A powerful subcommittee says a new FDA proposal on medical testing will stifle innovation and may not be legal. Action Alert!
Three months ago we told you about laboratory-developed tests (LDTs)—inexpensive diagnostic tests for patients that are developed and performed by local labs. They include standard tests but also new ones, genetic tests, tests for rare conditions, and even custom diagnostics.
Tests like this are the future of medicine. People will soon be able to test for and spot cancers long before they manifest themselves using current methods. Testing can already help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases.
The new testing technology is a real hot potato for the FDA. Regulators are often suspicious of new products. The agency is also more influenced by older firms offering old technology. After all, it is the older and well-established firms that pay the FDA’s bills. Protecting them can also lead to lucrative jobs after leaving government. This is the old crony capitalist conundrum. It’s so easy for the foxes and those guarding the henhouse to make a deal.
Years ago, the agency developed a draft guidance to increase their control of LDTs, but it has been stalled in the Office of Management and Budget (OMB) since 2010. After pressure last May from the Combination Products Coalition (a lobby for the “drug, device, and biologics industries”), and more recently from five Senators, the FDA said it will finally release its draft guidance—which, according to those who have seen the guidance, would treat LDTs as medical devices, requiring premarket approval in some cases.
This has led others in Congress to accuse the FDA of overstepping its authority, with the House Energy and Commerce Health Subcommittee taking the lead. After our article was published, Rep. Michael C. Burgess (R-TX), the committee’s vice chair, said in a statement that the FDA’s regulatory approach to LDTs in this guidance “is redundant, will stifle innovation, and will require additional taxpayer funding for the FDA.”
On September 9, the subcommittee held a televised hearing on the regulation of LDTs at which the FDA, together with various industry, investor, and patient “stakeholders,” testified. The committee got to the heart of the matter when they grilled Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health: they questioned whether the agency even has the authority to regulate LDTs in the first place.
Shuren claimed the FDA’s authority to regulate LDTs was conferred in 1976 when Congress changed the definition of “medical device” to include all in-vitro diagnostics. Rep. Burgess pointed out, however, that 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:
LDTs are not medical device products sold through interstate commerce. They are services provided only to the ordering healthcare provider and offered only by labs that validate and develop them. Professional medical services are not regulated by FDA….LDTs neither constitute “medical devices” nor are commercially distributed among states—both requirements for FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Rep. Burgess also noted that the FDA is overburdened and takes too long to approve products, which increases uncertainty for companies and negatively affects innovation. “If LDTs were regulated as medical devices by FDA,” he wrote, “it would significantly tax an already overtaxed agency and stifle [patient] access to these important tests.” Burgess might have added that this kind of regulation would also drive up costs to the point where the tests might no longer be feasible for general use.
Shuren stated that the proposed changes to the LDT regulations don’t require the agency to follow the rulemaking process. Rep. Joe Pitts (R-PA), Health Subcommittee chair, pointed out that even if FDA did have the proper authority, the agency should follow the formal rulemaking process that such huge policy changes require, rather than skirting the law by issuing a guidance.
We would remind readers that this issuing of guidances instead of going through the rulemaking process is a common FDA maneuver. We saw them do the same thing previously, when the FDA issued its draft guidance on NDIs (New Dietary Ingredients, i.e., nutritional supplements).
Shuren claimed in his hearing testimony that the FDA will continue to use its enforcement discretion and will only regulate tests that carry the highest risk, but in his written testimony he said, “FDA intends to continue to exercise enforcement discretion for many LDTs—including those that are low risk, for rare diseases, and for unmet medical needs.” So which is it—“high risk” only or “low risk” too—and how can we ever know what “enforcement discretion” will mean in the future?
Those words—“enforcement discretion”—are dangerous. They can mean carte blanche for an out-of-control agency to be as ruthless as it pleases, as it has many times in the past with little rhyme or reason. The lack of any formal rulemaking means the public has no say in the matter.
Remember our report on Theranos, the exciting new blood testing company with very high-profile investors? Its technology will allow you to walk into your Walgreens, with or without a prescription, and get blood test results the same day with astounding accuracy rates and at very low cost. We would like it even better if you could choose to take their tests at home and mail them in, but that could be in the future.
