Running Head: FOUNDATIONS OF COMMUNITY HEALTH – FDA
Foundations of Community Health – FDA
Lindsay Ann Abrigo
Dr. Kimberly Brodie
MPH 585 – Community Health
March 1, 2014
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FOUNDATIONS OF COMMUNITY HEALTH – FDA
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The Food and Drug Administration (FDA), a government health agency within
the U.S. Department of Health and Human Services (HHS), is responsible for overseeing
and protecting the health of the public by “assuring the safety, efficacy, and security of
human and veterinary drugs, biological products, medical devices, [the] nation’s food
supply (that it is safe, wholesome, sanitary, and properly labeled), cosmetics, and
products that emit radiation” (FDA, 2013), many of which are distributed across state
lines (Schneider, 2011, p. 30). According to Schneider, it is more efficient and
economical to be “bound by uniform national rules rather than having to comply with
fifty different sets of state regulation” (2011, p. 30). The FDA is the oldest
comprehensive consumer protection agency in the U. S. federal government (FDA,
2013). The FDA’s modern regulatory functions began with the passage of the 1906 Pure
Food and Drugs Act that prohibited interstate commerce in adulterated and misbranded
food and drugs (FDA, 2013). Since 1906, the FDA and its responsibilities have
undergone much change just as the “sciences undergirding the products the agency
regulates, and the social, cultural, political, and economic changes that have formed the
context for these developments, all have witnessed disruptions over the past century”
(FDA, 2013). Yet the core public health mission of the FDA has remained the same today
as it was then.
The FDA consists of the Office of the Commissioner and four directorates that
oversee the core functions of the agency including 1) Medical Products and Tobacco, 2)
Foods and Veterinary Medicine, 3) Global Regulatory Operations and Policy, and 4)
Operations (2014). The FDA contributes to the advancement of the public’s health by
helping to speed innovations that make medicines and foods more effective, safer, and
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more affordable, while also ensuring that the public receives the accurate, science-based
information they need to use medicines and foods to maintain and optimize their health
(APHA, 2014; FDA, 2013). In addition, the FDA holds a significant role in the nation’s
counterterrorism capability by safeguarding “the security of the food supply and by
fostering development of medical products to respond to deliberate and naturally
emerging public health threats” (FDA, 2013).
The three core functions of public health, as described by Schneider (2011),
include:
1. Assessment – Monitor health status to identify community health problems;
Diagnose and investigate health problems and health hazards in the community
2. Policy development – Inform, educate, and empower people about health issues;
Mobilize community partnerships to identify and solve health problems; Develop
policies and plans that support individual and community health efforts
3. Assurance – Enforce laws and regulations that protect health and ensure safety;
Link people to needed personal health services and assure the provision of health
care when otherwise unavailable; Assure a competent public health and personal
healthcare workforce; Evaluate effectiveness, accessibility, and quality of
personal and population-based health services (Schneider, 2011).
These core functions can be identified within the FDA’s responsibilities and the
contributions made by the agency to meet the goals for Healthy People 2020.
A topic of the Healthy People 2020 initiative that the FDA contributes to is food
safety. The goal of Healthy People 2020 is to “improve food safety and reduce foodborne
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illnesses” (2013). According to Healthy People 2020, the objectives for food safety
include:
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Reducing infections cause by key pathogens transmitted commonly through food
Reduce the number of outbreak-associated infections due to E. coli,
campylobacter, listeria, or salmonella species associated with food commodity
groups
Prevent an increase in the proportion of nontyphoidal salmonella and
campylobacter jejuni isolates from humans that are resistant to antimicrobial
drugs
Reduce severe allergic reactions to food among adults with a food allergy
diagnosis
Increase the proportion of consumers who follow key food safety practices
Improve food safety practices associated with foodborne illness in foodservice
and retail establishments (2013).
The FDA established the Coordinated Outbreak Response and Evaluation
(CORE) Network in 2011 to help federal, state, and local food safety regulatory and
public health partners address outbreaks (Zuraw, 2014). The FDA also modernized Good
Manufacturing Practices (GMPs), which would help protect against allergen crosscontact, develop improved methods for the accurate measurement of allergens in complex
foods, and table problematic food combinations as a means of focusing on reducing
severe allergic reactions to food (Zuraw, 2014).
Another topic of Healthy People 2020, Medical Product Safety, has an established
goal of “ensuring the safe use of medical products” (2013). The Medical Product Safety
objectives focus on overall improvement of patient treatment and appropriate use of
medical products, including drugs, biological products, and medical devices (Healthy
People 2020, 2013). The Healthy People 2020 objectives reflect strong scientific support
for safe use of medical products, which promotes better health among Americans (2013).
The five Medical Product Safety objectives as outlined by Healthy People 2020 include:
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Increase the proportion of health care organizations that are monitoring and
analyzing adverse events associated with medical therapies within their systems
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Increase the safe and effective treatment of pain
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Reduce the number of adverse events from medical products
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Increase the use of safe and effective medical products that are associated with
predictive biomarkers
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Reduce emergency department visits for common, preventable adverse events
from medications (2013).
Centers for Disease Control and Prevention identified the roles of the FDA in
relation to medical product safety, which includes providing premarket reviews,
postmarket surveillance, inspection, compliance, and enforcement on medical devices,
drugs, biologics, and radiological products (Koh, 2014).
References
American Public Health Association, (2014). APHA: Government health agencies.
Retrieved from website: http://www.apha.org/about/Public Health
Links/LinksGovernmentHealthAgencies.htm
Healthy People 2020. U.S. Department of Health & Human Services, (2013). Food
safety: Objectives. Retrieved from website:
http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=14
Healthy People 2020. U.S. Department of Health & Human Services, (2013). Food
safety: Overview. Retrieved from website:
http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicId=14
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Healthy People 2020. U.S. Department of Health & Human Services, (2013). Medical
product safety: Objectives. Retrieved from website:
http://healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=27
Healthy People 2020. U.S. Department of Health & Human Services, (2013). Medical
product safety: Overview. Retrieved from website:
http://healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicId=27
Koh, H. K. U.S. Department of Health & Human Services, Office of Disease Prevention
and Health Promotion. (2014). Prevention of foodborne illness and medical product
adverse events: A healthy people 2020 progress review. Retrieved from website:
http://www.cdc.gov/nchs/data/hpdata2020/hp2020_FS_and_MPS_progress_review_prese
ntation.pdf
Schneider, M. (2011). Introduction to public health. (3rd ed.). Sudbury, Massachusetts:
Jones and Bartlett Publishers.
U.S. Department of Health & Human Services, Food and Drug Administration. (2013).
About FDA: History. Retrieved from website:
http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm
U.S. Department of Health & Human Services, Food and Drug Administration. (2014).
About FDA: FDA fundamentals. Retrieved from website:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm
U.S. Department of Health & Human Services, Food and Drug Administration. (2013).
About FDA: What does FDA do?. Retrieved from website:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm
FOUNDATIONS OF COMMUNITY HEALTH – FDA
U.S. Department of Health & Human Services, Food and Drug Administration. (2013).
About FDA: What we do. Retrieved from website:
http://www.fda.gov/AboutFDA/WhatWeDo/default.htm
Zuraw, L. (2014, January 13). Healthy people 2020 reviews progress on food safety
objectives. Food Safety News. Retrieved from
http://www.foodsafetynews.com/2014/01/healthy-people-2020-progress/
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