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December 11th, 2013

New Antibiotic Guidelines, but the Devil’s in the Details

By Sarah Borron


Today the FDA released voluntary guidelines for drug companies and livestock producers, in a long overdue update to the policy antibiotic use in livestock. But as always, the devil is in the details.

For background, livestock producers routinely give livestock low doses of antibiotics in feed in order to promote growth and prevent disease, a practice known as subtherapeutic use. Unfortunately, this practice promotes the development of antibiotic-resistant bacteria, a growing public health crisis.

FDA’s new guidance requests that pharmaceutical companies change the labels on medications used in feed. The medication label states how the medicine is legally allowed to be used, and the change FDA is requesting is that antibiotics important in human medicine no longer be labeled for growth promotion purposes. 

FDA assured stakeholders in a call today that two major pharmaceutical companies have already agreed to this label change for the drugs they produce. Once the label has been changed, the drug can only be used in feed to “treat, prevent, or control disease” and requires a veterinary prescription for those uses. Currently, most antibiotics sold in livestock feed are available over the counter without veterinary oversight. 

But FDA’s new strategy still isn’t enough. There are two main problems:

  1. It’s voluntary. FDA officials expressed confidence that pharmaceutical companies will get on board, and companies have a 90-day window to express their intent to FDA. We look forward to FDA’s report of how many drugs will be covered at the end of that 90 days, but no plan was mentioned as to how to deal with stragglers and the agency does not have any mechanism to force companies to make this change in how antibiotics are used.
  2. It doesn’t cover all the ways antibiotics are misused. Antibiotics used in livestock feed for “growth promotion” and “disease prevention” are used very similarly, and, regardless of why drugs are used in low doses in livestock feed, antibiotic-resistant bacteria are still the result. While eliminating growth promotion purposes will be helpful, and increased involvement of veterinarians in disease management is also good, FDA’s action still leaves untouched many practices that need to be banned. FDA currently doesn’t even collect or provide the data that would let us examine this problem more thoroughly. Instead it lumps prevention and treatment uses in one category, despite the significant distinction in what those two choices mean for antibiotic resistance.

We still need a ban on the subtherapeutic use of medically important antibiotics in livestock. 

The Centers for Disease Control and Prevention notes that most uses of antibiotics in agriculture are “injudicious,” and the livestock and animal pharmaceutical industries have a long way to go in ensuring that antibiotics are used responsibly in agriculture. Meanwhile, according to the CDC, two million Americans suffer from antibiotic-resistant bacterial infections a year, and 23,000 people die from those infections. 

If FDA won’t go far enough to get the job done, it’s time for Congress to act. Sign a petition today to ask your Congressperson to sponsor the Preservation of Antibiotics for Medical Treatment Act (PAMTA)/Prevention of Antibiotic Resistance Act (PARA), which would ban subtherapeutic uses of antibiotics in livestock production.

Update: This blog has been updated to reflect the correct numbers of antibiotic-resistant bacterial infections each year. 

One Comment on New Antibiotic Guidelines, but the Devil’s in the Details

  1. Edwin Clendennin says:

    I would like you to sponsor the Preservation of Antibiotics for Medical Treatment Act (PAMTA)/Prevention of Antibiotic Resistance Act (PARA), which would ban subtherapeutic uses of antibiotics in livestock production.

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