In 1862 President Lincoln passed legislation to create the Bureau of Chemistry as part of the Department of USDA. It was the creation of the first governing agency that would regulate the medical field. It would eventually become the Food and Drug Administration (FDA). Since then multiple presidents and congresses have gradually passed legislation to increase the power and authority of the FDA in regulating all aspects of the medical field. It is safe to say, that the medical industry is one of the most regulated, and with good cause. Medicine affects all of us. Whether it is the administration of an epidural during child birth, vaccinations during childhood, receiving an x-ray and setting a broken bone during adolescence, standard checkups during adulthood, MRI scan in our 50’s, a knee replacement in our 70’s, and even admittance into a nursing facility late in life. Additionally, all over the counter and prescription medications, needles, bandages, bedpans, wheel chairs, surgical bed drapes, surgical equipment, endoscopes, MRI machines, etc. are highly scrutinized and meticulously regulated for safety and efficacy. Is the system perfect? No. Does the system help us? Yes and no.
The medical industry is unique when compared to other thriving business industries. The medical field provides life-sustaining, life-saving, and life-improving products and services. The companies that develop, manufacture and sell these products do so in order to capitalize on a market opportunity. When the opportunity is no longer feasible or better said, “not worth the company’s time and money” the company will no longer pursue that product or service. It is simply economics. Within this industry it is common to spend upwards of $1-$5 million to bring a simple medical device to the market like a urinary catheter. Whereas, some more sophisticated medical equipment (i.e. MRI machine, artificial heart, dialysis, prosthetic limbs, etc.) will cost $50-$100 million to bring to the market. These costs are low when compared to the costs to bring some pharmaceutical drugs to market. Pharmaceuticals can cost $500 million to $1 billion plus. Now you might say that this is ridiculous. Well that is exactly what many entrepreneurs, business executives, start-up companies, industry experts, hospital administrators and university officials might say. The costs to comply with the designated legislation passed by Washington are in many cases too high.
So you might ask, “What happens to the innovative new device that is going to help people with diabetes no longer be at risk of an insulin overdose, when the company developing the device closes because the 7 – 10 yrs and $5 million price to have this device tested and approved by the FDA is too much?” That is a great question, with various answers. One thing is for sure; the American people with diabetes are the ones who suffer, because a possibly great opportunity to improve their lives never made it to the U.S. market.
My research this year will delve further into the relationship between medical innovation and Washington’s legislation. Are there positive and negative trends? What possible improvements could be made? Does our regulatory system have too much legislation dictating the direction and nuances of an industry that should be focusing on improving lives? To help with my research I will draw from clinical data, published journal articles, information from the FDA, industry and regulatory experts, and additional forms of media where reliable opinions can be gathered.