A former HHS senior official told the administration decided Wednesday to further relax the regulation of lab-developed tests is inconsistent with the role that Congress proposed FDA would play in governing its use during a public health crisis. The former official criticized the department for opening the door for tests that could not meet a regulatory standard that is already a “flexible and empty bar.”
“The tests that are likely to come on the market under this policy are many of those that are unreliable and could not” get emergency use authorizations, “the former HHS official told POLITICO. FDA first took a light touch and the secretary’s office ran away from even a basic public health duty they owed doctors and patients. ”
In 2019, the FDA warned a lab in Virginia for illegal marketing of genetic tests that claimed a patient’s response to specific treatments without data to justify the findings. But some industry advocates and test developers reject the idea that the FDA has jurisdiction over LDTs, arguing that the tests are more like medical procedures than medical devices.
Jeffrey Shapiro, a medical device lawyer at Hyman, Phelps & McNamara, called the announcement “a win for clear, rule-based administrative law.”
Julie Khani, president of the American Clinical Laboratory Association, said that group is still testing the new HHS policy. ACLA, which represents commercial labs, has historically questioned whether the FDA has the legal authority to oversee LDTs.
“Any regulatory framework for testing developed by the laboratory should ensure continuous innovation, while guaranteeing public confidence in the accuracy and reliability of test results,” said Khani.
But others doubt the timing of the decision.
“In general, if you have an administration with a deregulatory curve, it’s not surprising to see that they’re trying to reduce the burden,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis. Louis. “What’s more surprising is doing it in the midst of a pandemic.”
Sachs notes that the FDA ran into problems earlier this year when it allowed companies to sell coronavirus antibody tests without agent estimates. The agency eventually reversed that decision after inaccurate and unreliable tests flooded the market.
FDA diagnostics director Timothy Stenzel has held weekly talks with laboratories and diagnostic manufacturers since late March to address questions about how the agency regulates coronavirus testing. The agency has delivered 35 authorizations for emergency use for laboratory-developed tests to date.
Senior administration officials maintain that the FDA still has the ability to restrict the use of inaccurate or unreliable tests, CMS still regulates the operation of clinical labs. And labs developing tests can still apply to the FDA for an emergency use authorization, which gives them some protection against lawsuits under the PREP law.
