Major drug makers have agreed to voluntary guidelines by the U.S. Food and Drug Administration (FDA) that would effectively ban the use of medically important antibiotics to promote faster growth in healthy livestock. Although the program is currently voluntary, the FDA announced last week that 25 out of 26 of the largest drug manufacturers have agreed to follow it.
The new U.S. guidelines target hundreds of drugs that are considered important for human health, with the goal of limiting antibiotic-resistance disease in humans. Repeated exposure to antibiotics can create germs that no longer respond to drugs when treating illness.
Both the meat industry and animal pharmaceutical companies are supporting the program. Supporting companies include the animal health divisions of Bayer Healthcare, Eli Lilly & Co., and Zoetis, Inc. 283 products or applications are affected by the voluntary guidelines.
Livestock production has long been suspected as a key source in the U.S. in the development of antibiotic-resistant superbugs. Governments in other major countries have been more proactive. The European Union has banned antibiotic use for livestock growth since 2006.
Consumers have been clamoring for antibiotic-free meat. McDonald’s and other companies have been attempting to limit drugs in their meat, and are encouraging animal producers to support them.
The Centers for Disease Control and Prevention (CDC) director Dr. Tom Friedman recently told the U.S. House of Representatives that antibiotic resistance is one of the country’s “most serious health threats,” stating that over 23,000 deaths occur annually due to antibiotic-resistant infections, and that over 2 million people become sick.
At this time the voluntary program requirements are simple: the drugmakers agree that labels on antibiotics will no longer include the use of their products for growth-enhancing potential of healthy livestock, which essentially bans farmers from using them for that purpose.
The use of antibiotics for sick animals is still allowed, but the products will only be available by veterinary prescription. Rosa DeLaura, member of U.S. House of Representatives, said that currently 80 percent of antibiotics sold in the U.S. are given to healthy animals, typically in their food or water, and that the antibiotics are frequently used to compensate for unsanitary and crowded conditions.
Critics of the voluntary program have expressed concern that the guidelines are too weak because 63 percent of the drugs affected by them can still be used for disease protection. Although illegal to use the antibiotics to create heavier animals that grow faster, farmers could still give low doses for long periods for routine disease prevention, a practice that could still promote antibiotic resistance.
Skeptics worry about compliance with a voluntary program, and think perhaps the FDA has constructed guidelines based on what the food and pharmaceutical industries would find acceptable. But the FDA said a voluntary program was faster to adopt than going through a long regulatory process.
The guidelines were publicized in December, but it was just announced last week that the 25 drug makers that sell antibiotics used for growth enhancements will follow them. The only company not agreeing is PharmaqAS, a Norwegian manufacturer whose drugs are used on farmed fish and are only used to treat diseased fish, not promote growth. The company thought the new guidelines are not relevant, but are continuing to review them.
It will take three years for the pharmaceutical manufacturers to phase in the new antibiotic labeling that would ban their use on healthy livestock for the purpose of growth enhancement.
By Beth A. Balen