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Congresswoman Louise Slaughter

Representing the 25th District of New York

Slaughter Urges FDA to Take Stronger Action to Combat the Growing Threat of Antibiotic Resistance

November 28, 2017
Press Release
Outlines concrete data collection steps to protect public health and preserve the effectiveness of antibiotics

WASHINGTON, DC — Congresswoman Louise M. Slaughter (NY-25) today urged the Food and Drug Administration (FDA) to take stronger action to preserve the effectiveness of antibiotics and protect public health. This effort comes as the FDA continues developing a draft rule (FDA-2017-N-1197) that would impact how antibiotics sold for use in livestock raised for human consumption are measured. Slaughter is the author of the Preservation of Antibiotics for Medical Treatment Act (PAMTA), which would preserve the effectiveness of medically important antibiotics by ending the use of these drugs in healthy food-producing animals, while allowing their use for treatment of sick animals. This bill includes a mandatory restriction on unnecessary non-therapeutic uses of medically important antibiotics in healthy animals, which the World Health Organization recently recommended. Slaughter has also authored the Delivering Antimicrobial Transparency in Animals (DATA) Act to require the FDA to collect and report real-world, on-the-farm usage data including the indication, dose, duration of use, and number of animals treated from large livestock producers.

“Eighty percent of all antibiotics used in the United States are used not on humans but on food-animals, most of which are perfectly healthy. This is dangerous and unsustainable. As I have been saying for years, publically available data on how antimicrobials are being used on farms is critical to preventing resistance and preserving the effectiveness of these live-saving drugs. I urge you to move forward with meaningful and transparent measures that uphold the FDA’s mandate to protect public health and hold the agricultural and pharmaceutical industries profiting from these irresponsible practices accountable,” Slaughter wrote in a letter to Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine at the FDA. “The effectiveness of antibiotics depends on it.”

Slaughter outlined concrete steps the FDA should take as this process continues, including disclosing as much antibiotic sales data as possible, using a methodology that allows comparisons with countries like the E.U. and Canada that are ahead of the US in transparent reporting of how antibiotics are used in livestock, and overcoming the currently insufficient data on antibiotic use practices by moving forward with an on-farm data collection program.

In his 1945 Nobel acceptance speech, Alexander Fleming, who discovered penicillin, warned that overusing antibiotics would cause bacteria to mutate and become resistant to treatment, creating superbugs that were difficult or impossible to cure. That warning has become reality.

More than two million Americans acquire an antibiotic-resistant infection every year, and at least 23,000 die from those infections – more than HIV/AIDS. The average hospitalization period is four days, creating $20-35 billion in excess direct health care costs each year in the U.S.  Globally, 700,000 die each year and the annual cost is estimated to be as high as $1.2 trillion.

Currently, 80 percent of all antibiotics sold in the United States are sold for agricultural use. Most often, these antibiotics are distributed at sub-therapeutic levels to healthy animals as a way to compensate for crowded and unsanitary living conditions or to promote growth. Any effort to stop the growth of antibiotic-resistant bacteria must address the overuse of antibiotics in food-animals.

Slaughter has sponsored PAMTA for the past four terms in office, and was an original cosponsor when the bill was first introduced in 1999. This legislation is supported by 450 organizations, including public health organizations, scientists, the World Health Organization, American Medical Association, National Academy of Sciences and small farmers across the United States.   

The DATA Act would require drug manufacturers to obtain and provide better information to FDA on how their antimicrobial drugs are used in the food-producing animals for which they are approved. It would improve the timing and quality of the data that FDA publicly releases and require large-scale producers of poultry, swine, and livestock to submit data to FDA detailing the type and amount of antibiotics contained in the feed given to their animals. The DATA Act would also require the FDA to coordinate with the USDA to improve the collection of data on the use of antimicrobial drugs in or on food producing animals.

A copy of the letter is available online here and included below:

 

 

November 28, 2017

 

 

Stephen Ostroff, M.D.

