of clinical programs at the University Hospitals Health System in Cleveland, Ohio.
Under federal regulations, the FDA has 6 weeks to determine whether it will follow the dispute panel's recommendation. Although the agency is not bound by the panel's vote, it will now be difficult to justify refusing approval, said Washington analyst Ira Loss in an interview with Reuters Health.
The dispute panel was created in 1997 by Congress as a means of giving companies access to an independent, public forum if they believed the cards at the agency were stacked against them.
This first decision from the panel could affect the tone of the relationship between the agency and product sponsors, Loss suggested. Had the dispute panel voted against the approval, sponsors might have concluded that they should follow the FDA's advice to a tee, at least when seeking approval of a medical device, he said.
Lifecore CEO Dr. Jim Bracke told Reuters Health that Intergel could be rolled out as early as March if the FDA does decide to change its decision. Lifecore already manufactures the gel for sale in 25 markets, he said, but the actual US launch date will depend on Johnson & Johnson, with whom Lifecore has signed a co-marketing agreement.
Bluefire Research securities analyst Lee A. Schafer told Reuters Health that the panel's decision has larger significance: It shows that the dispute resolution system works and that companies do have a way to challenge the FDA, he said.