Theranos is not a fly-by-night organization. Recognizing how politicized and predatory the medical field has become, it has assembled the single most influential board in US corporate history. It includes former Secretary of State, Treasury, and Labor George Shultz; former Secretary of Defense Bill Perry; former Secretary of State and National Security Advisor Henry Kissinger; and former Senators Sam Nunn and Bill Frist (who is also a heart transplant surgeon), among others. Just imagine what all those heavy-hitters have to be paid for the protection they provide. It is presumably worth it, because this blue-chip board may be the only reason that Theranos has gotten as far as it has.
Theranos is a prime example of innovation in the LDT field, in which startups are creating much cheaper and more accurate tests. On the one hand, Theranos is direct competition for the big, established labs such as Quest and LabCorp, though these labs buy their analyzers from third-party medical device manufacturers and therefore do not fall under the current LDT regulatory exemption. Even so, the trade group for traditional diagnostic labs, the American Clinical Laboratory Association, adamantly opposes any effort by the FDA to start requiring approval of LDTs. They also take the position that the FDA lacks the legal authority to do so.
LDTs are not only the future of general medicine—they are also the future of individualized medicine, which is an exciting and important development in its own right. But if the FDA succeeds in broadening its regulatory authority over LDTs, innovation by companies like Theranos are sure to be crushed, medicine will be held back, and medical costs will rise.
The FDA has submitted its draft guidance to Congress, and is expected to release it for public comment soon—unless we act now. Unless significant changes are made before the guidance is opened for public comment, the chances are good that the FDA’s draft guidance will have a profoundly negative impact on Theranos and other innovative labs.
Action Alert! Write to the FDA, and we’ll send a copy of your letter to your legislators. Ask them to clarify their regulatory authority to regulate LDTs, and remind them that even if they do have the authority to proceed, they should follow a formal rulemaking procedure so the public can have a voice in the matter, instead of skirting the law by issuing a guidance. Send your message to the FDA and Congress now!
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Please provide clarification of your regulatory authority to regulate laboratory developed tests (LDTs). Even if you have the authority to proceed, you should follow a formal rulemaking procedure so the public can have a voice in the matter. Such diagnostic tests have huge potential to improve medical care and keep costs down. If you treat LDTs as medical devices, pre-market approvals would result in increased costs and limit innovation.
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The FDA should keep its hands off of LDT’s. It should also leave alone non-pharmaceutical nutritional supplements. If the FDA wants to make consumer access to something more difficult, try stiffening the regulations on Big Pharma and Monsanto. While you’re at it, totally ban all GMO’s from the US food chain.
For far too long, this country has been staggering and dying under bureaucratic regulations developed by agencies which have pronounced themselves “guardians” of the people, while in reality they are feathering their own nests. New inventions, new discoveries, things that could benefit the people have been opposed, restricted, deemed harmful. It is time to permit new technologies, new testing, new and revolutionary discoveries that can benefit the people to be permitted. The FDA has protected itself behind the words “enforcement discretion,” which simply put is the reality that if it doesn’t benefit the FDA or its partners, it will probably not be permitted. LDTs are not medical devices, they are lab tests. They are also the future of medicine. Please do not hold back yet another thing which can help the people. This is no longer 1900. People are educated these days and information can be gleaned from a number of sources so to hold back something that is good for the people will no longer go unnoticed by the populace.
The FDA has long ago lost its usefulness.
They are just a s corrupt as congress, if not even more so.
Why are they allowed to go on with their greedy shams?
LTDs are a nescessity and are part of the future of medicine…Please Do Not obstruct [overcontrol]its purposemmmmmmmmmThanx and Best Wishes to yo folks…..
I have never been much for corporations run amok. Which seems to be the underlying thinking of today. Take software for instance. They’ve never been liable for any damages they’ve caused and yet some of the damage has been real severe as in identity theft and just simple stealing of personal information just to purchase against someone else’s credit card.
Had the software developers been held liable we’d have much safer networks and computers. They have no driving force to even correct the problems in fact it’s going to be the e-tailers that have the impetus to find a solution or risk losing customers. The question now becomes at what point does the internet become a library as people fear losing their money and personal information?
I am writing out of great concern that the already slow overburdend FDA already has too much control over things that are really not their priority. They have failed the American people many times by taking outrageous amounts of time to approve medicines already approved in other countries that with time have proven to be productive, I feel this is just another power play by them & I agree that this will be a waste of time, money, innovation & progress. Congress needs to take the bull by the horns & stop the proposed takeover of this area. Sincerely Janie Anderson
Once again, the FDA earns the appellation Federal Death Agency.