Deputy Commissioner for Foods and Veterinary Medicine

U.S. Food and Drug Administration (FDA)

10903 New Hampshire Ave.

Silver Spring, MD 20993

 

Dear Deputy Commissioner Ostroff;

Perhaps you know, I am deeply concerned about the overuse and misuse of antibiotics in animal agriculture which is a significant contributor to the rise of antibiotic resistance.  A strong, mandatory restriction on unnecessary non-therapeutic uses of medically important antibiotics in healthy animals, which the World Health Organization (WHO) recently recommended and I’ve been calling for over many years, is the best and only approach that would ensure the judicious use of antibiotics.

Absent a mandatory approach, as would be established by my bill H.R.1587, the Preservation of Antibiotics for Medical Treatment Act of 2017, the transparent reporting of meaningful and robust antibiotic usage data is necessary.  This will allow the public to determine if the FDA’s current voluntary approach to reducing the overuse of antibiotics in animals via Guidance for Industry (GFI) #209, #213, and the Veterinary Feed Directive is resulting in any improved stewardship within the animal agriculture industry. 

I have repeatedly called on the FDA to enact a framework to collect detailed real-world on-the-farm usage data including the indication, dose, duration of use, and number of animals treated which my bill the Delivering Antimicrobial Transparency in Animals Act would do. Similar recommendations have been made by the FDA’s own Science Advisory Board and the United States Government Accountability Office (GAO), among others. In fact, the FDA’s biomass correction technical paper notes that “reliable data on use practices for the major food-producing species is not available.”

An on-farm data collection program is desperately needed in order to fully understand the drivers of antibiotic use and help researchers develop alternative livestock management practices and disease interventions that would benefit both farmers and public health. Such a program could be accomplished through FDA’s authority to review veterinary feed directives or by working in coordination with the Centers for Disease Control and Prevention (CDC) and U.S. Department of Agriculture (USDA) to expand and improve existing monitoring programs.

Although still falling short of providing real-world on-the-farm usage data, the use of a biomass denominator for adjusting antibiotic sales data, along with the separation of sales data by major food-producing species, would be a welcome improvement over the current situation. In addition to my general concerns, I would like to provide the following comments and recommendations.

1) I am concerned that the use of a biomass denominator based primarily on slaughter weights will result in under-estimation of how livestock are dosed with antimicrobials. The FDA is well aware, as is noted in the technical paper, that antimicrobials are often given to young animals well below slaughter weight. Although any consistently applied method would allow observation of trends, by purposely choosing the largest possible denominator, the FDA is ensuring that the reported mg/TAB value would be as small a number as possible. This could mislead observers to believe that stewardship efforts are being more successful than they actually are.

2) The FDA should enable comparisons to reports currently published by the E.U. and Canada. As the agencies’ own technical paper notes, the U.S. is well behind these countries’ reporting efforts. Comparisons are necessary to allow the public to examine the stewardship efforts of the U.S. livestock industry, along with FDA’s voluntary approach, in a global context. Ideally, a consistent world-wide methodology could be agreed on to better enable future comparisons.

3) This could be accomplished by either deriving a U.S. specific population correction unit (PCU) using the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) methodology and reporting antimicrobial sales data in mg/PCU, in addition to the FDA’s preferred mg/TAB method, or reporting antibiotic sales and animal production data in such a way to enable these calculations by external observers.

4) The FDA should disclose as much antibiotic sales data as possible in the most transparent way possible. All estimations and calculation methodology should be fully disclosed, including those used by industry to provide species level sales estimates, and any year-to-year changes should be fully documented to enable meaningful comparisons to be drawn between reports.

5) The FDA should provide additional details on how it will monitor antimicrobial sales reported in the “other species/unknown” category. This inherently non-transparent categorization could mask potentially problematic uses of antimicrobials in animals and prevent appropriate oversight.

Eighty percent of all antibiotics used in the United States are used not on humans but on food-animals, most of which are perfectly healthy. This is dangerous and unsustainable. As I have been saying for years, publically available data on how antimicrobials are being used on farms is critical to preventing resistance and preserving the effectiveness of these live-saving drugs. I urge you to move forward with meaningful and transparent measures that uphold the FDA’s mandate to protect public health and hold the agricultural and pharmaceutical industries profiting from these irresponsible practices accountable. The effectiveness of antibiotics depends on it.           

Sincerely,

 

 

Louise M. Slaughter

Member of Congress

 

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