April 02, 2019

FDA Takes Steps to Increase Oversight of Medically Important Antimicrobial Drugs

FDA Supports Efforts to Limit the Overuse of Medically Important Antimicrobial Drugs in Food Animals; Announcement Comes After Senator Warren Pressed the FDA to Strengthen Oversight to Combat Antibiotic Resistance

Washington, DC – United States Senator Elizabeth Warren (D-Mass.) applauded an announcement from the U.S. Food and Drug Administration (FDA) that they will fund research on durations of use for medically important antimicrobial drugs in food animals. The announcement comes after Senator Warren sent a letter to the FDA in July, calling on the agency to improve oversight of medically important antibiotics in food animals and highlighting gaps in FDA animal drug policy that contribute to human disease, including the lack of duration limits for a third of products containing medically important antibiotics. Duration limits spell out how long an antibiotic should be used to treat a specific animal illness and are an important component of efforts to reduce overuse of antibiotics in animals, which is a key contributor to the rise of antibiotic-resistant bacteria. As part of the FDA’s announcement, the agency posted online a list of medically important antimicrobials that currently lack duration limits, which Senator Warren had requested. She further requested the agency increase its efforts to strengthen oversight of the use of medically important antibiotics and limit antibiotic resistance.
One in five antibiotic-resistant infections in humans come from bacteria in animals and food. Using medically important antimicrobials in food animals for long or unlimited durations increases the risk of antibiotic resistance. Explicitly defined duration limits allow for more judicious use of antibiotics, and will help combat antibiotic resistance.
“I’m pleased that the FDA is continuing in the right direction by making a further commitment to study the use of medically important antimicrobial drugs,” Senator Warren said. “I look forward to their findings and ongoing work to reduce the overuse and misuse of antimicrobial drugs in food animals and limit antibiotic resistance in humans.”
Senator Warren has continuously worked to strengthen the oversight of antibiotic use in animals:

  • In June 2018, 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 2017, 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; and

  • 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.