New Antibiotics Bill Addresses the Threat of Superbugs

U.S. Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Preventing Antibiotic Resistance Act on March 2, 2015. The bipartisan legislation would help reduce the public health threat of superbugs by compelling drugmakers to demonstrate that human antibiotics approved for use in livestock to prevent or control disease do not unduly contribute to drug resistance.

Read the letter from The Pew Charitable Trusts thanking the senators for their leadership.

The Honorable Dianne Feinstein
U.S. Senate
331 Hart Building
Washington, DC 20510

The Honorable Susan Collins
U.S. Senate
413 Dirksen Building
Washington, DC 20510

Dear Senators Feinstein and Collins:

On behalf of The Pew Charitable Trusts, an independent, nonpartisan research and policy organization, I am writing to thank you for introducing the Preventing Antibiotic Resistance Act of 2015 (PARA). PARA is an important bill that provides a targeted, efficient, and meaningful path forward to reduce the public health threat of antibiotic-resistant bacteria.

The U.S. Centers for Disease Control and Prevention (CDC) conservatively estimates that antibiotic-resistant infections kill at least 23,000 people annually and result in up to $20 billion in excess health care costs. The CDC recognizes that overuse of antibiotics in human medicine and in agriculture contributes to resistant infections in humans. Your bipartisan legislative proposal provides a fresh approach to a rapidly evolving landscape.

As you know, the U.S. Food and Drug Administration (FDA) is currently working with drug makers to implement a voluntary policy to eliminate approved growth-promoting uses in food animals of those antibiotics that are used in human medicine. FDA is also working to improve veterinary oversight of all in-feed and water uses of those drugs. We are encouraged that FDA expects this policy, embodied in Guidance for Industry #213, to be fully implemented by December 2016. This is an important step.

However, even after Guidance #213 is implemented, many of these same drugs will continue to be available for use in food animal production, including administration to healthy animals for purposes of disease prevention – sometimes at the same dose as used for growth promotion and for indefinite durations of treatment. In order to ensure that antibiotics are used appropriately based on the best available evidence and taking into account public health and the need to prevent emergence of resistance, it is essential that these uses be reviewed.

PARA would require drug makers to demonstrate that human antibiotics that are approved for use in animal feed or water to prevent or control disease do not unduly contribute to antibiotic resistance, and would empower FDA to make an evidence-based determination regarding the potential impact of medically important animal antibiotics on human health.

We thank you for your continued leadership in the fight to curb antibiotic resistance. Sincerely,

Laura Rogers
Director, Antibiotic Resistance Project