For years the agency has been attempting a power grab, but it’s just been told to stop. Action Alert! For some time, we’ve been telling you about the FDA’s attempt to impose pre-market approval requirements on laboratory developed tests (LDTs). The agency’s efforts were, thankfully, just dealt a major blow: the Health and Human Services
For years the agency has been attempting a power grab, but it’s just been told to stop. Action Alert!
For some time, we’ve been telling you about the FDA’s attempt to impose pre-market approval requirements on laboratory developed tests (LDTs). The agency’s efforts were, thankfully, just dealt a major blow: the Health and Human Services Department (HHS) announced that the FDA will no longer be regulating LDTs. This is a major victory that will open the door to innovation in a sector of medicine that is incredibly important.
Specifically, HHS states: “FDA will not require premarket review of laboratory developed tests (“LDT”) absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances.” Part of the reason for this may be that LDTs are already regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA). CLIA requires laboratories to hire scientifically qualified personnel and to follow rigorous testing, analytical validation and record-keeping procedures.
These changes could allow a wave of innovation in this industry. The FDA claimed authority over LDTs after Congress amended the Food, Drug, and Cosmetic Act in 1976. But since that time, the agency has only singled out a handful of LDTs for active enforcement. This threat of regulation tends to have a chilling effect on innovation, since labs developing new tests didn’t know whether the FDA would target them or not. With this announcement, hopefully that situation will change.
The FDA’s power grab on LDTs undoubtedly cost lives in the COVID-19 pandemic. It was the FDA’s choice to regulate LDTs for the diagnosis of COVID-19. Labs needed to wait for the agency to grant Emergency Use Authorizations to run their tests, costing valuable time at the outset of the pandemic and delaying the deployment of widespread testing for the coronavirus.
How the feds treat LDTs is enormously important. Medical testing is the future of medicine. New tests already exist to spot cancers long before they manifest themselves otherwise. But these tests are very expensive, and neither Medicare nor insurance companies will pay for them. If they become more widely available, the price will fall. Testing can also help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases.
LDTs are not only important for general medicine; they’re the future of individualized medicine. Integrative doctors use these tests to gather information that aids them in identifying the root causes of their patients’ illnesses—information that cannot be gathered and analyzed otherwise. If the FDA moved forward with its proposal, these developments would have been halted and medicine would be set back years.
There are many more reforms that must be enacted to improve medicine in this country. If you haven’t already, please sign our petition to reform a health system that blocks access to natural treatments that generally cannot go through FDA approval.
Action Alert! Sign our petition that seeks to reform a healthcare system that blocks access to natural treatments that generally cannot go through FDA approval. Please send your message immediately.