WASHINGTON, DC, May 11, 2004 (ENS):
More than 140 health and public interest groups are
urging Bayer Corporation not to appeal a ruling that
upholds the U.S. Food and Drug Administration's (FDA)
ban on the company's Cipro-like antibiotics for use
Bayer has until May 17 to appeal a March ruling by
a federal administrative law judge that upheld the ban.
Federal officials, public health advocates and environmentalists
want the ban to stay in place because the FDA has shown
the use of these drugs to treat chickens reduces the
effectiveness of similar antibiotics in humans.
"The Judge's opinion makes clear that the decision
to ban Baytril is not even remotely a close call,"
the groups said in a letter sent to Bayer Chief Executive
Office and President Dr. Attila Molnar. "The Judge's
68-page decision is based on a formal evidentiary record
that included 388 bound volumes containing more than
1,100 documents, and on cross-examination of experts
lasting for more than a week. Enough is enough."
The FDA first proposed banning the drugs in October
Chicago based Abbott Laboratories, one of two U.S.
producers of Cipro-like drugs for poultry, complied
with the ban, but the other producer, Bayer, appealed
Bayer makes a Cipro-like antibiotic for use in poultry
known as "Baytril."
Both Cipro and Baytril are members of the fluoroquinolone
class of antibiotics and are very similar.
The FDA showed that use of Baytril in poultry reduces
the effectiveness of Cipro in treating campylobacter,
the most common cause of severe bacterial food poisoning.
The six major poultry producers have announced that
they no longer use these drugs in chickens produced
for human consumption.
Many leading food service companies - including McDonald's,
Dairy Queen, Burger King, Domino's, Hardee's, Wendy's,
Popeye's, Subway, and Bon Appetit - also have stated
that they do not purchase chicken raised with fluoroquinolones.
Although no formal appeal has been launched of the
March ruling, ban advocates worry that Bayer plans to
appeal the decision to the FDA Commissioner, who will
then have to review it before affirming or reversing
the administrative law judge's decision.
That process could take months or years, during which
time Baytril would remain on the market.
"In light of Bayer's motto, 'Expertise with Responsibility,'
the responsible action now is to discontinue the manufacture
of Cipro-like drugs for poultry without further procedural
delays," said the letter, which was signed by 143
groups including the American College of Preventative
Medicine, Physicians for Social Responsibility and the
Union of Concerned Scientists.
Copyright Environment News Service (ENS) 2004. All Rights