The Governing Agencies of Healthcare Providers, Drugs, and Medical Devices: Do we Need Them?

Whenever a discussion is brought up among peers about the United States healthcare system, opinions may range from us having the best regulatory systems and care, all the way to us having the worst systems in place. How does one rank a healthcare system? Is it lives saved? Is it the amount of dollars spent on research and development? Is it the amount of breakthrough lifesaving drugs that are created? Is it the emergency room waiting times or the number of patients a doctor sees in a year?  Ranking the United States Healthcare system can be based on opinions and love of one’s country, but we’re here to look at the facts. We will investigate how the Healthcare system meshes from the regulatory overlords of education, drugs and medical devices. 

The education and schooling to become a doctor is a very long and expensive process that is regulated by the Association of American Medical Colleges1(p87). Admission to medical school is very selective, less than half of applicants get accepted into programs in the United States1(p87). A substantial amount of funds that help finance medical programs come from the United States Federal Government. With that kind of help, the ratio of full-time staff to students is 1.77:11(p88). Yes, you read that correct, almost two staff members to one medical student. Physician demand is projected to outgrow the supply of physicians graduating by 20321(p98). There are many complexities to becoming a doctor. In order to address the supply and demand curve, the staff to student ratio needs to be addressed. So, I pose the question, why does there need to be such a high ratio of staff when the MD applicant is learning for 8 years? Sick people are not going away anytime soon, so the projected Doctor shortage must be addressed, or we are looking forward to some scary times. 

Doctors are necessary in providing care to their communities but that’s just the tip of the iceberg. From firsthand experience, some doctors say they couldn’t do what they do without the help of the nurses and medical technicians. There are a few different routes to become a nurse by completing a training program followed by a state test, all regulated by The American Association of Colleges of Nursing. Diploma in nursing based in a hospital, an associate degree in nursing (ADN) from a community college, and a bachelor’s in science degree in nursing (BSN) from a four-year college are paths to becoming a nurse1(p99). More hospital systems are pushing towards a BSN degree to work1(p99) but it’s the same state test an ADN must take, so if you ask me, it sounds like an education money grab but that’s neither here nor there. In April 2022, there was a nursing workforce analysis done and more than 100,000 nurses left the workforce during the pandemic years 2020-20212. Yes, I understand the need for quality education for nurses, but with nurses leaving the workforce, why are hospital systems pushing for the longer education process when the same state board test must be taken by a two-year program?  

The United States employs a centralized process through the FDA for pharmaceuticals and medical devices going to market1(p141). This is good because we all know the process and institution these products go through, it’s not some back alley dealing where whoever pays the most gets pushed through. Our centralized process provides an easy path to track medical devices from manufacturing, all the way to the patient that has the device and post market surveillance to monitor side effects. If we didn’t have a centralized process, there is no telling what would be brought to market. I believe it would lead to medical device manufacturers using short cuts and cheaper materials to help their bottom line at the expense of the patients. 

The U.S. Food and Drug Administration is the governing body of how pharmaceuticals are researched, tested and then brought to market1(p126). New drugs go through rigorous testing on animals, then humans and then the post market monitoring system to look for long term side effects. It wasn’t until 1976 that medical devices were brought under the FDA fold, before then there wasn’t a regulatory body governing the go to market research and development of devices1(p137). Medical devices differ in research and development from pharmaceuticals because physicians work hand in hand with companies to develop and advance the devices1(p139). This is good and bad; its good because the manufacturers are hearing first-hand about how the devices work and how they can be improved. The bad part is it can potentially lead to conflicts of interest. An example would be the manufacturer listens to a doctor’s input and not others due to a close friendly working relationship.Governing bodies are a necessary evil. If we didn’t have them, there wouldn’t be a process to ensure quality healthcare providers, medicines and devices. I don’t want to see a world where there aren’t checks and balances for products that help us medically. On the contrary, why aren’t the governing bodies working to address the healthcare providers shortage with more concise training, better staff to student ratios and adding more accredited programs for future providers to learn? I’d love to hear your input in the comments below. 

Sources

  1. Goldsteen RL, Goldsteen K, Goldsteen B. Jonas’ Introduction to the U.S. Health Care System. King of Prussia, PA: Springer Publishing Company; 2021

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