FDA Thumbs Its Nose at Congress—Again!

Laboratory Glassware The agency has issued a new guidance on laboratory developed tests (LDTs), even though a congressional committee challenged its legal authority to do. Action Alert!

Last month we told you how the powerful House Energy and Commerce Health Subcommittee took the FDA to task, saying that the agency’s proposal to put laboratory-developed tests in the same regulatory category as medical devices would put a stranglehold on innovation—and may not even be legal. LDTs are inexpensive diagnostic tests for patients that are developed and performed by local labs, and are the future of medicine, as the American Clinical Laboratory Association explains in great detail in its Citizen Petition to the FDA on LDTs.
On September 30, the FDA issued two draft guidance documents on LDTs. These documents confirm that the FDA does indeed plan to regulate LDTs as medical devices.
Even if it turns out that the FDA does have the requisite legal authority (and the subcommittee cast serious doubt on the matter),  guidance is completely unnecessary anyway.  LDTs are already regulated under the Clinical Laboratory Improvement Amendments (CLIA), which is overseen by Centers for Medicare and Medicaid,  and does not require further FDA oversight. As the subcommittee  stressed, the FDA’s proposal would virtually halt creativity and exploration in the rapidly growing field of individualized medical care.
The new guidance requires pre-market approval for many LDTs. This guidance has been stalled in the Office of Management and Budget (OMB) since 2010, but its publication comes after lobbying last May from the drug, device, and biologics industries, and more recently pressure from five senators.
Ask yourself: who benefits most from having the labs come begging the government to approve a new blood test before it’s placed on the market? Could it be the drug, device, and biologics industry—the heavy-hitters who are LDTs’ chief competition? Remember, there was no public health or safety incident that spurred the release of this guidance after so many years of sitting on the shelf—just good old fashioned cronyism, with industry making the government dance to its tune and help them secure the lion’s share of the market.
As we and other health advocates have stressed, such big regulatory changes require a formal rulemaking process. Of course, this is the very thing the FDA wants to avoid! Look at the benefits they get from not going through a rulemaking:

  • They don’t have to solicit or listen to feedback and comments from citizens and stakeholders.
  • They don’t have to perform an economic impact analysis.
  • They get to skirt questions about the FDA’s statutory authority, their lack of informal outreach to lawmakers, and the lack of funding to pay for the agency’s increased regulation costs.
  • They don’t have to explain their demonstrably incorrect belief that there are flawed LDTs on the market.

One of the immediate problems is that the FDA has significantly underestimated the number of labs negatively affected by the draft guidance. They estimated that 650 manufacturers would need to provide notifications for about seventeen LDTs each, but other estimates show that about 2,000 labs will feel the impact.
The first of the two guidance documents provides a framework for oversight of LDTs. It groups them into classes based on risk—the same framework used to classify medical devices. The classification guidelines are so broad that it will create tremendous uncertainty.  Classes II and II (“moderate” and “high risk”) LDTs would require regulation, listing, and adverse event reporting, with a pre-market review to be phased in over several years.
There will be “enforcement discretion” for some LDTs—the FDA will determine on a case-by-case basis whether a pre-market review will be necessary for four groups:

  • low-risk (Class I) LDTs,
  • LDTs for rare diseases,
  • “traditional” LDTs (older, grandfathered tests), and
  • LDTs for unmet needs (when no FDA-approved or equivalent device is available).

But as we told you last month, “enforcement discretion” is an intentionally vague and dangerous term, since it offers no certainty that the manufacturer is fulfilling the guidance requirements or not—and that’s a recipe for FDA abuse, as we’ve seen from the agency time and time again.
Even worse, if a laboratory makes a “significant change” to the already-marketed, originally intended use of an LDT, the test will be considered a new LDT for the purposes of notification and pre-approval. This will absolutely throttle innovation: anything new or improved will automatically be placed in this expensive and burdensome new regulatory system.
The second guidance talks about the notification process that will allow the FDA to classify LDTs by risk-level. The FDA will require basic information about the laboratory, the volume of the test and intended use, any other clinical uses, any disease condition it might test for, the population that would need this test, etc. A full list of the data that will be required for each LDT from each laboratory can be found in Appendix A.
Action Alert! The comment period on these two guidance documents is now open, but with the elections coming up, it’s important that this not get lost in the shuffle—something the FDA is very much hoping will happen. Please tell the FDA how important LDTs are, and tell them to reject these guidances and instead go through a formal rulemaking process. Don’t let the FDA avoid its responsibilities to the American public. Don’t let them keep the voices of grassroots advocates like you from being heard. Send your message today!



  1. There is no justification or reason for the FDA to require laboratories to seek their approval for blood tests. I needed a heavy metals test be done and was glad there was a lab to do it.

  2. Stop and reverse the rise of fascism in America! Stop and reverse the rise of the American fascist capitalist military/police state!

