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Alexander: FDA’s Proposed “Double Regulation” Could Halt More Than 60,000 Lab-developed Tests Americans Depend on for Lifesaving Treatments, Cures

Proposed FDA Guidance Threatens Availability of Tests Performed Under the Precision Medicine Initiative That Help Diagnose, Treat, Cure Disease

WASHINGTON, Sept. 20—Today U.S. Sen. Lamar Alexander (R-Tenn.) said that under the FDA’s proposal to regulate laboratory-developed tests, which Alexander pointed out are already regulated by an arm of the Centers for Medicare and Medicaid Services (CMS), “the biggest loser, it seems to me, would be Americans who stand to benefit from the rapid pace of science and discovery.”

At a hearing of the Senate health committee, which Alexander chairs, he said that this amounts to unnecessary “double regulation” and offered an example of what this added burden could mean for medical innovation and patients who benefit from it.

Vanderbilt University Medical Center performs 105 lab-developed tests, which Alexander said are “medical tests designed, manufactured and used in a single laboratory.” If just one of these 105 tests were subject to FDA approval, it could cost Vanderbilt $30-75 million to go through the process. And the possibility that any or all of the remaining 104 could be subject to the lengthy, costly FDA approval process could make costs prohibitive. “You can quickly see how costs could add up—even into the billions,” Alexander said.

Alexander continued: “The Chair of the Department of Laboratory Medicine at the University of Washington wrote Sen. Murray and me suggesting the proper approach would be to modernize the [current] system to ‘promote continued patient access to affordable, high-quality tests without duplicative regulations.’”

The full text of the chairman’s opening statement, as prepared, follows:

Laboratory-developed tests are medical tests that are designed, manufactured and used in a single laboratory.

These are labs in doctors’ offices, hospitals, universities, state public health departments, private companies -- places where scientists both develop and use tests to determine whether you have a disease or whether a certain drug will work for you.

There are more than 60,000 lab-developed tests available to Americans today to help screen for, and diagnose, diseases and conditions, such as rare or emerging infectious diseases and different types of cancer.

Let me share two examples of lab-developed tests. 

Last year, President Obama announced the Precision Medicine Initiative which will involve mapping 1 million genomes and has the potential to transform medical treatment in this country.

I attended a summit the president convened on the topic in February, when he recommended expanding access to a breast and ovarian cancer test developed by a commercial lab called Color Genomics.

To take this test, anyone can ask their doctor to order it, pay about $250, provide a simple saliva sample, send the package back in the mail, and work with your doctor to understand your genetic risk for developing these cancers.

As part of the president’s Precision Medicine Initiative, Color Genomics said it is going to double the number of free tests offered to women.

This test is an example of a lab-developed test—in this case, one developed by scientists in a commercial lab.

Here’s another example:

A woman in her 80s goes to Vanderbilt University Medical Center for care. At Vanderbilt, someone puts a needle in her vein, takes blood and sends it to Vanderbilt’s lab.

Four days later, her doctor gets the results back from the lab and finds out that a certain blood thinner won’t work for his patient—the patient would respond poorly to it. He prescribes something else.

Using that one blood test, scientists at Vanderbilt can find out whether the patient has one of 184 changes within 34 genes that might affect the way their body absorbs, distributes, metabolizes or excretes a drug.

Through its award-winning PREDICT program, Vanderbilt has been able to put important drug interaction information into patients’ medical records so that doctors can know how they’ll respond to medication.

The blood test they use for this is a lab-developed test, in this case developed in the lab of an academic medical center.

Both of these examples involve the president’s Precision Medicine Initiative.

Last month, I visited Vanderbilt, which is receiving a $71.6 million, five-year grant to store and help make useful all the data in the Precision Medicine Initiative.

Dr. Zutter at Vanderbilt estimated that 95 percent of tests used in precision medicine are lab developed tests.

I received an up-close lesson on these tests on a tour of Vanderbilt University’s laboratory.

Vanderbilt’s lab is a good place to learn – the doctors in Vanderbilt’s lab run about 4 million individual tests annually.

Of those 4 million tests, 80,000 are run using tests developed by the doctors in Vanderbilt’s own lab. Vanderbilt has developed 105 of its own tests.

The rest of the 4 million are done using FDA-approved diagnostic kits that are developed by manufacturers and sold to laboratories in hospitals and doctors’ offices where they are performed

We’re holding this hearing today to learn more about lab developed tests and their importance to the advancement of medicine. We also want to discuss a draft guidance released in 2014 by the Food and Drug Administration that would require each of these 60,000 lab-developed tests to be individually approved by the FDA.

The FDA’s draft guidance would change the way lab-developed tests are currently regulated.

Currently, laboratory developed tests are regulated by a program at the Centers for Medicare and Medicaid Services called the Clinical Laboratory Improvement Amendments, or CLIA. CLIA was formed by Congress in 1988.

Sen. Mikulski introduced the “Medical Testing Improvement Act of 1988” in June of that year. It was a bipartisan effort that developed into the Clinical Laboratory Improvement Amendments of 1988 which became law on October 31, 1988. I want to recognize Sen. Mikulski for her leadership and expertise as we look at lab tests to see if modernization is necessary.

In its draft guidance, FDA is proposing that all of these lab developed tests that are currently under the CLIA program be submitted to FDA for approval before they can be used.

This would appear to be double regulation.

Tests would need to meet the CLIA regulations, but then each would require FDA approval.

So what would FDA approval mean for Americans relying on the more than 60,000 different lab-developed tests available in the country today?

First, patients may lose access to tests until they are approved by FDA. And we don’t know how many labs would have the resources to put their tests through the approval process. 

For reference, as of 2010, it took about $75 million to bring just one high-risk device to market through the FDA process.

Vanderbilt has 105 tests. If just one – the PREDICT test—is high risk, that could cost Vanderbilt $30-75 million. You can quickly see how costs could add up – even into the billions.

Infectious disease doctors said in comments to FDA that they were “very concerned that [lab-developed test] oversight, as currently proposed by the FDA, could impede patient access to existing high quality or state of the art tests and threaten needed innovation in the development of novel tests for constantly changing and emerging infectious diseases.”

The Chair of the Department of Laboratory Medicine at the University of Washington wrote Sen. Murray and me suggesting the proper approach would be to modernize the CLIA system to “promote continued patient access to affordable, high-quality tests without duplicative regulations.”

Under the draft guidance, the biggest loser, it seems to me, would be Americans who stand to benefit from the rapid pace of science and discovery.

The Vice President is leading the Cancer Moonshot and proposing to spend $1 billion to help make 10 years of progress in 5 years.

Lab-developed tests have enabled much of the progress already made in cancer research and treatment because they allow physicians to practice at the speed of science rather than the speed of the FDA.

In one example, doctors began testing for mutations in the kRAS gene in 2008-2009 using lab-developed tests. There wasn’t an option approved by the FDA until 2013-2014. 

I am concerned that FDA already has a full plate of responsibilities, and the agency has said it needs more money to meet those responsibilities.

I look forward to hearing today whether additional or different regulation of lab-developed tests is necessary.


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For access to this release and Chairman Alexander’s other statements, click here.