Dear Members of the Energy and Commerce Committee, 

We write you as physicians, infectious disease experts, and health professionals working to address the misuse of antibiotics in food animal production. We’re writing to express our concern with expanding conditional approvals in the Animal Drug User Fee Act reauthorization.

Antibiotic-resistant bacteria already claim at least 23,000 American lives a year and sicken millions more.  Without swift action to reduce antibiotic use, experts estimate that drug-resistant infections could kill 10 million people each year worldwide by 2050. 

When meat producers misuse antibiotics, it spurs the growth of antibiotic-resistant bacteria that can spread from farms to communities.  The Centers for Disease Control and Prevention estimate 1 in 5 resistant infections in humans are caused by germs from food and animals.  

Under current law, animal drugs that are likely to be used in only low numbers of animals can be sold for five years without having been shown to be effective as a conditional approval. Similar to orphan drugs in humans, conditional approvals in animals were created to support approval of drugs with small markets. Drug makers are now pushing to expand conditional approvals to basically every animal drug.

Expanding conditional approvals would mean that an animal drug company can market a product containing medically important antibiotics for use in food animals without knowing that it will be effective for the marketed purpose. That would encourage more antibiotic use, which carries the risk of breeding more resistant bacteria, with no guarantee that the drug will be effective for the intended purpose. 

At a time when a “One Health” approach demands that both healthcare professionals and veterinarians work together to tackle antibiotic resistance, conditional approvals for using animal drugs is a serious step in the wrong direction. To reduce antibiotic use and preserve the efficacy of these medicines for the future, we urge you not to expand conditional approvals in the upcoming ADUFA reauthorization.

Additionally, 32% of the products containing medically important drugs for use in food animals have label indications with no duration limits.  That means meat producers can use these drugs continuously, which would further increase drug-resistant bacteria. There are few instances in human medicine where such use would be appropriate. We should apply the same standard to animal medicine and farming.

We urge you to take the opportunity with the ADUFA reauthorization to establish duration limits for all medically important antibiotics for use in food animal production that do not exceed 21 days.

Doing so will help ensure that we’re able to treat infections and save lives.

Sincerely,

The Health Professionals Action Network 

Anthony D. So, MD, MPA

Professor of the Practice, Department of International Health

Johns Hopkins Bloomberg School of Public Health*

Baltimore, MD

Sameer Patel, MD

Pediatric Infectious Diseases Physician 

Chicago, IL 

Tara Smith, PhD

Infectious Diseases Epidemiologist

Kent, Ohio  

Anand Gourishankar, MD, M.R.C.P.

Pediatric Hospitalist, Houston, Texas.

Matthew Ferreira, DVM, MPH

University of Chicago, Department of Medicine

Chicago, IL

Sujit Suchindran, MD

Infectious Disease Physician 

Burlington, MA

*Institutional affiliation is for identification purposes only, not implying institutional endorsement

Clinician Champions in Comprehensive Antibiotic Stewardship 

Saul R. Hymes, MD

Medical Director of Pediatric Antimicrobial Stewardship

Stony Brook Children's Hospital

Stony Brook, NY

Scott Weissman, MD

Medical Director, Antimicrobial Stewardship Program

Seattle Children’s Hospital, Seattle, WA

Jason G. Newland, MD, Med

Director, Antimicrobial Stewardship Program 

St. Louis Children’s Hospital

St. Louis, MO

Stacia Clinton, RD, LDN

National Program Director, Healthy Food in Health Care 

Health Care Without Harm