The FDA’s Role in Public Health

by Madison Green | Apr 8, 2021 | FDA, Healthcare, Medical Devices, Pharma, Regulatory

FDA and the important role they play in medical devices and pharmaceuticals and public health

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 Human Services (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 known as 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.⁴Vaccines 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!

¹WHO (n.d.) Public Health Services retrieved on 04/04/2021 from: https://www.euro.who.int/en/health-topics/Health-systems/public-health-services

²Hamburg, 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

³FDA (March 2021) Expanded access retrieved on 04/04/2021 from: https://www.fda.gov/news-events/public-health-focus/expanded-access

⁴Abram, FDA (July 2018) Protecting and Promoting Public Health: Advancing the 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

⁵United States v. Bacto-Unidisk, 394 U.S. 784 (1969). (Accessed May 21, 2009, at http://supreme.justia.com/us/394/784/case.html)

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.