Coronavirus Testing Addressed in Bill on FDA Diagnostics Reviews

The coronavirus outbreak prompted lawmakers to add language on using tests for new diseases during an emergency as part of their long-awaited diagnostic test bill.

Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) released Thursday a bill to overhaul the regulation of diagnostics, culminating a three-and-a-half year effort to resolve differences among the various industries and federal agencies on how much oversight should be exercised over tests used to make treatment decisions.

The bill includes some grandfathering provisions and changes to technology certification compared to the draft issued in December 2018 and aims to make sure diagnostics are both accurate and useful to the patient who's being screened.

Sens. Richard Burr (R-N.C.) and Michael Bennet (D-Colo.) are introducing companion legislation, Bucshon said.

Amid changes that took years to iron out, Bucshon said they've inserted new language on an emergency use authorization. It builds on a Food and Drug Administration policy released Feb. 29 that allows an elite group of federally certified labs to use their molecular diagnostics tests without waiting for FDA authorization.

"We took a step back and we looked at how to best give labs and the developers the flexibility they need to develop diagnostic testing during public health emergencies," Bucshon said in an interview. That flexibility must be balanced with "trying to ensure the tests are valid and enable those to help be part of the response," he said.

Hospitals and laboratories must have the tools they need to diagnose patients accurately and quickly, DeGette, chair of the House Energy and Commerce Committee's oversight panel, said in an email.

"What we have learned over the years in successfully combating the spread of viruses, such as MERS, SARS and Ebola, is that time is of the essence," DeGette said. "This legislation will overhaul the federal government's outdated system that is slowing down our ability to respond to these threats—and it will ensure that hospitals around the country are able to begin testing patients for these potentially deadly viruses as soon as possible."

The Centers for Disease Control and Prevention faced heavy criticism for delays in distributing its COVID-19 coronavirus tests as cases increase in the U.S. "I think the CDC's going to learn from this. It's a unique situation," Bucshon said.

Bucshon said that while technical legislation like his bill is unlikely to pass on its own, it could be attached to must-pass FDA legislation to reauthorize the fees drug, biologics, and device industries pay in exchange for meeting performance goals. The current authorization expires in fiscal 2022.

"It'd be great if it could be a stand alone," he said. "If the rollout goes well and we have a really positive repose from members, there's a possibility it could be a standalone in an election year."

The bill would give the FDA new authority over diagnostics by creating a category of medical products called "in vitro clinical tests," which would allow it to oversee tests regardless of whether a laboratory or device company develops them.

FDA has historically exercised enforcement discretion over laboratory-developed tests (LDTs), but a move to change that policy in 2014 prompted an outcry from the laboratory industry, arguing they're already subject to the Centers for Medicare & Medicaid Services' Clinical Laboratory Improvement Amendments regulations. As tests became more complicated with their ability to screen millions of genes, the FDA said it needed to make sure patients and providers weren't making treatment decisions based on inaccurate information.

Bucshon said he believes the new bill has resolved those differences.

It includes a grandfathering provision to make sure that tests that people have already developed and are already on the market don't have to undergo FDA review—unless the test undergoes substantial changes that would change the evaluation of its accuracy and usefulness.

"Basically, a lot of tests are going to be grandfathered. So it's not going to make all those people go back and reinvent the wheel," Bucshon said.

A new technology certification would allow test developers to go through one review for the FDA to approve the underlying assay, but they won't have to go back for minor changes to the equipment.

There's also a clawback provision if there are problems with the test that present an unreasonable risk of substantial harm to the public. "It allows FDA to tell them to cease using the test, if it's found not to be accurate and causing health consequences," he said