359 Health Professionals Ask FDA to Better Protect Antibiotics

359 Health Professionals Ask FDA to Better Protect Antibiotics

Docket No. FDA-2011-D-0889 (Draft Guidance 213)
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

Dear Dr. William T. Flynn,

On behalf of the patients and communities we serve, we are writing to respectfully request that the federal government accelerate and expand actions to curtail the overuse and misuse of antibiotics in food animal production. FDA should act on recent court orders to comply with the law's mandate to protect public health from risky uses of antibiotics in animal agriculture and improve its proposed Guidance package (Guidance for Industry No. 209, Guidance for Industry No.213, and Veterinary Feed Directive) in parallel.

Data compiled by the U.S. Food and Drug Administration (FDA) demonstrates that 80 percent of all antibiotics sold in the United States are for food animal production, the vast majority used to compensate for overcrowded and unsanitary conditions and fed to animals for growth promotion rather than any therapeutic need. This contributes to a surge of drug-resistant bacteria, called “superbugs”, which can easily make their way out of the farm and spread to humans through infected food, water, and other pathways, putting the health of all Americans at risk for dangerous antibiotic-resistant infections.

Four decades ago, experts began sounding the alarm about these practices. The Centers for Disease Control and Prevention, the FDA, and U.S. Department of Agriculture have all testified before Congress that scientific studies link the routine, non-therapeutic uses of antibiotics on industrial farms and the crisis of antibiotic resistance in humans. Medical and public health institutions have long warned about the dangers of such uses and have called for action. Yet despite the overwhelming scientific evidence about the threat to human health, the routine use of low-dose antibiotics in intensive meat and poultry operations continues unabated and the crisis of antibiotic resistance has grown.

The use of life-saving antibiotics for disease prevention should be a last resort, when all other options have failed, and should not substitute for improved management practices on livestock farms. The medical community is actively working on reducing the inappropriate use of antibiotics in human medicine and has made progress on that front. We now call on FDA and other federal agencies to do their part and take strong action in the interest of the American people to preserve the effectiveness of the vital medicines we depend upon to treat common but dangerous infections.

Rulings by a federal court in New York from March and June of this year have directed the FDA to carry out withdrawal proceedings for penicillin and tetracyclines and to evaluate the safety of using other medically important antibiotics in animal feed. FDA should move ahead with this important process and not replace enforceable limitations on antibiotic use with voluntary guidance.

As a supplement to the actions required by the court, FDA's proposed Guidance package has the potential to help eliminate non-therapeutic uses of antibiotics and ensure more rigorous veterinary oversight of antibiotics used in food animal production, but significant revisions will need to be made.

We hope FDA will act quickly and vigorously to:

  • Comply with recent court orders directing the agency to move forward with the process for mandatory regulations to stop the use in animal agriculture of all antibiotics important for human medicine, unless those uses can be proven safe.
  • If it chooses to continue in parallel with a voluntary approach, revise its guidance to eliminate loopholes that would allow livestock operators to continue the practice of administering herd-wide or flock-wide doses of antibiotics to animals that are not sick, even if operators call this practice “disease prevention.”
  • Establish a monitoring program to collect the information from industry needed to evaluate antibiotic use trends, prevalence of high risk practices and incidence of drug resistance.

The development of antibiotics, which have been called “miracle” drugs, represented a huge step forward in human medicine. Now vigilance and strong action is required by FDA to safeguard the effectiveness of these life-saving medicines for when we need them most. Effective FDA leadership on this issue can have huge benefits: healthier meat and poultry products, the elimination of unnecessary suffering and health care costs, and saved lives.


