FDA Proposes Sweeping Limits
On Antibiotics For Livestock

WASHINGTON —(AP)— The government plans to impose strict new rules on antibiotics given to livestock 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 some scientists claim 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 last week.

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.

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.

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.

Already, Europe has drawn the ire of the animal health industry by banning six antibiotics used as animal growth promoters, including one closely related to the vital human antibiotic vancomycin.

Among the FDA's proposals to tackle the issue:

— Companies seeking to sell a new animal antibiotic would have to prove it is not expected to cause significant resistance. (That would mean no new drugs — ever — because it is impossible to prove a negative. Every schoolkid learns that, or at least they did 30 some-odd years ago. Of course, we weren't intellectuals; they live in a different reality. — Ed.)

— The government would test today's level of foodborne drug resistance, and then set limits on how much resistance could increase before an implicated animal antibiotic would be restricted, even banned.

— FDA would rank animal drugs, giving those most closely related to vital human antibiotics extra scrutiny. Some companies might be ordered to conduct on-the-farm animal tests.

FDA advisers said Tuesday that on-the-farm testing may be too complicated to ever work, but agreed with most of FDA's approach. Sterner stressed that animal antibiotics closely related to vital human drugs would have ``a zero threshold'' for increasing resistance.

The FDA will decide which rules to adopt after a public comment period ends in April.