Providers say they likely won't have the resources to adhere to enforcement of decades-old laws mandating the U.S. Food and Drug Administration oversee laboratory-developed tests.
On Tuesday, the House Energy and Commerce Committee's Health Subcommittee held a hearing on legislation that would limit the FDA's ability to regulate the products, an authority it's had since the 1970s. (PDF). Companies like Theranos have been able to market diagnostic tests without this oversight.
The FDA had chosen not to enforce regulatory requirements for laboratory-developed tests, or LDTs, because they were relatively simple tests generally confined to local labs, and often used and tweaked to identify rare conditions or address specific patient needs. But the tests have become more complex, without data proving their success. And the FDA now says some of those tests are problematic. In a report released late Monday night, it highlighted 20 examples, including some used to detect ovarian cancer, whooping cough and human papillomavirus.
“These tests may suggest that a patient doesn't have a disease or condition, when in fact they do,” Dr. Peter Lurie, the FDA's associate commissioner for public health strategy and analysis, said in a blog post that accompanied the report.
Last year, the FDA released draft guidance that would phase in premarket review requirements and regulate the quality system for high-risk LDTs, like those used to diagnose cancers, and moderate-risk LDTs, like those used to test glucose levels. The FDA aims to finalize the document in 2016.
Groups such as the American Cancer Society Cancer Action Network and the American Society of Clinical Oncology support FDA regulation of these tests. Others, however, such as the Association for Molecular Pathology and the American Association for Clinical Chemistry, would like to see the CMS take an active role in overseeing the products.
CMS officials aren't interested.
“The CMS does not have a scientific staff capable of determining whether a test is difficult to successfully carry out or likely to prove detrimental to a patient if carried out improperly,” Dr. Patrick Conway, the agency's chief medical officer, said at Tuesday's hearing. “This expertise resides within the FDA, which assesses clinical validity in the context of premarket reviews and other activities aligned with their regulatory efforts under the Food, Drug and Cosmetic Act.”
The CMS would rather continue its post-market activities, which include focusing on a laboratory's quality standards, protocols and procedures, Conway said.
Providers might be hesitant to work with the FDA simply because they haven't worked with the agency before, Dr. Jeffrey Shuren, who oversees FDA's device unit, said at the hearing.
Some lawmakers were wary of any additional federal oversight as they feel that could stifle innovation or change the way providers now care for patients by potentially taking away tests they rely upon. Shuren said that tests that return inaccurate results could hurt patients by misleading physicians and their treatment route, especially because makers of LDTs don't submit data or proof that their tests are working properly.
“Are we effectively opening the door to the federal regulation of the practice of medicine?” asked Rep. Michael Burgess (R-Texas), who is also a physician.
One of the most recent cases where a company was able to profit from the lack of regulatory oversight is the blood testing startup Theranos, which has made billions for its founder, Elizabeth Holmes. Earlier this year, a Wall Street Journal investigation questioned the methods the company used to conduct its tests. FDA inspection reports later revealed that Theranos had indeed failed to meet certain federal standards.
