APUA campaign to support FDA ban on cephalosporins

On January 4, 2012, FDA issed an order of prohibition on certain extralabel uses of cephalosporin drugs in cattle, swine, chickens, and turkeys, to become effective April 5, 2012. FDA took this action to preserve the efficacy of cephalosporin drugs for treating human disease, including pneumonia, septicemia, meningitis, and infections of the urinary tract, bones, and upper respiratory tract. Cephalosporins are used against life-threatening infections and are considered drugs of last resort for people with sever foodborne illness. They are also the only class of antibiotic that carry no warnings against use in children or immunocompromised patients. With the exception of cephapirin (an older antibiotic drug not believed to contribute significantly to antibiotic resistance), the prohibited uses of cephalosporins included:

  1. Use at unapproved doses, frequencies, durations, or routes of administration,

  2. Use in species or production classes outside the ones specifically designated on the label, and

  3. Use for disease prevention.

The re-issuance of the ban marked a victory for The Pew Charitable Trusts, APUA, and other stakeholder organizations that advocated for the order of prohibition when it was first announced in 2008. At the time, the order was revoked in response to criticism from the food animal industry. In 2012, APUA joined Pew's nationwide campaign to rally support for the ban to ensure that it would not be revoked again. By the close of the comment period on March 6, APUA had gathered more than 30 personal letters of support from opinion leaders, experts, and Nobel laureates, as well as joint letters to FDA from the Council of State and Territorial Epidemiologists and the National Association of Public Health Veterinarians.

APUA articles published & research done on antibiotic use in food animals

"Restricting antimicrobial access in food animals: lessons from Europe" (Microbe June 2011)
"Food animals and antimicrobials: impacts on human health" (Clinical Microbiology Reviews October 2011)
"Antibiotics in the animals we eat" (The Scientist April 2012)

FAAIR (Facts about Antibiotics in Animals and their Impact on Resistance) I (Clinical Infectious DiseasesJune 2002): With support from the Joyce Foundation, APUA published a comprehensive report on the topic of antimicrobial use in agriculture and its risk to human health through 1) direct and indirect transfer of resistance through food chains and ecosystems, and 2) the cumulative effects of the dissemination of antimicrobial resistance in the environment. The FAAIR Scientific Advisory Panel was convened from experts in various fields of research and medicine, and developed consensus conclusions and policy recommendations based on the data from over 500 published studies. The FAAIR report has been cited by the Institute of Medicine, used as evidence in the FDA ban on enrofloxacin in poultry and the FDA ban on using fluoroquinolones as growth promoters, and served as the scientific basis for the McDonald's Corporation ban on certain antibiotics as growth promoters.

FAAIR II (Preventive Veterinary Medicine, February 2006): With support from the Joyce Foundation, APUA published a comprehensive report on the need for improved antimicrobial use data collection in food animal production in the U.S., to better guide regulatory decision-making. The FAAIR II expert panel was comprised of expert representatives from academia, public interest groups, veterinary professional associations, public health agencies, food producer organizations, and the pharmaceutical industry.

ROAR (Reservoirs of Antibiotic Resistance) project (2002-2007): With funding from the National Institute of Allergy and Infectious Diseases, APUA initiated an unprecedented effort to improve scientific understanding of the role of commensal (normally harmless and enteric) bacteria in the spread of antimicrobial resistance, using statistical, risk analysis, and mathematical modeling techniques.

APUA meetings with stakeholders and policymakers

"Improving Antimicrobial Use in Food Animal Production: Alternatives, Options, and Incentives"(Washington, DC, May 6-7, 2012):
With the generous support of The Pew Charitable Trusts, APUA hosted a forum for open discussion to promote judicious use of antibiotics, in order to both preserve their efficacy to treat disease and ensure a safe, stable, and affordable food supply. The objectives of the event included: 

  • To evaluate feasible alternatives to current non-therapeutic/preventive antimicrobial use in food animal production, specifying barriers and opportunities;

  • To propose incentives to promote improved practices and so minimize the need for use of antimicrobials;

  • To propose an action plan, based on identified solutions.

"The EU Ban on Use of Antibiotics for Growth Promotion in Agriculture: Review of Scientific Evidence and Implications for Public Health" (Paris, May 29, 2010):
With the generous support of The Pew Charitable Trusts, APUA hosted a roundtable meeting in Paris to 1) discuss the EU and individual country bans on the use of antibiotics for livestock growth promotion, 2) review EU and individual country policies and processes involved in implementing the ban, and 3) consider ways to respond to and comment on arguments from U.S. industry that the European ban has been a failure.