Early diagnosis is vitally important for for many diseases, particularly cancer.
This FDA ukase will be good business for Hong Kong, Singapore, and Mumbai (India); how can the Feds stop Americans from sending their spit samples overseas?
Lets try a new paradigm: voluntary test certification by Underwriters’ Laboratories rather than approval or else by governments. The average American home contains literally hundreds of electrical items potentially capable of burning the place down or electrocuting the occupants. Insurance companies really really don’t like that sort of thing happening – and UL is one of the reasons that such incidents are so rare.
I’m sure that health insurance companies would much rather pay for curing Stage One cancer than paying for often expensive and ineffective treatment of late diagnosed Stage Four cancer. More on UL here:
https://en.wikipedia.org/wiki/UL_%28safety_organization%29
Incidentally, UL is older than the FDA, as well as baing a lot less expensive, faster, and more effective.
The FDA is too corrupt—look at the GMO mess, for example, they approved the GMOs that are responsible for all this Cancer that is plaguing us. And all the members of the FDA that are former members of Monsanto Corp. and vice versa. When all the USA’s food supply is poisoned then what WILL WE DO ????
And the FDA breing in bed with Big PHARMA—is sickening –both literally and figuritivlly. Sorry for my misspelling.
Please reign in this institution—they are supposed to protect us and they are too busy feathering their pockets to do a good job !!!!!!!!!!!!!!!!!!!!!!!!!!
I can already see that this drug will be on one of those future commercials that say, “Did you take ___? If you did, you may have money coming your way as a lawsuit is in effect for this drug/diet formula that was/is harmful to your health. Hassle free, just call this 1-800 # now for the easy process of getting paid for this now banned product. A blah blah amount of money is set aside in the amount of 5 million dollars to help pay for and compensate those unlucky enough to have taken this drug/dietary supplment. Call now and get paid.”
Yeah. That’s what’s going to happen if you market this ILLEGAL dietary drug. Might as well quit your jobs and look elsewhere for employment. Because you aren’t going to even be able to get a job once this is on your resume.
The FDA no longer protects the American people, but has become a tool for corporations that blocks innovation and progress in the medical field. The decisions it makes benifits and protects profits, not people’s health. It needs to be disbanded, and replaced with a new FDA that does what it’s supposed to do. The American people are fed up with this corruption.
FDA lets get the show on the road, we cannot hold up development of devices that may be useful for public health either approve it or disapprove it the ball is in your court make it happen soon. I know U will do the correct thing. Hunter
This attempt to shut down Laboratory Developed Tests (by absurdly redefining them as “medical devices”) strikes me as very similar to their ceaseless attempts to put electronic cigarette companies out of business by categorizing vaping devices as smoking cessation devices (which they categorically ARE, since there is no combustion involved) or some sort of anti-cancer remedy (which they certainly ARE, since there are no carcinogens involved). Everyone knows smoking causes lung disease, and everyone knows lung disease is Big Business, whether it’s overpriced nicotine patches, nicotine gum, Chantrix, invasive surgery, hospital care, or chemotherapy. So along comes a solution which has worked for millions of former smokers, and the FDA steps in claiming by every possible means that it alone has the authority to say whether the public has the right to choose between clearly failed (or outright dangerous or fatal) approved alternatives, or continuing to smoke. But that we are NOT allowed to use our own judgment as to whether to quit inhaling burning carcinogens through the use of commonly available (FDA GRAS: generally regarded as safe) ingredients via a simple battery, a small plastic tube, and a heating coil. Why is this? Because lung disease treatment and smoking cessation drugs (or approved Big Pharma quitting solutions such as expensive patches and gum)…well these are, again, Big Business–and that’s who pays the FDA. NOT small enterprises like purveyors of nutritional supplements, organic foods, and electronic cigarettes.
After taking chemistry classes in college 30 years ago, we learned that hydrogenated oils might be the glue that is causing animal fats to stick to arteries. And, that sodium nitrates, found in processed meats, caused cancer. Why has the FDA never warned the public, or attempted to ban these items? We need professional researchers in charge of the FDA.