  3. they are supposed to be “protecting” the public………..what happened to that? oh, they are protecting their former employers and current

  4. Here is why it is actually totally unlawful for the FDA to even play in this sandbox:
    It amounts to Prerogative Power – the kind the colonies freed theirselves from. These Kingly powers – expressly forbidden by our Constitution consist of Extra-legal powers, which are factual laws not by law or statute. Supra-legal laws are similar but expect judges and the victims to obey them OVER the legal statutes. The third leg of these prerogative powers is the consolidation of power. The agency takes on the authority our constitution grants ONLY to Congress – quote “All legislative Powers herein granted shall be vested in a Congress of the United States.”
    By making these illegal laws, or unlawful if you choose to be technical, the agencies – given NO legislative (law making) authority whatsoever, in fact DENIED the right to make laws – become the executive, judicial, and congressional branches theirselves. This is also the means by which the people have their right to a jury trial denied and all our judicial processes destroyed. No wonder our country does not have justice.
    Supra-legal Powers –

  5. Is this anything new? The FDA is clearly looking to diversify their means of obtaining approval funding (as drug development has more or less plateaued). This clearly shows what can happen when lawyers, instead of top scientists, are running key government agencies. The corporatocracy at its finest??

  6. I don’t know what ha happened to America but it is not good. Our Congress doesn’t work. They don’t even go to work. To keep your job I thought you at least had to show up. Well Congress has created a Monster with the big Corporations that are out for blood. The blood of the American people. These takers all ready make American’s work harder and more days then any other civilized Country in the world. Now I don’t mind working but I do mind being cheated and lied too. SCOTUS opened the door for a corporate take over of America. Boy are the Corporations doing their damnest to finish their take over of the U.S. and the rest of the world. I am glad Germany can see the future. America is being left in the dust. FDA since GW Bush has gone insane. They are approving so many deadly drugs it is frightening. All doctors say is all drugs have side affects. Well this isn’t good enough. I am demanding American people get the best care for no cost. We should be doing some things right mow that don’t involve greed. FDA doesn’t even care that Monsanto is killing us with their great poison. Killing Bee’s, birds and butterflies . You know there was a little girl who did a experiment on GMO grown sweet potato and a organic one. The Organic one grew like a champ. put out vines and flowers needed for bees to feed. The GMO’S don’t put out any vines. Goes to show they don’t give a damn about saving our bees and birds and butterflies. FDA better cool it’s jets as USDA needs to as well. Both of those agencies have sold out to the Corporations. Congress get a back bone and do your damn job. Everyone VOTE we must get rid of these people who have no respect for us or life. People wake up. VOTE for life.

  7. I’m not sure I understand why one would want to pay double or triple in the retail market what they would pay for a routine lab test from their doctor which would seem to be a better indicator of any disease as they are rechecked for accuracy.

  8. Regulations governing the payment for clinical tests require that each clinical test is directly connected to symptoms or disease. This requirement, which is called Clinical Utility, has an emphasis on measuring the symptom modification in patients.
    Laboratory developed tests, which can claim to support the prevention efforts of the 70%, are being promoted without proven clinical utility and most are adversely effected by a persons biochemical individuality.
    There has been a massive expansion of DNA testing that claims to be individualized to each client. For statistical reasons they lump people into similar groups (1,000,000 or more), to validate a test.
    Many DNA tests are promoted as LDTs. Use of DNA data for prediction does not equal diagnosis. Because there are frequently so many other genetic and environmental factors that can determine whether a disease actually emerges, the risk may never become reality.
    Many direct marketed DNA testing provides prediction information through statistical possibilities, but it claims to provide information on your future risk of disease. Theoretically, with knowledge gained from the DNA test, you will be able to intervene and prevent the development of future disease. This is an unproven theory. Few diseases that develop after childhood have a strong genetic component. Baylor University Medical Center stated that: “Less than 5% of cancers arise from broken or damaged genes. The vast majority is due to epigenetic influences.” Epigenetic influence is the modification of proteins in response to the external and internal environment of the cell
    If not the FDA, can the FTC not do a better job of providing accurate and truthful information to the public.

  9. Does the FDA, or any other part of the current federal government really care at all for the citizens of this country? It seems like it’s all about money. Everybody in government and industry seems to be getting rich while the rest of us struggle along.

  10. I worked in hospital laboratories for over 40 years. I know the type of testing that labs have to go through to establish new tests that are introduced. The LDTs are unreasonable and classifications are ridiculous. These attempted rulings are being introduced by people who don’t do the testing and don’t understand what that testing entails.

  11. When did the FDA become the fourth – and most powerful – branch of the Federal Government???

  12. Our government is NOT supporting the citizens of this country – only the big pharmaceutical companies an. We need to not re-elect any of the current people. Those of us with genetic diseases need doctors and insurance companies that really want the help cure and treat these problems not just symptoms so the drug companies can keep getting richer and we can not afford to get well

  13. Please don’t let this happen. I have terrible allergies and want to get a Celiac test through a local lab instead of having the my doctor do ALL of the test, which will cost around two thousand dollars vs. eighty dollars through the laboratory. My insurance doesn’t cover the full cost. THIS IS NOT FAIR!!

  14. Rescind the new policy to regulate laboratory developed tests (LDTs). uch a regulation will be counterproductive. LDTs are already regulated under the Clinical Laboratory Improvement Amendments (CLIA), which is overseen by Centers for Medicare and Medicaid, and does not require further FDA oversight.

  15. I oppose LDT’s being categorized as medical devices. This action would severely limit innovation and would turn a simple, non-expensive procedure into an unattainable diagnostic test for the very citizens who pay your check

  16. It’s not difficult to understand why the FDA is prohibiting LDTs. The FDA is owned by the large drug and medical device companies. Since LDTs are not from these companies, and compete with them, they are banned to protect the large company’s profits.

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