July 10, 2013
Divisions of Dockets Management, HFA – 305
Food and Drug Administration, HHS
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
To Whom It May Concern:
As a microbiologist and a concerned individual, I request your administration to address the food animal antibiotic epidemic by initiating more drastic actions. “While Guidance 213 is a step in the right direction, as a voluntary measure limited in scope, it does not do enough to protect the American people. Research has clearly shown that feeding low doses of antibiotics to healthy animals contributes to the rise of antibiotic-resistant bacteria. Guidance 213 addresses antibiotic use for the purposes of growth promotion, but not disease prevention. Both of these types of use can lead to antibiotic resistance. We are concerned that in the absence of stronger definitions of inappropriate use, the underlying problem of drug resistance will not be fully addressed” (Members of Congress). I along with multitudes of scientists and health care professionals, request more transparency. Guidance 213 presents itself to be vague and needs to address the following:
“1) It must clearly limit the use of antibiotics for “disease prevention” in animals. “Disease prevention” is often a catch-all term covering many uses in the absence of clinical disease. The Guidance should provide a more restrictive definition to ensure appropriate use of antibiotics.
2) It should include a plan to monitor progress in reducing antibiotic use and antibiotic resistance. Data collection on antibiotic use is virtually non-existent, and data on antibiotic sales is insufficient to measure the effectiveness of the guidance program” (Health Professionals Letter).
3) “Guidance 213 should include an evaluation plan that incorporates goals for anticipated reductions in antimicrobial use and levels of resistance in monitored bacteria along with potential actions to be taken if goals are not met” (Members of Congress).
It is unethical to conceal and neglect further research on such a potent issue. Drug-resistance is a significant issue, which can certainly affect human health and the ability to recover in the future. Drug manufacturers, veterinarians, and livestock farmers have no economic interest to alter antibiotic production and sales and that is why it is vital for the FDA to take more surveillance and reporting initiatives. I hope you fortify your policies in a timely manner to eliminate ill-advised use of drugs in the agricultural industry. Furthermore, I request this administration to efficiently report food animal antibiotic sales, distribution, dosage, and container size to demonstrate current use patterns, explain resistance, and track progress. Not only should all of the data be reported, but an efficient antimicrobial data collection strategy needs to be established and clearly presented as well. These efforts will provide insight on the efficiency of public health programs. Again, I ask you to quickly revise and finalize the Guidance for Industry 213 while addressing the issues presented in this letter. We need your help and we need to protect our future generations from the harmful effects of antibiotic resistance.
Sincerely,
Dr. Glenn Morris
Microbiologist
Total Word Count: 497
My Words: 272
DISCLAIMER: Parts of this website are fictional and were created for a class. Please email my instructor with questions: [email protected].
Divisions of Dockets Management, HFA – 305
Food and Drug Administration, HHS
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
To Whom It May Concern:
As a microbiologist and a concerned individual, I request your administration to address the food animal antibiotic epidemic by initiating more drastic actions. “While Guidance 213 is a step in the right direction, as a voluntary measure limited in scope, it does not do enough to protect the American people. Research has clearly shown that feeding low doses of antibiotics to healthy animals contributes to the rise of antibiotic-resistant bacteria. Guidance 213 addresses antibiotic use for the purposes of growth promotion, but not disease prevention. Both of these types of use can lead to antibiotic resistance. We are concerned that in the absence of stronger definitions of inappropriate use, the underlying problem of drug resistance will not be fully addressed” (Members of Congress). I along with multitudes of scientists and health care professionals, request more transparency. Guidance 213 presents itself to be vague and needs to address the following:
“1) It must clearly limit the use of antibiotics for “disease prevention” in animals. “Disease prevention” is often a catch-all term covering many uses in the absence of clinical disease. The Guidance should provide a more restrictive definition to ensure appropriate use of antibiotics.
2) It should include a plan to monitor progress in reducing antibiotic use and antibiotic resistance. Data collection on antibiotic use is virtually non-existent, and data on antibiotic sales is insufficient to measure the effectiveness of the guidance program” (Health Professionals Letter).
3) “Guidance 213 should include an evaluation plan that incorporates goals for anticipated reductions in antimicrobial use and levels of resistance in monitored bacteria along with potential actions to be taken if goals are not met” (Members of Congress).
It is unethical to conceal and neglect further research on such a potent issue. Drug-resistance is a significant issue, which can certainly affect human health and the ability to recover in the future. Drug manufacturers, veterinarians, and livestock farmers have no economic interest to alter antibiotic production and sales and that is why it is vital for the FDA to take more surveillance and reporting initiatives. I hope you fortify your policies in a timely manner to eliminate ill-advised use of drugs in the agricultural industry. Furthermore, I request this administration to efficiently report food animal antibiotic sales, distribution, dosage, and container size to demonstrate current use patterns, explain resistance, and track progress. Not only should all of the data be reported, but an efficient antimicrobial data collection strategy needs to be established and clearly presented as well. These efforts will provide insight on the efficiency of public health programs. Again, I ask you to quickly revise and finalize the Guidance for Industry 213 while addressing the issues presented in this letter. We need your help and we need to protect our future generations from the harmful effects of antibiotic resistance.
Sincerely,
Dr. Glenn Morris
Microbiologist
Total Word Count: 497
My Words: 272
DISCLAIMER: Parts of this website are fictional and were created for a class. Please email my instructor with questions: [email protected].