"Restricting antimicrobial access in food animals: lessons from Europe" (Microbe June 2011)

 

Delegates to the roundtable from the U.S. and ten European countries

Grantmakers in Health issue dialogue on antibiotic resistance and systemic contaminants (Washington D.C., October 3, 2000):
Dr. Stuart B. Levy (APUA President) presented at a day-long issue dialogue held by Grantmakers in Health (GIH) and the Health and Environmental Funders Network (HEFN) addressing factors such as 1) the insufficient safeguards in manufacturing and agriculture, 2) increased waste products and lack of suitable disposal methods, 3) the dearth of rigorous research and surveillance, and 4) the overuse and misuse of antibiotics that all contribute to low levels of chronic exposure to antibiotics that adversely impact human health.

"Antibiotic Use in Food Animals: A Dialogue for a Common Purpose" (Chicago, Oct. 26-27, 2011):
Carol Cogliani (APUA Program Manager) represented APUA at the NIAA (National Institute for Animal Agriculture) symposium in Chicago. The symposium sought to promote dialogue on the subject of “One Health: healthy people, healthy animals, healthy food.” 13 animal health and human health scientists were invited to speak on four main topics: 1) human health implications relative to antibiotic use, 2) regulatory oversight and risk mitigation, 3) livestock-associated MRSA (understanding and communicating the risks), and 4) connecting with consumers.

"Improving Antimicrobial Use in Food Animal Production" (Washington D.C., May 6-7, 2012):
With the generous support of The Pew Charitable Trusts, APUA held a national stakeholder meeting in Washington D.C. to promote open discussion among major groups in the food industry. The goals of the meeting were to evaluate feasible alternatives to the current non-therapeutic use of antibiotics in food animal production, propose incentives to promote the voluntary use of alternatives, and draw up an action plan to implement the incentives.

APUA involvement in sign-on letters and petitions

Letter from The Pew Health Group and co-signers to Congress on “Sound Science: antibiotic use in food animals leads to drug resistant infections in people” (September 6, 2011)

  • Objected to recent statements that had been made on the House floor suggesting that there was not enough “hard” scientific evidence to link antibiotic overuse in animals with antibiotic resistance in humans. Cited numerous peer-reviewed scientific journal articles and testimony from federal, domestic, and international health organizations.

  • Sent to: both houses of Congress, DHHS, FDA, USDA, CDC, Executive Office of the President

  • Signing organizations also listed on an ad that ran in Politico, CQ Today, Roll Call, The Hill

  • APUA gathered individual signatures in support of letter at 51st ICAAC (9-18-11) and 49th IDSA (10-20-11)

Letter from The Pew Health Group and co-signers to the Honorable Thomas Vilsack, Secretary of the USDA(October 18, 2011)

  • Expressed concern at the USDA’s noncommittal response to the Government Accountability Office’s report and the growing body of scientific literature that agree that routinely giving important human antibiotics to food animals contributes to antibiotic resistance.

  • Sent to: Secretary and Under Secretary of the USDA

“We the People” petition by The Pew Health Group and co-petitioners on WhiteHouse.gov (March 16, 2012)

  • Pressured the Obama administration and the FDA to finalize draft Guidance #209 as a first step in limiting injudicious antibiotic use in food animals.

Letter from STOP Foodborne Illness and co-signers to the Honorable Margaret Hamburg, Commissioner of the FDA (April 30, 2012)

  • Urged FDA not to appeal the court’s first decision when the NRDC filed a lawsuit against the FDA, in which the court required the FDA to enforce a ban on penicillin and tetracyclines being used as feed additives for healthy animals (a ban first proposed in 1977 but ignored until 2011).

  • Sent to: Commissioner of the FDA

Letter from The Pew Health Group and co-signers to the Honorable Margaret Hamburg (June 27, 2012)

  • Requested that the FDA accelerate and expand actions to stop the overuse and misuse of life-saving antibiotics on industrial farms. Urged closing of loopholes and inclusion of improvements to strengthen Guidance for Industry #209, #213, and the Veterinary Feed Directive.

  • Sent to: Commissioner of the FDA

Letter from Keep Antibiotics Working and co-signers to the FDA (July 11, 2012)

  • Recommended that draft Veterinary Feed Directive language should still require a valid veterinarian-client-patient relationship and retention of receipt and distribution records (for feed containing VFD drugs), and include requirements for feed distributors to report drug use data.

  • Sent to: Division of Dockets Management of the FDA

Letter from the Institute for Agriculture and Trade Policy to the Honorable Margaret Hamburg, Commissioner of the FDA (July 13, 2012)

  • Urged FDA not to appeal the court’s second decision in the NRDC vs. FDA lawsuit, in which the court required the FDA to enforce bans on other medically important classes of drugs being used in animal feed, such as streptogramins, sulfas, aminoglycosides, and macrolides.

  • Sent to: FDA, Center for Veterinary Medicine