(Newswire.net — December 20, 2017) — Over the past two-and-a-half decades, there has been a great deal of controversy surrounding laboratory developed tests (LDTs), which the Food and Drug Administration felt they had the power to oversee. The debate over exactly which branch of government had authority over LDTs and what acceptable best practices would be has sparked from time to time. Unfortunately, until quite recently, a great number of LDTs have produced results, also controversial at times, which led to misdiagnoses that had serious consequences for the person being tested.
Who Oversees the Labs?
Before even looking at some recent developments, it is important to understand exactly who is responsible for overseeing the labs to ensure a scientific approach to any and all tests being conducted. As part of training within online medical lab science programs, for example, you are taught which governing bodies labs answer to, and when a drug or other product is developed, who gives the green light to launch that particular product? If you find the following controversy interesting, a career as a medical scientist might interest you as well. You can learn about a top-rated NAACLS accredited medical laboratory scientist program here.
Medical Laboratory Scientist Regulations
Of course, as part of the curriculum, you will obviously learn about the FDA and the CMS (Centers for Medicare & Medicaid Services) and why each has a role to play in the development of new tests within the field of medicine. Oddly, the FDA probably overstepped their bounds because the law clearly states that the CMS is responsible for the regulation of all medical lab science testing on humans.
The only thing the CMS can’t regulate is research. Knowing this, the FDA stepped in and claimed responsibility for LDTs because they fall somewhere in the grey area between clinical testing and research. All of this may sound a bit vague, but both agencies have a part to play: one in developmental research and the other in clinical trials on humans.
Why Can’t the Two Bodies Work Together
At the heart of the controversy, the FDA maintains that they are the correct agency to deal with the development of LDTs because that is the research phase of any new product or medication. Unfortunately, one prominent suit was brought against the FDA and a research lab because the scientist in charge found that a test could make an accurate measurement but the suggested treatment didn’t agree with the findings of the test. Complaints were lodged that the laboratory in question and the debate sparked anew.
In any event, few products and medications would be on the market if labs didn’t continue working on laboratory developed tests. The real issue seems to be the fact that there is no actual governing body because the FDA can oversee the labs but has no real authority to regulate them. Medical science is advancing by the day and there is a real need to continue scientific tests if there is any hope of curing previously thought to be incurable diseases. The controversy will obviously continue, but so too will today’s youth continue to seek answers in the field of medical laboratory science. Today’s students are tomorrows scientists and, by then, let’s hope the FDA and CMS have their roles ironed out.
Note: Some states don’t require a license but getting a job as a medical laboratory scientist would be difficult without proper credentials.