Jerry Abajian, CA
Susan Bagby, OR
Anne Berry, Cabin Creek Health Systems, WV
Deborah Boggs, The Hebrew Home.org, MD
Alice Cary, CA
Jason Chao, OH
Kevin Chatham-Stephens, NY
Amy Collins, MetroWest Medical Center, MA
John Curtiss, Arizona, AZ
Jill Denny, WA
Arthur D'Harlingue, CA
Paul Duffey, ACP, AZ
Amar Duggirala, Poolesville Family Practice, MD
William Fay, MO
Douglas Gerstein, CA
Timothy Goltz, Lincoln Medical Partners, ME
Robert Gould, Physicians for Social Responsibility, CA
Richard Grady, University of Washington, WA
Thomas Hall, CA
Andy Harris, OHSU, OR
Everett Hart, MD
Trudy Hartman, CA
Schuyler Hilts, American College of Physicians, AZ
Allen Holloway, AZ
Casey Jackson, CA
William H. Johnson, Kidney Center of Frederick and Hagerstown, MD
James Koss, MobileMD, CA
Joan Lee, Frederick Memorial Hospital, MD
Beverly Leite, WA
Cynthia Li, CA
Andrea McCUllough, CA
James Melloh , ME
Gerard Mullin, Johns Hopkins, MD
Ray Nicola, WA
Stephen Plank, CA
John Schlicher, AZ
Annamalai Senthilkumar, MO
Carolyn Shuman, CA
Gary Spivey, AZ
MaryKelly Sutton, Raphael Medicine & Therapies, CA
Cal Thompson, MD
Trula Thompson, AAFP, WA
Dorothy Vura-Weis, CA
Barbara Warren, PSR Arizona, AZ
Mark Wille, CA
Anne Yoshino, AZ

Ida Aiken, MGH, MA
Rosemarie Allen, PA
Connie Anderson, WA
Sue Ashton, Winnebago County/Oshkosh Housing Authority, WI
Laura Bankert, FMH, MD
Carol Barker, FMH, MD
Mary Bartholet, Retired faculty member, WA
Nancy Berry, PA
Jeanie Birchall, WA
Mary Jo Borden, University of Wisconsin, Madison, WI
Noelani Bouchard, HI
Marlyn Bradshaw, PA
Patricia Brand, MD
Elaine Bundy, University of Maryland, MD
Charon Burda, MD
Margaret Burns, UMMS, MD
P Carls, IA
Cheryl Cioffi, Frederick Regional Health System, MD
Melanie Coffman, Head Start, MA
Susan Connolly, University of Maryland Medical System, MD
Matthew Czaga, MONE, MD
Deborah Deak, Carroll Hospital Center, MD
Mary Dennison, WA
Helen Dickison, Frederick Memorial Hospital, MD
Megan Doede, MD
Shelley Done, FL
Lori Edwards, Frederick Memorial Hospital, MD
Hilke Faber, WA State Nurses Assoc., WA
Dena Ferrell, NC
Stephanie Finn, Children's Healthcare of Atlanta, GA
Judith Focareta, Magee-Womens Hospital, PA
Theresa Fowler, Doernbecher Children's Hospital, OR
Sandra Glenn-Vernon, Nemours, DE
Heather Gunther, MD
Jeanne Gurda, WI
Joseph Guss, NY
Linda Hageman, TN
Jennell Hedges, MD
Stephanie Hensley, MD
Joni Hensley, WA
Grace Hudak, MageeWomens Hospital, PA
Katie Huffling, Alliance of Nurses for Healthy Environments, MD
Judith Huntington, Washington State Nurses Association, WA
Lori Isaacs, Winnie Palmer Hospital, FL
Claudette Jacobs, HCGH, MD
Suzanne Jacobson, Frederick Regional Health System, MD
Donna Jordan, Carolinas Health Care System, NC
Jane Kapustin, Univ of MD Baltimore SON, MD
Allison Kellenberger, University of Missouri Columbia Hospital, MO
Heather Keller, St. Joseph Medical Center, MD
Maggie Kennedy, AK
Bettie Kettell, ANA, AORN, ME
DIane Krassenstein, Federal Occupational Health, PA
J Kulvinskas, Evergreen Health, WA
Maureen Lusch, PPAOHN, PA
Lisa Lagowski, MD
Diane Lamm, WI
Glenna Langley, Montgomery community College, MD
Hermine Levey Weston, Practice Greenhealth, MA
Cheryl Lewis, CA
Lauren Malatz, Frederick Memorial Hospital, MD
M C Mark, FL
Linda McAuliffe, AWHONN, CA
Susan Mitchel, MN
Richard Moore, 514th ASTS, JBMDL, NJ
Kathleen Morris, Ohio Nurses Association, OH
Jim Overton, WA
Lisa Pahl, PA
Jan Path, Tomah Memorial Hospital, WI
Laurie People's, Berkeley Health Department, CA
Elizabeth Phelps, SMHC, MD
Margaret Podio, Frederick Memorial Hospital, MD
Janet Primomo, University of Washington, WA
Maryanne Reimer, Frederick Memoria Hospital, MD
Helene Richards, Be Mindful Farm, VA
Claudia Rodriguez Zinn, AK
Sheliah Roth, PRMCE, WA
Marie Sandy, MI
Miller Sherling, Seattle University, WA
Suzanne Smallwood, Frederick Memoria Hospital, VA
Linda Smith, CA
Claudia Smith, Alliance of Nurses for Healthy Environments, MD
Gail Sonnenberg, Frederick Regional Healthcare System, MD
Patricia Stafford, MD
Mary Thomas, Health Care Without Harm, WA
Kathleen Trosch, Magee Womens Hospital, PA
Hermien Watkins, WA
Jane Welch, Anne Arundel Medical Center, MD
Lisa Whatley, Evergreen Health, WA
Kathleen Whitefield, Cruical Productions Unlimited, CA
Kathleen Williams, Frederick Memorial Hospital, MD
Martha Wilson, MD
Shellye Winters, MD

