June 22, 2018

Senators Introduce Bill to Strengthen Oversight of Antibiotic Use in Animals

Legislation Would Help Prevent Antibiotic Resistance

Bill Text (PDF) | One-Pager (PDF)

Washington, DC - United States Senators Elizabeth Warren (D-Mass.), Kirsten Gillibrand (D-N.Y.), Dianne Feinstein (D-Calif.), and Richard Blumenthal (D-Conn.) today unveiled the Strengthening Antibiotic Oversight Act.  The legislation would help prevent antibiotic resistance by strengthening the oversight of medically important antibiotics administered to food animals.  According to the Centers for Disease Control and Prevention, approximately two million people in the U.S. develop antibiotic-resistant infections every year, and one in five antibiotic-resistant infections in humans comes from bacteria in animals and food.

"The FDA has taken a number of steps to address the issue of antibiotic resistance, but with two million Americans developing antibiotic-resistant infections every year, it's clear that more work needs to be done," said Senator Warren. "One way to approach this is to reduce the overuse of antibiotics in animals.  I'm glad to partner with my colleagues on a bill to help the FDA collect better data and support more careful use of antibiotics."

"With more and more Americans falling ill because of antibiotic-resistant bacteria in our food, it's clear that Congress must do more to reduce the amount of antibiotics used to produce our food," said Senator Gillibrand, a member of the Senate Agriculture Committee. "I am proud to introduce this legislation to help prevent antibiotic resistance and keep our food supply safe.  This is an urgent public health issue, and I will fight hard in the Senate to get this bill passed."

"The overuse of antibiotics in livestock has resulted in an antibiotics arms race," said Senator Feinstein. "As quickly as we create new antibiotics, new strains of disease emerge that are growing increasingly resistant to those stronger antibiotics. Our bill will give the FDA greater oversight and ensure medically-important antibiotics are used sparingly."

The overuse of medically important antibiotics in food animals can encourage the growth of drug resistant bacteria that can cause hard-to-treat human diseases.  Bacteria can spread from animals to animal products, contaminated water or soil, or the environment.  In order to prevent the development of antibiotic-resistant bacteria, it is important that antibiotics be used judiciously in animals.

The Food and Drug Administration (FDA) approves drugs used in animals and helps oversee veterinary use of animal drugs, including antibiotics used in animals.  While the FDA has long acknowledged that using medically important antibiotics in food animals for long or unlimited durations increases the risk of antibiotic resistance, current FDA rules do not contain duration limits regulating how much of an antibiotic can be used in an animal for a specified amount of time for all medically important antibiotics.  A 2017 report by the Government Accountability Office (GAO) found gaps in oversight and identified several actions needed to prevent the continued use of antibiotics for general prevention of disease.  The GAO's recommendations included that the FDA establish duration limits for all medically important antibiotics used in food animals and that better data on antibiotic use in animals be collected. 

The Strengthening Antibiotic Oversight Act takes several steps to address the issue of antibiotic resistance. The legislation requires the FDA to review the durations of use of approved indications of medically-important antibiotics labeled for use in animals and gives the FDA authority to withdraw approvals for unjustified duration limits.  The bill also directs the FDA to use funds collected through animal drug user fees to collect and report data on antibiotics delivered to farms, through sampling of veterinary feed directives and feed distribution reports.

The legislation is supported by the U.S. Public Interest Research Group (PIRG), Antibiotic Resistance Action Center at GWU, Food Animal Concerns Trust (FACT), Center for Science in the Public Interest (CSPI), Consumer Federation of America (CFA), Health Care Without Harm, Clinician Champions in Comprehensive Antibiotic Stewardship, Johns Hopkins Center for a Livable Future, Humane Society Legislative Fund, Center for Foodborne Illness Research and Prevention (CFI), and the Keep Antibiotics Working Coalition.

Senators Warren, Gillibrand, Feinstein and Blumenthal have been leaders in efforts to call for increased oversight by the FDA of antibiotic use in animals.  Last year, the Senators supported legislation to preserve the effectiveness of medically important antibiotics used to treat human and animal bacterial diseases. Senators Warren, Gillibrand and Feinstein also joined their colleagues in calling on the Departments of Health and Human Services and Agriculture to increase collaboration and oversight to reduce the inappropriate use of medically important antibiotics in food animal production.  In February, Senator Warren raised the issue in a hearing of the Senate Health, Education, Labor, and Pensions (HELP) Committee.