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Years ago, the agency developed a draft guidance to increase their control of LDTs, but it has been stalled in the Office of Management and Budget (OMB) since 2010.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device, and biologics industries”), and more recently from five Senators, the FDA said it will finally release its draft guidance—which, according to those who have seen the guidance, would treat LDTs as medical devices, requiring premarket approval in some cases.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!