Christine Baca, Kaiser Permanente, CA
Gail Baptiste, MD
Nach Bhangal, CA
April Boyle, CA
Christa Byrd, MI
Carla Caccia, NC
Patty Campbell, John Muir Health, CA
Dawn Cascio, The Valley Hospital, NJ
Holly Emmons, Union Hospital of Cecill County, MD
Heidi Fernandez, , CA
David Folio, MD
Marianna Gabriel, CA
Joyce Geer, MD
Maria Goglia, MD
Michelle Goodrow, CA
Anders Grant, CHC, MD
Jaclyn Harhart, St. John's Regional Medical Center, CA
Irana Hawkins, MA
Melinda Hemmelgarn, Food Sleuth, LLC, MO
Janet Hiser, Morrison, CT
Kate Hogan, Mt. Washington Pediatric Hospital, MD
Carol Holman, Marquette General Hospital, MI
Lezly Hughes, PTHA, WA
Kathleen Isbell, Kaiser Permanente, CA
Kull Laura, Madonna University, MI
Victoria Lee, CO
Maureen Leser, MD
Bonnie Maddex, St John's Medical Center, WY
Beth Marcondes, University of Washington Medical Center, WA
Alyssa Nathanson, Vermont Fresh Network, VT
MIchele Nikolai, Sparrow, MI
Katharina Pesquera, KPMAS, MD
Paula Pini, The Valley Hospital, NJ
Shari Pollack, Jesse Brown VA Medical Center, IL
Melissa Rosenberg, Health Care Without Harm, FL
Colleen Ross, CA
Nancy Saal, MA
David Schwartz, Hospital, MI
Emily Schwartz, St. John Providence Health System, MI
Andrea Schwartz, CA
Lamis sleiman, North shore Medical Center, MA
Lisa Smith, St. John's Medical Center, WY
Erica Stevens, MA
Joan Todd, Northwest Hospital, MD
Sarah Trist, MSDE, MD
L. E. Trudeau, MI
Carole Vecchry, North Sshore Medical System, MA
Anita Widmayer, Kaiser Permanente, CA

