FDA To Hold Public Meeting, Seek Comments On Antibiotic Overuse In Farm Animals

For decades, livestock farmers inadvertently encouraged the development of drug-resistant bacteria by providing a continuous stream of medically unnecessary antibiotics to their cows, pigs, and chickens — primarily to end up with bigger animals — while the Food and Drug Administration kept the issue on the back-burner. Meanwhile, antibiotic-resistant pathogens sicken more than two million people in the U.S. each year, resulting in at least 23,000 deaths. Now that everyone from consumers to lawmakers to public health advocates to McDonald’s and even Walmart are starting to care about the topic, the FDA is starting to listen.

Earlier today, the FDA announced that it will hold a public hearing in D.C. on Sept. 30, where the agency, along with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention will seek feedback on the best practices for collecting more data about the use of antibiotics in farm animals.

People who can’t attend but want to provide comment on the matter can go to Regulations.gov

Until very recently, not much was known about the sale of antibiotics for use in livestock, other than the fact that more than 80% of all antibiotics sold in the U.S. were being given to farm animals and that the primary purpose of adding the drugs to animal feed was because of their growth-promoting effects.

In late 2013, the FDA asked drug makers to stop selling antibiotics that were only approved for growth-promotion, but since most of the drugs sold for use in animal feed are also approved for medical purposes, not many antibiotics were affected.

Additionally, the FDA said that these drugs should only be provided for medical purposes, but it left open the loophole of prophylactic, low-dose administration of these drugs under the umbrella of “disease prevention.” However, as doctors and scientists have pointed out, it’s exactly that sort of constant, sub-therapeutic use of antibiotics that tends to encourage the development of drug-resistant pathogens.

Critics of the FDA’s soft-touch antibiotics approach have called for more transparency with regard to drug sales data. In order to determine if — and in which ways — antibiotics are being overused, more information is needed than just gross sales volumes. Researchers say they would need to know how much is sold, how it’s used, and on which sorts of animals.

In May 2015, the FDA proposed a new rule would require drug companies to provide sales data in terms of the major food-producing animals that the drugs are being used on.

While this change should offer more granular information for researchers, public health advocates said it didn’t go far enough. They called for more detailed data about on-farm use practices, which would help to find any links between usage patterns and trends in resistance.

“Right now we don’t even know which antibiotics are being fed to which species of animals, and how they are being used,” explains David Wallinga, MD, Senior Health Officer with the Natural Resources Defense Council. “To address the antibiotic resistance crisis, such information is indispensable.”

Rep. Louise Slaughter (NY), a trained microbiologist and and outspoken critic of the FDA’s antibiotics policy, has continued to push the FDA for more data, to close the disease-prevention loophole, and to seek public feedback on the issue.

“After years of fighting the FDA to take meaningful action on antibiotic resistance, I hope that today’s announcement is a turning point in what has become a worldwide crisis,” said Rep. Slaughter in a statement. “For too long, the lack of detailed knowledge of on-farm antibiotic usage has been used by industry to downplay the scope of the problem and avoid responsibility for being part of the solution.”

Slaughter says she’s “cautiously optimistic” that the September meeting will ultimately result in the collection of meaningful on-farm usage data.

Her sentiments were echoed by Wallinga of the NRDC, who called the meeting a “common-sense first step because we want FDA to stop simply relying on rough sale estimates and collect data about how antibiotics are actually being used and distributed to farms.”

Steven Roach, Senior Analyst for Keep Antibiotics Working notes the importance of getting a solid understanding on exactly how antibiotics are being used on farms.

“In order for us to have any hope of saving the antibiotics we have left, we must know, first and foremost, how exactly they are being used, and in what quantities,” said Steven Roach, Senior Analyst for Keep Antibiotics Working. “Despite the widespread recognition that better data on antibiotic use is needed to control the spread of antibiotic resistance, federal agencies have failed to create a system to collect these data in an adequate, consistent, and comprehensive manner.”

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