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The FDA’s Role in Public Health
By: Madison Wheeler
Public health is generally defined as the health of the population as a whole. The World
Health Organization gives a more detailed definition as “the art and science of preventing
disease, prolonging life, and promoting health through the organized efforts of society”.1
Government agencies are part of those organized efforts, including the FDA.
The FDA is an agency within the Department of Health and HumanServices (DHHS)
that is responsible for over $2 trillion in medical products, food, and other consumer goods.2
Aside from being responsible for implementing and enforcing regulations that ensure consumer
goods are safe and effective for use, the FDA also has various programs that promote public
health. One of these crucial programs is the Expanded Access program, also knownas the
Compassionate Use program. This program provides a potential path for a patient with an
immediately life-threatening condition to gain access to an investigational drug, biologic, or
medical device that could help save their life.3
In addition to consumer programs, the FDA also promotes public health by facilitating
the development of safe and effective medical countermeasures, such as vaccines.4 Vaccines are
obviously a hot topic at this moment due to the ongoing COVID-19 pandemic. Thanks to the
FDA’s efforts, in addition to the frontline workers and scientists who worked tirelessly to bring
these vaccines to fruition, we are starting to see light at the end of the pandemic tunnel.
The United States Supreme Court once cited public health as the FDA’s “overriding
purpose”5 Since its inception in 1906, the FDA has continued its work to protect and promote
the public health of our nation. During this week, National Public Health Week, we are
especially grateful to all involved with ensuring public health priorities are upheld. EMMA
International plays a role in protecting public health by working alongside life science firms to
safely bring their product to market and ensuring compliance with sustainable solutions. Call us
at 248-987-4497 or email info@emmainternational.com to learn more about how we can help
your firm!
1 WHO (n.d.) Public Health Services retrieved on 04/04/2021 from: https://www.euro.who.int/en/health-
topics/Health-systems/public-health-services
2 Hamburg, MD., et al (2009) The FDA as a Public Health Agency retrieved on 04/04/2021 from:
https://www.nejm.org/doi/full/10.1056/NEJMp0903764
3 FDA (March 2021) Expanded access retrieved on 04/04/2021 from: https://www.fda.gov/news-events/public-
health-focus/expanded-access
4 Abram, FDA (July 2018) Protecting and Promoting Public Health:Advancingthe FDA’s Medical Countermeasures
Mission retrieved on 04/04/2021 from: https://www.fda.gov/news-events/fda-voices/protecting-and-promoting-
public-health-advancing-fdas-medical-countermeasures-mission
5 United States v. Bacto-Unidisk,394 U.S. 784 (1969).(Accessed May 21, 2009,at
http://supreme.justia.com/us/394/784/case.html)

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The FDA’s Role in Public Health

  • 1. The FDA’s Role in Public Health By: Madison Wheeler Public health is generally defined as the health of the population as a whole. The World Health Organization gives a more detailed definition as “the art and science of preventing disease, prolonging life, and promoting health through the organized efforts of society”.1 Government agencies are part of those organized efforts, including the FDA. The FDA is an agency within the Department of Health and HumanServices (DHHS) that is responsible for over $2 trillion in medical products, food, and other consumer goods.2 Aside from being responsible for implementing and enforcing regulations that ensure consumer goods are safe and effective for use, the FDA also has various programs that promote public health. One of these crucial programs is the Expanded Access program, also knownas the Compassionate Use program. This program provides a potential path for a patient with an immediately life-threatening condition to gain access to an investigational drug, biologic, or medical device that could help save their life.3 In addition to consumer programs, the FDA also promotes public health by facilitating the development of safe and effective medical countermeasures, such as vaccines.4 Vaccines are obviously a hot topic at this moment due to the ongoing COVID-19 pandemic. Thanks to the FDA’s efforts, in addition to the frontline workers and scientists who worked tirelessly to bring these vaccines to fruition, we are starting to see light at the end of the pandemic tunnel. The United States Supreme Court once cited public health as the FDA’s “overriding purpose”5 Since its inception in 1906, the FDA has continued its work to protect and promote the public health of our nation. During this week, National Public Health Week, we are especially grateful to all involved with ensuring public health priorities are upheld. EMMA International plays a role in protecting public health by working alongside life science firms to safely bring their product to market and ensuring compliance with sustainable solutions. Call us at 248-987-4497 or email info@emmainternational.com to learn more about how we can help your firm! 1 WHO (n.d.) Public Health Services retrieved on 04/04/2021 from: https://www.euro.who.int/en/health- topics/Health-systems/public-health-services 2 Hamburg, MD., et al (2009) The FDA as a Public Health Agency retrieved on 04/04/2021 from: https://www.nejm.org/doi/full/10.1056/NEJMp0903764 3 FDA (March 2021) Expanded access retrieved on 04/04/2021 from: https://www.fda.gov/news-events/public- health-focus/expanded-access 4 Abram, FDA (July 2018) Protecting and Promoting Public Health:Advancingthe FDA’s Medical Countermeasures Mission retrieved on 04/04/2021 from: https://www.fda.gov/news-events/fda-voices/protecting-and-promoting- public-health-advancing-fdas-medical-countermeasures-mission 5 United States v. Bacto-Unidisk,394 U.S. 784 (1969).(Accessed May 21, 2009,at http://supreme.justia.com/us/394/784/case.html)