A move by the US Food and Drug Administration (FDA) to regulate the diagnostic tests developed in thousands of laboratories is picking up steam Fire and drawing. The agency recently informed Congress that it plans to regulate some of these so-called laboratory developed tests (LDT) -which, unlike tests marketed by diagnostic manufacturers currently do not require FDA approval. FDA has not yet issued draft guidelines on the matter, but at a hearing yesterday, members of the House of Representatives Health Subcommittee of the Energy and Commerce Committee has raised questions about the authority of the agency to regulate these tests, motivation to do it, and potential impact of these regulations on the diagnostics industry.
Doctors use diagnostic tests to determine which patients are at risk of developing a disease that could benefit from treatment. And while companies offer FDA-approved kits for many of these uses, clinical laboratories often design and deliver their own. According to the American Clinical Laboratory Association (ACLA), more than 11,000 laboratories are allowed to develop and execute LDT, and the majority of them do.
FDA the power to regulate all LDT and in vitro diagnostics -since 1976, said Jeffrey Shuren, FDA's Center director for Devices and Radiological Health, at the hearing. But the agency has so far exercised "discretionary authority" and did not require the production of these laboratory tests seek approval. Labs were instead regulated by the Centers for Medicare & Medicaid Services through 1988 Clinical Laboratory Improvement Amendments (CLIA).
But LDT are not what they were, Shuren said the subcommittee. They are manufactured in large quantities and are increasingly removed from health care centers and doctors who command them. They are also increasingly complex, relying on sophisticated software to interpret the results. Although CLIA ensures that laboratories perform testing correctly, it does not address the clinical validity of the test itself, how accurately it measures the state of a patient. "We have a responsibility to provide more certainty patients," said Shuren.
This is why the FDA for years to regulate fishing LDT and is currently developing draft guidelines for laboratories to seek his approval. The new requirements would not apply to all tests. Those that the FDA considers "low risk", those who diagnose rare diseases, and those who have no FDA-approved equivalent would continue to enjoy a freedom of execution. But for the rest, laboratories will submit data proving their validity. But he does not yet know how many laboratories would be subject to new requirements.
Some lawmakers and stakeholders balk at the idea of greater involvement of the FDA. Alan Mertz, president of ACLA and a witness at the hearing, argued that the proposed regulations would discourage laboratories to develop new innovative tests and prevent timely resolution of testing new uses. Mertz, and several representatives also challenged the FDA's authority to regulate LDT, arguing that they are "devices", but rather the services provided to a patient, and are already regulated under CLIA effectively.
But others welcome the initiative of the FDA to raise the regulatory bar. Christopher Newton-Cheh, a cardiologist at Massachusetts General Hospital in Boston who testified on behalf of the American Heart Association, called the current system "completely opaque." Doctors are often unaware if the test they order is FDA approved, and inaccurate results increase the risk that patients will undergo unnecessary treatment or be excluded from treatment based on misinformation. "This is the right thing to do for patients" he said.
FDA may waive its draft guidelines on or after September 29. once the agency finalizes the direction it intends to phase in the new process review over 9 years.
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