[Mb-civic] Ending Battle With FDA, Bayer Withdraws Poultry Antibiotic - Washington Post

[William Swiggard]

Ending Battle With FDA, Bayer Withdraws Poultry Antibiotic

By Marc Kaufman
Washington Post Staff Writer
Friday, September 9, 2005; Page A03

For the first time, the Food and Drug Administration has succeeded in 
forcing off the market an antibiotic used to treat animals because of 
concerns that it will make similar antibiotics less effective in 
treating people. After a five-year battle, Bayer Corp. said yesterday 
that it would immediately stop selling its poultry antibiotic, Baytril, 
a close relative to its widely used human antibiotic, Cipro. The company 
could have appealed the FDA ban on the drug to a federal court but 
instead decided to comply.

"We disagree with the FDA's conclusion about our drug," said Bayer 
spokesman Robert Walker. "But we understand they made a scientific 
decision, and courts tend to defer back to the agency. . . . It seemed 
like the chances that we would be successful in court were small."

The resolution of the Baytril case opens the door to FDA action against 
other animal antibiotics. The agency has already told the makers of at 
least three types of penicillin used on farm animals that their products 
might raise similar concerns, and regulatory action might be needed.

Yesterday, public health advocates hailed Bayer's decision and the FDA 
actions that precipitated it.

"We applaud Commissioner [Lester M.] Crawford for defending the public's 
health and Bayer for finally recognizing the need to comply with the 
FDA's ruling," said Karen Florini, senior lawyer at Environmental 
Defense and chairwoman of the Keep Antibiotics Working coalition. "Cipro 
is a critical antibiotic for treating human illness. It simply makes no 
sense to allow its effectiveness to be squandered by continued use of 
near-identical drugs in poultry flocks."

All antibiotics grow less effective over time as bacteria evolve to 
become resistant to the drugs' effects. Experts say wider use of an 
antibiotic -- by either animals or people -- leads to a speedier 
development of resistance.

In its battle to continue marketing Baytril for use in poultry flocks, 
Bayer was joined by the Animal Health Institute, which represents drug 
makers, and four poultry trade associations. The company and the groups 
argued that no proof existed that Baytril was making drugs such as Cipro 
less effective, and that the drug's benefits were not properly considered.


http://www.washingtonpost.com/wp-dyn/content/article/2005/09/08/AR2005090801918.html
-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://www.islandlists.com/pipermail/mb-civic/attachments/20050909/b266828d/attachment.htm