“These widely used tests are not generally coming to the FDA for review,” FDA Commissioner Robert M. Califf said during a call with reporters. Califf called the situation “one of the most significant gaps” in the health care system in the United States — one that could cause patients to make the wrong choice on treatments based on bad information.
If the rule is finalized, the FDA would probably require at least some of the tests to go through agency review before being offered to patients. That would probably include tests involving cancer and genetic prenatal screening, experts said. Currently, LDTs don’t have to be cleared by the FDA.
The plan already is running into 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 lab giants LabCorp and Quest Diagnostics.
Van Meter said LDTs are not medical devices, like pacemakers or stents, and shouldn’t be regulated as such. She said there is a role for the FDA in LDTs, but that Congress should determine it.
Legislation to modernize the regulation of LDTs failed last year, amid a swirl of competing interests. The failure of the legislation prompted 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.
“It’s a big deal,” said Lurie, a former FDA official who was involved in the lab-test issue while at the agency. “This is one of the big remaining regulatory gaps at the FDA, and they have made a strong effort to fill 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 labs on issues such as cleanliness but does not monitor the accuracy of lab tests. Some lab tests already are regulated by the FDA and get agency scrutiny. They are made by manufacturers of testing equipment, such as Roche and Abbott, which sell the tests as kits to hospitals and other labs.
Decades ago, LDTs were relatively simple, but they have become increasingly complex. Today, the tests can be used to measure a variety of substances including cholesterol, glucose and DNA, according to the agency. They also can offer insight into 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 published a report of 20 case studies involving poor quality LDTs that potentially caused harm to patients. Last year, the agency warned patients and health-care providers about inaccurate results involving genetic noninvasive prenatal screening tests. Such tests have become increasingly popular.
The nonprofit Friends of Cancer Research, in its research, has found substantial variability in diagnostic tests used to identify cancer patients who are most likely to benefit from immunotherapy, which helps the immune system battle cancer. The group supports stepped up regulation.
“In oncology, the stakes are high,” said Jeff Allen, president and chief executive of the organization. If the test results are not accurate, “you could forgo a treatment that could help you” or choose one that won’t.
The FDA has long argued it has the legal authority to regulate the tests, but it has not used that power. That approach would end, under the proposed rule. But exactly what the new regime would look like remains uncertain.
While making clear that they want to sharply ramp up oversight of LDTs, FDA officials said Friday they would consider alternative strategies that could entail grandfathering some tests or using a different approach with some academic medical centers. They said they would review public comments on the matter.
AdvaMed, a trade association that counts Roche and Abbott among its members, indicated in a statement it supports increased regulation of LDTs but would prefer if Congress passed legislation spelling out the FDA’s authority.
