NEW YORK (GenomeWeb) – Laboratory directors from more than 20 hospitals, academic health centers, and clinical laboratories are asking the Obama Administration not to allow the US Food and Drug Administration to regulate laboratory-developed tests.
FDA regulation of LDTs has become a hot-button issue for the developers, as well as the FDA and some politicians, in the past few years, and in a letter sent on Wednesday to Brian Deese, the acting director of the Office of Management and Budget, the lab directors laid out several points describing how FDA regulation would put public health at risk.
Their letter follows correspondence from five Senate Democrats a week ago that sought the release of LDT draft guidance from FDA. While the legislators argued that FDA regulation of such tests is necessary to ensure proper safety to the public, especially as new understanding of genomics and genetics has resulted in greater use of LDTs by physicians, the letter sent this week said that LDTs are now vital to the practice of medicine and further regulation could bring negative consequences and hamper innovation.
The letter laid out four concerns. First, the lab directors said that the ability to develop LDTs under the current regulatory framework — whereby the tests are regulated under the Centers for Medicare and Medicaid Services' Clinical Laboratory Improvement Amendments, as well as state laws and accreditation by organizations such as the College of American Pathologists — has "been critical to the growth of personalized medicine" and the ability to keep pace "with the changing face of disease to best serve patients and clinicians."
LDTs are often developed in response to unmet clinical needs and often used for diagnosing diseases for which no FDA-authorized test is available. "Nearly all diagnostic tests and FDA-approved test kits begin as LDTs, and in many cases, LDTs represent the standard of care," the lab directors said.
They also said that the FDA has no authority to regulate the tests because LDTs are laboratory testing services, not devices, under the Food, Drug, and Cosmetics Act. The testing services are not sold into interstate commerce, and the services "are the practice of medicine, not the manufacturing of medical devices, and accordingly, our laboratories are not medical device manufacturers."
The letter also argued that because LDTs are regulated under CLIA rules, labs conducting LDTs are already carefully inspected, test protocols and validation is exhaustively reviewed, and laboratory performance is continually monitored.
Lastly, it said that FDA regulation would result in the stifling of innovation and that some labs would no longer be able to continue offering LDTs. "Some testing currently performed at laboratories as LDTs will never generate the financial returns to justify the costs of obtaining FDA clearance or approval," the lab directors said.
They further said that their institutions often have to tend to patients with a rare disease, for which there are no FDA-approved or –cleared devices. In some instances, the total volume for an LDT for such conditions is fewer than 100 each year. "These patient populations are often far too small to support the commitment of finances and human resources to pursue the FDA regulatory process," the letter said.
However, the Senators noted in their letter last week that the US Centers for Disease Control and Prevention recently reviewed an LDT for Lyme disease and found serious concerns about the test. The agency determined that the diagnosis for the disease should be made using only FDA-approved tests.
The lab directors countered that LDTs "have long addressed emerging public health risks," and cited the instance of HIV, saying an LDT Western blot was developed to help establish a definitive diagnosis of the disease two years before an FDA-approved test became available. Similarly, LDTs have also been developed for other emerging diseases, including SARS and H1N1, as well as for certain cancers. Tests for cancer biomarkers, such as KRAS mutations, for example, were available long before FDA approved or cleared them for marketing.
"It was the validation and demonstrated viability of these vital cancer diagnostics as LDTs which made the subsequent development and commercialization of an FDA-approved or –cleared diagnostic possible," the letter said.