Tell the FDA They Have No Legal Authority to Regulate Medical Tests!

An essential tool of natural health is medical testing. But the FDA recently issued a report detailing twenty case studies of supposedly inaccurate or misleading tests—an attempt to bring such medical tests under its authority. If the FDA takes over testing and only approves the tests that the big testing labs can do (and that the insurance companies or Medicare will pay for), there is no future for integrative medicine and little future for medicine as a whole.

What the FDA is doing is not legal—the agency lacks the authority to regulate laboratory-developed tests (LDTs). This responsibility belongs to the Centers for Medicare and Medicaid Services (CMS) alone. Write to the FDA and tell them to stop violating the law and stop harassing innovators in the LDT field.

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Please stop preventing innovation in the lab testing field

Dear [Decision Maker],

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New and innovative medical tests are a vital component of modern medicine, but the Food and Drug Administration seems to be trying to throttle this important medical tool. In doing so, your agency is overstepping its authority, as Congress has already informed you.

In fact, the House Energy and Commerce Health Subcommittee has suggested that the FDA's regulatory approach to laboratory-developed tests (LDTs) "is redundant, will stifle innovation, and will require additional taxpayer funding for the FDA." The subcommittee questioned whether your agency even has the authority to regulate LDTs in the first place. As Rep. Burgess pointed out, LDTs are already regulated through the Clinical Laboratory Improvement Amendments, which is overseen by Centers for Medicare and Medicaid and does not require further FDA oversight.

Rep. Burgess also noted that LDTs are services provided only to the ordering healthcare provider and offered only by labs that validate and develop them, and professional medical services are not regulated by FDA. LDTs neither constitute "medical devices" nor are commercially distributed among states -- both of which are requirements for FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act.

Rep. Joe Pitts pointed out that even if FDA did have the proper authority, the agency should follow the formal rulemaking process that such a major shift in policy requires, rather than skirting the law by issuing a guidance document. The American public MUST have a voice in policies that will have a profound impact on the quality of their health.

Your agency recently issued a report detailing twenty case studies of supposedly inaccurate or misleading tests. Some of the case studies in the FDA's report include tests for Lyme disease, autism, fibromyalgia, heavy metal chelation, and chronic fatigue syndrome. If the FDA is successful in eliminating these tests from the market, then diagnosing will be more difficult and there will be no mandate for insurance companies to cover these debilitating illnesses.

There are already new tests 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.

Accordingly, I am writing to ask your agency to clarify your regulatory authority to regulate LDTs, and to remind you that even if you do have the authority to proceed, you really ought to follow a formal rulemaking procedure so the public can have a say in the matter, instead of skirting the law by issuing a guidance document. I call upon the FDA to stop trying to strangle the innovative field of LDTs while it's still in its infancy.

Sincerely,
[Your Name]
[Your Address]
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