FDA to finalize rules on lab tests over GOP opposition

Despite warnings from Congress, the Food and Drug Administration (FDA) is moving forward with plans to finalize guidelines by the end of this year for approval of high-risk lab tests, including next-generation sequencing and cancer screenings. 

The move to push forward puts the agency at odds with Republicans on the House Energy and Commerce and Appropriations committees, who have warned the agency not to overreach since the draft guidance was released in 2014.

{mosads}Improving oversight of the booming market for lab tests that screen for everything from strep throat to colon cancer and determine treatments has been the subject of hearings and legislation that gained no traction. The FDA says it must act to safeguard consumers, but critics see another regulatory power grab by the Obama administration.

“One of the things that has always bothered me about the FDA’s objections is that you have to assume that a doctor would not exercise good clinical judgment,” said Rep. Michael Burgess (R-Texas), a committee member and obstetrician. “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 a lot in recent years, and I’m worried that putting it under the FDA is actually going to be detrimental,” he said.

“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 then need to go through the whole regulatory process with the 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.”

House Energy and Commerce Chairman Fred Upton (R-Mich.) and Chairman Joseph Pitts (R-Pa.) of the health subcommittee have argued that the FDA should not regulate the test through new guidance. The House Appropriations Committee shared that sentiment, asking the FDA to suspend the guidance and instead help Congress draft regulatory legislation in its report on the fiscal 2017 Agriculture spending bill.

“Such a shift deserves input from the public, and Congress has been working with stakeholders, constituencies, and the FDA to find common ground on regulating [laboratory developed tests],” the report states. “The 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 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 will be tests that have the same use as other FDA-approved Class III 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 guidelines.

Not all laboratory-developed tests are in the crosshairs, though — just those that could cause serious harm to patients if they provide false results or fall short of their medical claims.

Burgess would prefer the Centers for Medicare and Medicaid Services step in and add premarket test validation to items regulated under the Clinical Laboratory Improvement Amendments (CLIA), which regulate clinical lab testing. He introduced a bill in 2011 to that effect, though it saw no action and has not resurfaced.

“If someone wants to talk CLIA modernization, in light of the fact there are so many more diagnostic tests, I’m happy to have that discussion,” Burgess said. “I’m willing to listen if someone says here are the problems with CLIA and why we have to do something differently, but moving into a realm of a much more tightly regulated process in a very promising and expanding part of medical diagnostics — I’m not sure I’m ready to do that just to conform to someone’s idea of regulatory science.”