WASHINGTON — After arguing for months that certain medical tests led to patients being mistakenly told they had illnesses and undergoing pointless treatment, the Obama administration Friday dropped its plans to regulate them.
The Food and Drug Administration said a decision on whether and how to regulate the tests would be left to Congress and the new president.
The diagnostics, known as laboratory developed tests, are designed, manufactured, and used within a single laboratory, often in a hospital. They range from simple tests that measure levels of sodium to ones that analyze DNA and help diagnose genetic diseases.
Critics say the lack of regulation is a loophole that allows labs to market unproven tests through physicians and other clinicians that they claim can help patients customize their diets or workout regimens.
In a hearing one year ago, nearly to the day, Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, told a congressional committee that without oversight, LDTs can be high-risk and give the health care providers who rely on them inaccurate information. Some misdiagnosed patients were steered away from treatments that might have helped them, he said.
“Public health concerns raised by these and other examples of defective LDTs require that FDA implement a more proactive oversight policy,” Shuren said at the time. He noted that the FDA would issue its final guidelines by the end of 2016.
But on Friday, FDA spokeswoman Tara Goodin said that while the agency continued to believe that rules are needed to ensure patients and health care providers get reliable tests, the agency’s approach needed more work — and input from the incoming Trump administration and Congress.
“We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right,” Goodin said. “We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.”
The draft proposal was met with opposition from many quarters, among them research hospitals, biotech companies, the American Clinical Laboratory Association, and the Association for Molecular Pathology.
Dr. Roger Klein, professional relations chair for the Association for Molecular Pathology, said in an interview that the proposed regulations “would likely have resulted in diminished access to the tests by some patients because many labs couldn’t have afforded the costs associated with complying with those regulations.”
He added that problems cited by the FDA “were anecdotes, some of which came from newspaper reports. Many were outliers or part of questionable medical practice that would have occurred anyway.”
Some modern, complex LDTs are akin to medical devices, and that industry called for the tests to be regulated similarly to devices.
“As Congress weighs various proposals to reform LDT oversight, we urge lawmakers to recognize that FDA involvement does not mean a threat to patient access,” wrote AdvaMed, a medical device trade group, in a letter to Congress last April.
Michigan Representative Fred Upton, the Republican chairman of the House Energy and Commerce Committee, praised the FDA’s decision to delay, citing ongoing bipartisan discussions on an approach for how the agency should handle the tests.
“We appreciate FDA’s decision to refrain from finalizing its guidance on LDTs,” Upton said in a statement. “It was the right call. Our committee has consistently believed that applying medical device regulations to LDTs via non-binding guidance documents is not the best approach.
“Diagnostics, regardless of whether they are developed in a lab or by a manufacturer, are critical to advancing precision medicine and raise complex policy issues the committee has been grappling with on a bipartisan basis,” he said. “We look forward to discussing our efforts to date with additional stakeholders and completing our work next year.”
Senate health committee chairman Lamar Alexander, a Tennessee Republican, said in a statement, “I am glad that the FDA has listened and will delay making final its current draft guidance that could have halted more than 60,000 lab-developed tests in their tracks, and will work with Congress and the new administration on next steps.”
Sharon Begley contributed reporting.
This article is misleading. These tests are already regulated by a program within CMS, third party organizations, and states. The question that policymakers hoped to resolve is whether the CMS program should be enhanced or whether the FDA should expand their regulatory activities to include these services.
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