DNP 840 Discuss two regulatory organizations that provide oversight within the health care delivery system

DNP 840 Discuss two regulatory organizations that provide oversight within the health care delivery system

Thank you for this throw back on history, the original Pure Food and Drugs Act was passed by Congress in 1906 and signed by President Theodore Roosevelt. The law, which prohibited misbranded and adulterated foods, drinks, and drugs in interstate commerce, was enforced by the Bureau of Chemistry in the Department of Agriculture. The bureau became the Food and Drug Administration in 1930.

The lack of regulation was not much of a concern during the early years of the country, as most people made their own goods, or purchased them from locally owned shops who would make their own products. Before this time, the United States government had no formal oversight of these products and left issues of quality and purity to the individual manufactures, or at times, individual states. However, as more people moved into cities to work in factories and other urban jobs, pre-made goods were needed as city dwellers could not produce these themselves.

At the turn of the 20th century, there were no federal regulations to protect the public from dangerous drugs. “It was a menacing marketplace filled with products such as William Radam’s Microbe Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer,” says John Swann, Ph.D., a historian at the Food and Drug Administration in Rockville, Md. “Products like these were, at minimum, useless remedies that picked the pocket of the user, but they could also be downright harmful.”

Today, the drug review process in the United States is recognized worldwide as the gold standard. Drugs must undergo a rigorous evaluation of safety, quality, and effectiveness before they can be sold.

I think the FDA’s biggest contribution to health has been through its progress in evidence-based medicine,” says Steven Galson, M.D., who has served as director of the FDA’s Center for Drug Evaluation and Research (CDER) since July 2005.

References

Golub, A., Bennett, A. S., & Elliott, L. (2015). Beyond America’s War on Drugs: Developing Public Policy to Navigate the Prevailing Pharmacological Revolution. AIMS public health, 2(1), 142–160. https://doi.org/10.3934/publichealth.2015.1.142

Zhou, C., Fruitman, K., Szwed, S., Wickersham, M., Spellun, J., & Zonana, J. (2022). Weill Cornell Medicine Wellness Qlinic: Adapting the Student-Run Clinic Model to Expand Mental Health Services and Medical Education. Community mental health journal, 58(7), 1244–1251. https://doi.org/10.1007/s10597-022-00943-9