Mediators Rule FDA Made Mistake
September 7, 2001WASHINGTON (AP) -- In a big upset for the powerful Food and
Drug Administration, a panel of mediators ruled Thursday that the FDA erred
in not approving a gel that promises to reduce internal scarring from pelvic
surgery. The panel's decision could be precedent-setting - and came about
after companies whose products were rejected complained to Congress that
their only recourse was to go to court, something few tried.
Congress ordered the FDA to come up with other ways to resolve disputes.
Medical device chief Dr. David Feigal tried a novel approach for his arm of
the agency, assembling a panel of independent scientific advisers to vote on
who's right.
Thursday, the panel met for the first time and handed a victory to
Minnesota-based Lifecore Biomedical Inc., saying its Intragel scar-reducing
product does offer a benefit - albeit a small one - and therefore should be
approved. Now FDA's Feigal must decide whether to accept the panel's
recommendation and allow Intragel to be sold. Through a spokeswoman, Feigal
declined comment Thursday.
Intragel is a lubricating gel intended to be put into the pelvic cavity
during certain types of gynecologic surgery to reduce adhesions. Adhesions
are internal scar tissue that can join tissues and organs that normally are
separate, leading to chronic pain or intestinal obstruction. There are
various adhesion-preventing treatments, but experts say better ones are
needed.
Lifecore argued its Intragel offered a good new alternative, and the product
is sold in Europe. But last year, FDA's medical device advisers recommended
rejecting it, saying Lifecore didn't properly prove effectiveness and that
one study found Intragel recipients had twice the risk of infection as other
patients. The FDA agreed and rejected Intragel.
Lifecore appealed, and Thursday the new dispute panel sided with the small
company. ``The evidence was compelling as presented in favor of'' Intragel,
said panel chairman Dr. Scott Ramsey of the Fred Hutchinson Cancer Center in
Seattle.
Studies showed Intragel recipients had slightly fewer severe adhesions, a
small benefit but one that panelists decided would help people, he said.
Also, so few patients suffered infections that there's no way to blame
Intragel, Ramsey said.
The FDA's different opinion seemed to come because they used harsher
statistical interpretations of Lifecore's scientific data, and wouldn't
consider better results from Europe, Ramsey said.
The panelists knew their decision was precedent-setting.
``Whether another dispute is going to have such a compelling set of evidence
is hard to know,'' Ramsey said. ``I hope this still is going to be used as a
means of last resort for disputes.''