Other Health and Health Care Professionals
Samantha Anderson, Ready Hands Home Care, VA
Steven Arn, KS
Natasha Arutyuntyans, NY
Dierdre Asgar, NJ
Rachael Aubin, CA
Susan Bailey, Lexington School District One, SC
Daniel Barnette, MD
Joan Barrett, SC
Robin Bjorge, Kaiser Permanente, CA
Crystal Bolte, CA
Shaun Bopp, WA
Mike Brake, AZ
Mark Brockway, Evergreen Health Care, WA
Lara Campagna, NC
Paula Canfield, St. Francis Hospital, SC
Juan Carlos, CA
Donald Carr, CA
Marie Ciaffa, NJ
Martin Clifford, IN
Richard Coan, AZ
Dana Craig, AL
Nan Crockett, MD
John Cunningham, CA
Blake Cushing, AE
Chelsea Davis, Northwest Veg, OR
Michael Dees, FL
Rachele DeLorenzo, CT
Margaret DeMott, CA
Rachel DeMunda, Providence Hospital, DC
Alan Dougherty, FL
Beth Douglas, TN
Leslie Dovey, PA
Mattisa Dumas, TX
Thomas Evans, CO
Christina Fetzko, MD
Nicole Field, CA
Amanda Fitzsimmons, AZ
Aaron Floyd, WA
Jeff Francis, AL
Colleen Funkhouser, HCWH, VA
Eugene Gallo, TX
Matthew Garriga, UT
David Gillum, OH
Mary Goodkind, NC
Alisha Gory, CA
Reba Granger, United Blood Services, LA
Bert Greenberg, CA
Danielle Grove, MD
Jodie Hagan, OR
Sue Hahm, WA
Susan Harris, CA
Rebecca Harris, MI
Barb Haskell, Blue Hill Memorial Hospital, ME
MJ Hebert, MI
William Helton, AP
UChong Helton, AP
Darrel Hendricks, WI
Liza Hernandez, NM
Carol Heyen, CA
Lin Hill, PGH, NH
Andie Hoehn, CA
Brenda Hoppe, Oregon State University, OR
Blair Hughes, Frederick Memorial Hospital, MD
J. Huston, Farm to Table Food Services, CA
Mark Hutson, Gundersen, WI
Susan Jannetto, AZ
David Jesson, CA
Christopher Johnson, United General Hospital, WA
Jessica Johnson, FMH, MD
Martina Jones, KY
Phil Jore, ND
Terry Kennedy, TN
Zorayda Klyne, NJ
Lisa Koleszar, Wildtree, VA
Pat Lacey, PA
Jane Lackey, Fenter Physical Therapy, AR
Mary Lamielle, National Center for Environmental HealthStrategies, NJ
Monica Lawson, OR
Pamela Lazo, CA
Edward Lindemann, MD
Danielle Lino, FL
Lee Lipp, CA
Sarah Lolley, MO
Jason Loucks, WI
Mark Love, OK
Gina Lynnes, CO
Richard Mafong, GA
Elena Malishkin, CO
Joanna Manesajian, CA
Brooke Mathe, Kaiser Permanente, CA
Roger Matherly, CO
Lama Mault, AZ
Peggy McCorkle, TX
Mike McCormick, TX
James Michelle, FL
Anna Michels, TX
Daniel Miller, UCSF Mededical Center, CA
Regina Minniss, MD
Jan Minnix, VA
Doug MInnix, VA
Dianne Moore, MooreBetterFood, PA
Mui Myers, MO
Angela Myers, OR
Sandra Nunez, LA
Steve Olsen, S and R Consulting Associates, ID
Mike Palmer, AR
Matthew Paoletti, TX
Juanita Perez, TX
Jose Perez, TX
Sarah Petrie, WA
Craig Phillips, Metz Culinary Management, PA
Marj Plumb, PSR SF Bay Area, CA
Robert Pound, CA
Jessica Preiss, OR
Faryal Qureshi, Frederick Memorial Hospital, MD
Donnita Raetz, KS
Sara Reid, Evergreen Healthcare, WA
Lee Ritenour, AL
Stephen Robertson, MO
Charles Robertson, SafeBond, GA
Robert Rosenberg, CA
James Sand, Frederick Memorial Hospital, MD
Setsuko Sasaki, MA
KImberly Schaub, IL
kevin schmier, AZ
Joshua Scholtes, PA
Debra Schyllander Bass, Brooke Grove Foundation, MD
Rachel Seguin, OH
Myra Shepard, SC
Lynne Shugart, DE
Dana Slade, MN
Charlotte Smith, PharmEcology Services, WM Healthcare Solutions, WI
Andrew Smith, WA
Diane Snow, CA
Lisa Soria, NC
Paula Spellerberg, Frederick Memorial Hospital, MD
Jason Stanford, MD
Bruce Stangeland, CA
Michael Stevens, TX
Jennifer Stevens, Frederick Memorial Hospital, MD
David Stewart, Army Medical Command, TX
Priscilla Stubblefield-Cory, CA
Pamela Sue, AK
Sara Syer, CA
Tracey Thomas, IN
Patty Thomas, CA
Tom Thompson, Gundersen, WI
Sapna Thottathil, San Francisco Bay Physicians for Social Responsibility, CA
John Traceski, NM
Frederick Turner, GA
Jen Vachris, AL
Anthony Vachris, AL
Daniel Vieira, NJ
Christian Vilas, LA
Lisa Webster, GA
Don Whisnant, CA
Caitlin Wightman, MO
Stephen Wightman, MO
Emily Williams, Frederick Memorial Hospital, MD
Flint Wilson, IA
Dorota Woodbury, FL
Nicholas Woods, NE
Ann Wright, SC
William Wright, Sebasticook Valley Health, ME
Jenna Young, NC
William Zahuranec, WV
V Zahuranec, WV
Diana Zahuranec, WV
Catherine Zimmer, Zimmer Environmental Improvement LLC, MN
Laura Hassett, FMH, MD
Lucy Shamash, FMH, MD

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