new rule that aims to safeguard essential antibiotics for humans by limiting their use in food animals is now fully in effect.
Under the Food and Drug Administration policy, antibiotics that have been designated “medically important” — in other words, they’re needed to treat people — cannot legally be given to healthy animals to speed their growth. The policy, three years in the making, required producers of agricultural antibiotics to change labeling on the drugs to make clear they should not be used for so-called growth promotion. All manufacturers agreed to abide by the new rule.
The policy also requires that from now on, food animals can only be given medically important drugs under the supervision of a veterinarian — a move designed to restrict their use to the treatment of animal illnesses.
An FDA report on antibiotic use in food-producing animals released just before Christmas revealed that sales of medically important antibiotics rose by 2 percent in 2015, and that from 2009 to 2015 sales of these drugs to the food animal sector increased by 26 percent. The increased sales in 2015 could be the result of a commensurate rise in food animals produced — but critics of the heavy use of these drugs in agriculture note sales haven’t come down.
Though there are still loopholes that need to be closed, the new policy represents a major step forward, said Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics and Policy, based in Washington, D.C.
“Before this came about, you could go to a veterinary feed supply store and basically buy an 80-pound bag or 100-pound bag of antibiotics without a prescription, whereas to get 200 grams of that would require a prescription for human use. And that did not make any sense at all,” Laxminarayan told STAT.
Putting these particular antibiotics under the control of veterinarians will make it harder for farmers to use them. And it will increase the cost of doing so, something Laxminarayan predicted will discourage nonessential use.
“Anything that increases the cost of using antibiotics essentially will push manufacturers away from using antibiotics,’’ he said.
Scientists and public health professionals have long warned that the increasing use of antibiotics in the rearing of food animals such as chickens, pigs and cattle, and farmed fish and seafood is fueling a rise in so-called superbugs — bacteria capable of evading the drugs.
That puts at risk procedures that have revolutionized modern medicine. Organ transplants, cardiac bypass surgeries, even safe caesarean section births are an accepted part of medical practice but could become much more dangerous to perform if superbugs continue to proliferate.
A major report on the threat, commissioned by the British government and published last May, painted the situation in bleak tones.
Where about 700,000 a year currently die from antibiotic-resistant infections, that toll could rise to 10 million a year in 2050, it warned. Global concern about antibiotic resistance has surged to the point that in September the UN General Assembly held a high-level meeting on the issue — only the fourth time in the UN’s history that the General Assembly has considered a health issue.
More judicious use of the drugs in human medicine is a key part of preserving their utility. But it is estimated that about 70 percent of antibiotics are used in agriculture, often not to treat illnesses but to fend off diseases linked to the crowded, high-stress conditions of factory farming or to promote growth.
The recently released FDA report on antibiotic use in food animal production revealed that 62 percent of antibiotics given to these animals in 2015 were medically important for human health. The FDA policy does not address antibiotics that are not medically important. Food livestock producers will still have open access to them.
Pew Trusts antibiotics expert Karin Hoelzer is hopeful the new FDA policy, known as Guidance for Industry #213, will make a difference.
“The successful implementation of this guidance marks a fundamental shift in how antibiotics can be given to animals in the US and is indicative of the growing consensus that antibiotics should be used only when necessary and appropriate to protect animal health,” Hoelzer wrote in a blog post published on the Pew Trusts’ website.
Hoelzer, a senior officer with Pew’s health programs, called the collaboration between the FDA and manufacturers on this issue “encouraging.” “Their collective action will help advance the global effort to slow the emergence of drug-resistant bacteria and preserve the effectiveness of these lifesaving drugs,” she said.
Still, Hoelzer noted more work needs to be done.
For example, this loophole: Many of the medically important antibiotics used in agriculture don’t have limits on how long they can be used, meaning even therapeutic use could result in animals ingesting the drugs for prolonged periods of time. In fact, an analysis done by the Pew Trusts late last summer found that about one-third of medically important drugs used in food animal agriculture did not include duration of use information in their labeling materials.
In September, the FDA signaled it was exploring how to address this and other loopholes and asked for public comment. The comment period was meant to end in mid-December, but has been extended until March 13. Another problem the FDA hopes to address through that consultation process relates to the blurry line between growth promotion and disease prevention.
As things currently stand, antibiotics can be used to prevent illness, which can also lead to prolonged use. Advocates for more judicious use of antibiotics in agriculture argue that this is growth promotion by another name. They insist disease prevention goals should be achieved through better and more humane production practices that reduce the disease risks associated with factory farming.
This story has been updated to reflect that the policy is now fully in effect.