January 16, 2019

FDA Heralds Drop in Antibiotic Use in Farm Animals: Is It Warranted?

The FDA is heralding a drop in antibiotic use in farm animals from 2016 to 2017. This issue is critical to human health, since antibiotic-resistant bacteria are being identified in more and more human food poisoning outbreaks. The World Health Organization warned the medical community about this problem in 2012. At that time, Dr. Margaret Chan said that “antibiotic resistance could end modern medicine as we know it.”

Antibiotic Resistance

And that body issued its first report on antibiotic resistance earlier this year, which showed that this is a serious situation worldwide. In 2015, the CDC released a report that stated antibiotic resistant bacteria sicken 2,000,000 Americans every year. At least 23,000 of those patients die.

Medically important antibiotics have been used for decades in farm animals that are not ill. These drugs are used to promote weight gain and to reduce the risk of illness when these animals are raised in poor and crowded conditions. When used in animals that are not sick, bacteria can develop resistance to these drugs.

In the new report, officials say that there was a 33% decline in domestic sales and distribution of medical important antimicrobials intended for use in food-producing animals. This is a decline of 41% since 2015, which was the peak year of sales/distribution.

This is an impressive drop, since the government only issued guidance documents about this issue, which do not have the force of law behind them.

Guidance for Industry #213

The FDA published Guidance for Industry #213, New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals, which is marked as “contains nonbonding recommendations.” The document states “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.” In addition, drug sponsors were asked to implement principles described in the document, but were not required to do so.

The notice states that “The successful implementation of changes, such as those outlined in GFI #213, depend heavily on the commitment of our key partners and stakeholders, including animal pharmaceutical and feed industries, the animal agriculture community, the veterinary community, and other federal and state agencies, such as the U.S. Department of Agriculture.”

Food Safety Watchdogs Raise Issues

But food safety watchdogs say that there is need for improvement in methods and timing about this issue. The Center for Science in the Public Interest released a press statement that states sales of injectable, oral, and intramammary antibiotics have increased slightly over the past year. And the FDA has not published antibiotic figures that account for animal weight.

Pew Charitable Trusts reviewed the plan and is “encouraged by the scope and focus.” But they want the FDA to speed up the timelines they have set because this is such an important issue. PEW also adds that some of these antibiotics, which are ideally administered under veterinary oversight, can be purchased over the counter without a prescription. They are also concerned that 1/3 of medically important antibiotics can be given to farm animals for long or undefined durations of use.

The longer an antibiotic is used, the more risk there is for bacteria to evolve and develop resistance against that drug.

And the Pew analysis found that some labels on these antibiotics state that they can be used for “maintaining weight gains during times of stress,” which is problematic. FDA has said they will address these uses, but has not yet done so.

And there’s another issue. Appendix A, which was drafted in 2003 and hasn’t been updated, doesn’t list some antibiotics as medically important. The World Health Organization (WHO) considers some of those drugs, including colistin and bacitracin, to be critically important to human medicine.

The FDA does plan to update Appendix A in the future although a date is not specified. Food safety experts hope that the agency speeds up its guideline development to help safe these medically important antibiotics.

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