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The Food and Drug Administration moved Friday to regulate a wide range of medical laboratory tests, including tests to diagnose cancer and detect abnormalities in fetuses, saying some tests are unreliable and could harm patients.
In announcing a proposed rule, the agency said it wanted to phase in regulation of laboratory testing the next five years to ensure their safety and effectiveness. It’s a multibillion-dollar industry involving so-called laboratory developed tests (LDTs), which are developed and used in a single laboratory as screening and diagnostic tools.
“These widely used tests generally do not come to the FDA for review,” FDA Commissioner Robert M. Califf said during a call with reporters. Califf called the situation “one of the biggest gaps” in the United States health care system — one that could lead to patients making poor treatment choices based on poor information.
If the rule is final, the FDA would likely require that at least some of the tests undergo regulatory review before being offered to patients. This would likely include cancer-related testing and genetic prenatal screening, experts said. Currently, LDTs are not required to be approved by the FDA.
The plan is already facing opposition from groups representing academic medical centers, which often develop their own tests, and from large commercial laboratories. They argue that FDA regulation would stifle innovation.
“It is not in the best interest of patient care to delay innovation” to help treat cancer and other diseases, said Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include clinical laboratory giants LabCorp and Quest Diagnostics.
Van Meter said LDTs are not medical devices like pacemakers or stents and should not be regulated as such. She said there is a role for the FDA in LDTs, but that Congress needs to define it.
Legislation to modernize the regulation of LDTs failed last year amid a whirlwind of competing interests. The failure of the legislation led the FDA to move forward with its own proposal.
Peter G. Lurie, president of the nonprofit Center for Science in the Public Interest, praised the FDA’s proposal.
“This is a big deal,” said Lurie, a former FDA official who was involved in the lab testing issue during his time at the agency. “This is one of the major remaining regulatory gaps at the FDA, and it has made significant efforts to close it.”
Some experts predicted that critics would try to block any final rule by suing the FDA.
The Centers for Medicare and Medicaid Services regulates clinical laboratories on topics such as: Cleanliness, but does not monitor the accuracy of laboratory tests. Some laboratory tests are already regulated by the FDA and are subject to regulatory review. They are made by testing equipment manufacturers such as Roche and Abbott, which sell the tests as kits to hospitals and other laboratories.
Decades ago, LDTs were relatively simple, but they have become increasingly complex. According to the agency, the tests can now be used to measure a variety of substances, including cholesterol, glucose and DNA. They can also provide information about which chemotherapy might be effective against cancerous tumors.
The FDA has repeatedly expressed concerns that LDTs pose increasing risks to consumers. In 2015, the agency released a report on 20 case studies involving substandard LDTs that could potentially harm patients. Last year, the agency warned patients and health care providers about inaccurate results from genetic noninvasive prenatal screening tests. Such tests are becoming increasingly popular.
The nonprofit Friends of Cancer Research’s research has found significant differences in diagnostic tests used to detect cancer Patients who are most likely to benefit from immunotherapy, which helps the immune system fight cancer. The group advocates increased regulation.
“The stakes are high in oncology,” said Jeff Allen, the organization’s president and chief executive officer. If the test results are incorrect, “you could forego a treatment that might help you” or choose one that doesn’t help.
The FDA has long argued that it has the legal authority to regulate the testing, but has not used that authority. The proposed rule would end this approach. But what exactly the new regime would look like remains uncertain.
While they made clear they want to greatly increase oversight of LDTs, FDA officials said Friday that they would consider alternative strategies that could result in some tests being grandfathered or some academic medical ones centers a different approach is chosen. They said they were reviewing public comments on the matter.
AdvaMed, a trade association whose members include Roche and Abbott, said in a statement that it supports greater regulation of LDTs but would prefer that Congress pass a law clarifying the FDA’s powers.