Regulatory Focus™ > News Articles > Legislation Would Limit Prescribing of Antibiotics to Unhealthy Animals

Legislation Would Limit Prescribing of Antibiotics to Unhealthy Animals

Posted 28 June 2013 | By Alexander Gaffney, RAC

Influential Democratic Senator Diane Feinstein (D-CA) has introduced a new piece of legislation that would restrict the use of antibiotics in agricultural settings, requiring the US Food and Drug Administration (FDA) to prevent the use of human antibiotics in the feed or water of healthy farm animals if their use would "jeopardize human health."


In recent decades, regulators and public health officials have become increasingly concerned about the resistance of bacteria to antibiotic regimens, particularly as some strains began to develop resistance to multiple drug regimens.

However, FDA has done relatively little to combat antibiotic resistance since it first started developing regulations on the use of antibiotics in animal feed in 1977. At present, the overwhelming majority of antibiotics in the US are used in animals, and especially those raised for consumption. The fear of many public health officials is that dosing animals with antibiotics over a long period of time vastly increases the potential development of antibiotic-resistant strains of bacteria, which can then affect people outside of agricultural settings.

In 2012, FDA proposed changes to the way in which antibiotics are prescribed in the US, requiring farmers and ranchers to obtain prescriptions to use antibiotics in animals. And under considerable pressure from judicial authorities, FDA also released a guidance document - Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (GFI #209) - that called for companies to cut down on the injudicious use of antibiotics.

"It is critical that we take action to protect public health," said FDA Commissioner Margaret Hamburg in a statement at the time. "The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available."

Considerable Criticism

However, FDA's actions since then have frequently angered various groups, including members of Congress. In June 2013, for example, FDA appealed a ruling that would have required it to withdraw approval for most antibiotics used in animal feed or withdraw approval for their non-therapeutic applications. That decision won a sharp rebuke from Rep. Louise Slaughter (D-NY), who said the agency had "buried their heads in the sand and ignored the threat of antibiotic resistance."

"As far as I'm concerned, FDA's decision to appeal [...] is nothing short of a dereliction of duty," added Slaughter. 

And in March 2013, former FDA Commissioner David Kessler said the agency's actions with respect to antibiotic resistance were "aiding and abetting" the pharmaceutical industry while leaving treatment-resistant bacteria to proliferate.

"We cannot avoid tough questions because we're afraid of the answers," Kessler wrote. "Lawmakers must let the public know how the drugs they need to stay well are being used to produce cheaper meat."

Feinstein's Bill

Feinstein's comments - and bill - mirror those made by Kessler and Slaughter, though she avoids criticizing FDA.

"The irresponsible use of antibiotics is dangerous, and tens of thousands of people in the U.S. die each year from antibiotic-resistant infections," Feinstein said in a statement. "We must preserve the efficacy of these life-saving drugs by carefully restricting their overuse in our agriculture products."

Feinstein's bill, the Preventing Antibiotic Resistance Act of 2013, would mandate that pharmaceutical companies demonstrate that products are used to treat "clinically diagnosable diseases - not just to fatten livestock," Feinstein's office explained.

As such, the bill also calls for the phased elimination of nontherapeutic uses of antibiotics in animals within two years of the bill's passage. Two-year exemptions to the requirement may be permitted if a drug is a "medically important antimicrobial."

Applicants will also be required to show with "reasonable certainty" that the drug will not harm human health by promoting the development of antimicrobial resistance if it is used non-therapeutically.

However, the bill's restrictions apply only to "the limited number of antibiotics that are critical to human health," Feinstein explained. "Any drug not used in human medicine is left untouched by this legislation."

The bill would apply to all applications pending at FDA at the time of the bill's passage, as well as all submissions made to the agency thereafter.

Preventing Antibiotic Resistance Act of 2013

Feinstein Statement

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