The Food and Drug Administration announced a controversial final rule aimed at improving the safety of laboratory diagnostic tests following years of controversy about the agency’s oversight of the products, including during the COVID-19 pandemic.
“LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s,” FDA Commissioner Robert Califf told reporters on Monday. “The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work.”
LDTs detect a range of diseases and chronic health conditions by collecting human specimens, including saliva, blood, and tissue samples, influencing an estimated 70% of all healthcare decisions.
Although the FDA has historically taken a discretionary approach, exercising oversight in limited circumstances, the agency’s new rule classifies LDTs as medical devices, phasing out the current regulation scheme over the next four years.
The agency says the risks to patients for limited oversight have grown over time as more patients depend on the results of LDTs for major medical decisions and as LDTs increasingly rely upon complex medical technology and software.
The FDA’s former policy on LDTs came under fire during the COVID-19 pandemic when the agency significantly delayed private labs from producing rapid tests for the virus in early 2020.
The agency has also been accused of slowing the development of over-the-counter COVID-19 rapid tests, the first of which was not authorized until December 2020, nearly one year after the identification of the virus by clinical researchers.
Senate Health, Education, Labor, and Pensions Committee ranking member Bill Cassidy (R-LA) has been a staunch opponent of the agency’s rule since it was proposed last year, in part because of the agency’s chilling effect on critical testing technology during the pandemic.
“This rule will undermine access to essential laboratory tests, increase healthcare costs, and ultimately harm patients,” said Cassidy, a gastroenterologist. “During the pandemic, we saw how too much government interference and red tape delays lifesaving care to Americans.”
The agency’s risk-averse approach to LDTs during the pandemic stemmed in part from the controversy over the fraudulent medical testing scheme propagated by Elizabeth Holmes, the CEO of the testing company Theranos. With the company’s peak in 2015, Theranos defrauded hundreds of thousands of patients by promising cheap, rapid blood tests, a significant portion of which offered patients false results.
The FDA stepped into the conflict to prevent Theranos from producing potentially inaccurate Ebola and Zika tests during their respective outbreaks in the 2010s.
Holmes was sentenced to 11 years and three months in prison in November 2022 for fraud.
The agency is also establishing a system by which patients and physicians can report flaws or adverse events following LDTs.
Jeff Shuren, the director of FDA’s Center for Devices, told reporters that the agency has included flexibility in its rules to account for the rapid development testing capacity during a public health emergency.
“Greater oversight of LDTs will put patients and healthcare providers in a better position to understand and have confidence in their tests,” Shuren said.
“The agency’s economic analysis estimates the benefits of the phaseout policy outweigh the costs,” he said. “These benefits include an anticipated reduction in healthcare costs associated with unsafe, ineffective tests, including tests promoted with false or misleading claims, and some therapeutic decisions based on the results.”
A spokesperson for the FDA also assured reporters that stakeholders in the medical device and testing industry have been consulted in this decision and support the rule.
Critics of the rule, however, assert that the FDA’s action oversteps the agency’s statutory bounds and will likely have a negative effect on innovation in the industry.
“The FDA does not have the authority to unilaterally increase its regulatory jurisdiction,” Cassidy said. “Congress needs to take action to clarify the regulatory structure for diagnostic tests.”
When asked about the potential clash between the FDA’s regulatory authority and congressional legislative efforts on the regulation of LDTs, Shuren denied that the rule exceeded the agency’s powers, but he said that it would be willing to work with Congress in the future.