FDA plans curbs on animal antibiotics

WASHINGTON -- The government plans to impose strict new rules on antibiotics given to farm animals to combat concerns that the medicines are creating drug-resistant germs that wind up in the meat people eat.

Antibiotics are fast losing their ability to fight infections, mostly because people misuse the vital drugs: Doctors often overprescribe them and patients often don't take them properly.But scientists say antibiotics used on the farm now are causing foodborne bacteria to mutate into treatment-resistant forms -- so the Food and Drug Administration is preparing rules to try to curb the problem.

"It's an issue that won't go away and can no longer be ignored," said Michigan veterinarian Keith Sterner, who chaired a panel of FDA's advisers that backed most of the agency's plans Tuesday.

The advisory committee said FDA's plan to force antibiotic manufacturers to conduct on-the-farm testing of drug resistance probably would never work. But overall, the FDA has proposed "a sound framework" of more strict animal drug regulation, Sterner said.

A two-day meeting to deliberate the FDA's proposals highlighted how bitter a controversy the issue is. On one side, the animal drug industry denies there is any serious risk to consumers, noting that no one has died from eating meat tainted with untreatable germs. On the other side, public health experts say they must act to protect consumers from that ever happening.

Critics "never stood at the bedside of a critically ill patient ... hoping the antibiotics will work and having to deal with the consequences when they don't," said Dr. David Bell of the Centers for Disease Control and Prevention. He pleaded with the industry to find a compromise that protects consumers while still providing farmers with drugs vital for animal health.

Manufacturers adamantly oppose many of FDA's plans, saying the rules would make it too difficult -- and expensive -- to create new antibiotics for animals. They argued that the government instead should study whether on-the-farm antibiotics really pose an imminent threat, and educate farmers and veterinarians to more prudently use the drugs.

"We believe the agency is overreacting," said Dr. Brendan Fox, president of Elanco Animal Health.

That prompted a fierce reaction from one of FDA's advisors: "If there is no risk, you shouldn't be afraid of" the FDA's rules, said CDC's Dr. Frederick Angulo.

Almost half the 50 million pounds of U.S.-produced antibiotics is used in animals. Eighty percent is used, not to treat sick animals, but to promote animals' growth by adding small doses into their feed.