FDA Moving Forward with LDT Regulation: The Hill
Despite objections from congressional Republicans, FDA is moving ahead with plans to finalize guidelines for regulation of laboratory-developed tests by the end of this year, according to the online political Web site The Hill. The report says that Republicans on the House Energy and Commerce and Appropriations committees warned FDA not to overreach since a draft guidance was released in 2014.
“One of the things that has always bothered me about FDA’s objections is that you have to assume that a doctor would not exercise good clinical judgment,” The Hill quotes Rep. Michael Burgess (R-TX), an obstetrician, as saying. “If they got a laboratory test that didn’t match the symptoms and required more research or study, of course they would do that. This is a pretty important tool that has grown in recent years, and I’m worried that putting it under FDA is actually going to be detrimental. Take the Zika virus. We need these rapid diagnostic tests that are likely to come from people that are working on this issue. If they need to go through the whole regulatory process with FDA, with significantly less certainty their test will be approved, it is going to make it more difficult to get those rapid diagnostic tests we need so desperately.”
The article also says that House Energy and Commerce Committee chairman Fred Upton (R-MI) and Health Subcommittee chairman Joseph Pitts (R-PA) have said that the agency should not regulate the tests through new guidance. In its report on the FY 2017 agriculture spending bill (that includes FDA), the House Appropriations Committee called on the agency to suspend the guidance and help Congress draft regulatory legislation.
“Such a shift deserves input from the public,” the report says, “and Congress has been working with stakeholders, constituencies, and FDA to find common ground on regulating [the tests]”. “FDA’s guidance circumvents the normal rulemaking process and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988.”
The Hill says that the new FDA regulation would classify tests based on risk, with standards for approval mirroring the current medical device classification system. The first targets for review would be tests that have the same use as other approved Class 3 medical devices, along with tests used for blood products or to test blood safety. The tests would need to be submitted for premarket review within a year of the finalized guidance, it says.