July 27, 2018

Warren Presses FDA to Address Gaps in Animal Antibiotic Policy

Senator Stresses Importance of Increased Oversight to Curb Growth of Antibiotic Resistance

Text of letter (PDF)

Washington, D.C. – Today, United States Senator Elizabeth Warren (D-Mass.) called on the U.S. Food and Drug Administration (FDA) to improve oversight of medically-important antibiotics in food animals. In a letter to FDA Commissioner Scott Gottlieb, Warren highlighted gaps in FDA animal drug policy that contribute to human disease and requested increased efforts to limit antibiotic resistance.

While antibiotic drugs are important tools for treating bacterial infections, overuse of these drugs contributes to the growth of antibiotic-resistant bacteria that can cause hard-to-treat infections in humans. Today, resistance has been seen in almost all antibiotics ever developed. The Centers for Disease Control and Prevention (CDC) estimates that more than 2 million people in the U.S. develop antibiotic-resistant infections each year, resulting in over 23,000 deaths and adding as much as $20 billion in health care costs to an already-overburdened system. The CDC also estimates that one in five human infections comes from bacteria in animals and food. 

Though the FDA has acknowledged the risks of using medically-important antimicrobials in food animals over long periods of time, current regulations on duration limits and permitted types of antibiotics fail to adequately restrict the overuse of these drugs.

“Despite the clear need for the judicious use of antibiotics in animals in order to curb the growth of antibiotic resistance, serious gaps remain in the FDA’s oversight of these drugs,” wrote Senator Warren. “I appreciate your public commitments to improving oversight of medically-important antibiotics in food animals, but I am concerned that animal drug user fee legislation currently pending in Congress does not contain requirements that would guarantee the FDA must take these steps.”

Senator Warren’s letter asks for a series of questions about the FDA’s commitment to reviewing approved duration limits, publicly posting a list identifying drugs for which durations of use have not yet been set, and issuing new guidance on all medically-important antibiotics, including those not currently administered under veterinary oversight.

The letter is the latest in a series of efforts by Senator Warren and her colleagues to strengthen oversight of antibiotic use in animals. In June, Senators Warren, Kirsten Gillibrand (D-N.Y.), Dianne Feinstein (D-Calif.), and Richard Blumenthal (D-Conn.) introduced the Strengthening Antibiotic Oversight Act, which requires the FDA to review the durations of use of approved antibiotics and to collect and report data on their use.  In March of last year, Senator Warren joined her 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 April 2016, Senator Warren led a group of Senators in urging then-FDA Commissioner Robert Califf to address clear gaps in the agency's policies on antibiotic use in food animal production.