The U.S. Food and Drug Administration (FDA) submitted a proposal Friday to begin regulating clinical laboratory testing, a multibillion-dollar business that it says leaves patients exposed to growing potential Risk of wrong results.
The proposed rule would end decades of regulatory ambiguity and formally bring thousands of tests performed by large labs under FDA oversight. Commissioner Robert Califf said the change will help ensure tests used to diagnose cancer, heart failure and thousands of other conditions are safe, accurate and reliable.
“An increasing number of labs are creating clinical diagnostic tests with no guarantee of their effectiveness,” Kaliff said in a statement. He added that the agency is concerned that many of the tests offered by labs are not as accurate or reliable as those reviewed by the FDA. .
What follows is the history and background of the analytical issues.
What is a clinical laboratory test?
Most people are familiar with clinical tests, such as those used to diagnose COVID-19, strep throat, and other health conditions. The tests are performed by a handful of large laboratories and are subject to FDA oversight before being sold to hospitals, doctors’ offices or pharmacies.
The tests targeted by the FDA’s recent actions are created and used by high-tech labs, such as those applied by academic medical centers and companies like Quest Diagnostics. They include tests to diagnose complex diseases like cancer or simple conditions like high cholesterol and sexually transmitted infections.
The FDA said Friday that in the 1970s and 1980s, most lab tests were “low-risk, low-volume” products used primarily on local patients.
Over time, the analysis performed by the lab has become a multimillion-dollar business, processing thousands of blood, urine and other fluid or tissue samples sent in every week from hospitals and clinics. Others target ads directly at consumers; some even aim to measure the risk of Alzheimer’s disease or autism.
Although the FDA has consistently said it has the authority to intervene, laboratory testing has eluded FDA oversight. Debate over regulation of the industry dates back to the 1990s, with some government advisory groups recommending that the FDA tighten regulations.
Why does the FDA need to regulate now?
Many laboratory tests are core elements of health care and are used to make important decisions about pregnancy, nutrition, or many other health issues.
FDA officials have long expressed concerns about the accuracy of some tests, with patients known to have received false results for heart failure, Lyme disease, cancer and other conditions. Incorrect results can lead to incorrect diagnosis, lack of treatment, or the prescribing of unnecessary medications or procedures.
The agency established stricter standards for the industry more than a decade ago, but they were never made concrete.
The tests have drawn increased scrutiny after Theranos founder and CEO Elizabeth Holmes was sentenced to prison last year for misleading investors about the possibilities of her company’s blood tests.
During the pandemic, the FDA warned that dozens of COVID-19 tests that U.S. labs rushed to market without oversight were inaccurate.
More recently, surveillance has begun with pregnancy tests designed to detect mutations that can cause Down syndrome, cystic fibrosis, and genetic defects. Several studies have found that some tests can misdiagnose or exaggerate the risk of these diseases.
What do analysts think about manufacturers?
The labs maintain that FDA regulation will stifle their ability to innovate and quickly develop new tests. They also claim the new rules are unnecessary because they would duplicate existing ones.
Under a provision of federal law, clinical testing laboratories are regulated by the same agency that administers Medicare and Medicaid, the government health insurance for seniors, disabled or poor people. Inspectors evaluate laboratory conditions and procedures but not specific analyzes or the advertising of them in the marketplace.
Last year, lawmakers drafted a bill backed by FDA officials that would authorize the agency to regulate high-risk testing. But the industry’s lobbyists managed to defeat it in the House of Representatives.
What does the FDA recommend?
Under the new proposal, the FDA would phase in stricter laboratory regulatory standards over five years. Some tests already on the market will be exempted, but the FDA wants to hear from the public. At the end of this process, most new analyzes will comply with FDA standards and regulations.
The agency said the new rules will reduce health care costs caused by “unsafe or ineffective tests, including those promoted through false or misleading advertising.”
The agency will seek public comment on its proposal within 60 days before developing a final draft. There is no deadline for this process and it usually takes months or years.
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