Back to School: How biopharma can reboot drug development. Access exclusive analysis here

BioCentury is providing this content for free given the urgent need for information about the coronavirus crisis. Further analysis can be found in our COVID-19 Resource Center. For more, sign up for our daily email.
1007 LDT FAQ
BioCentury & Getty Images

Politics, Policy & Law

FDA to stop reviewing COVID-19 lab tests, raising concerns in Congress 

As agency drops voluntary reviews of LDT EUAs, lawmakers worry about accuracy of tests

As agency drops voluntary reviews of LDT EUAs, lawmakers worry about accuracy of tests.

Oct 7, 2020 | 8:24 PM GMT

In a move that raises concerns about the accuracy of tests, as well as liability protections for laboratories, FDA announced Wednesday that it will no longer review emergency use authorization requests for laboratory-developed tests to diagnose COVID-19.

The announcement precludes even voluntary regulatory oversight over tests that are critical links in the chain of pandemic public health response.

FDA’s refusal to review COVID-19 LDTs could create problems for laboratories because it may remove liability protections that are associated with public health emergencies.

The policy is also raising concerns on Capitol Hill. 

The Wednesday announcement follows an Aug. 20 decision by HHS rescinding the agency’s authority to require premarket review of COVID-19 LDTs. That was made by HHS Secretary Alex Azar, who cited President Donald Trump’s de-regulatory policies. The HHS announcement did not cite any public health benefits.

When it revoked FDA’s power to require reviews of LDTs, HHS stated that LDT providers could “voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions.”

In an FAQ issued Wednesday, the agency precluded voluntary submissions of COVID-19 LDTs, stating that “to make the best use of our resources for the greatest public health benefit, FDA is declining to review EUA requests for LDTs at this time.”

In an analysis published on Aug. 24, Kyle Faget, an attorney at Foley & Lardner, wrote that “bringing an LDT to market without securing FDA premarket approval or clearance of, or an emergency use authorization (EUA), comes at a steep cost to clinical laboratories. Public Health and Emergency Preparedness Act (PREP Act) protection is not available to clinical laboratories opting to use LDTs without FDA premarket review or authorization.”

The PREP Act provides immunity “from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure” if the federal government has declared a public health emergency.

The agency said it will prioritize review of EUAs for COVID-19 point-of-care tests, home collection tests and at-home tests, as well as “tests that reduce reliance on test supplies, and high-throughput, widely distributed tests.”

FDA has not received an EUA application for a home test with sufficient data to merit review, Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, said Wednesday at the Food and Drug Law Institute annual meeting.

‘A grave error’

Congressional Democrats criticized the Trump administration’s LDT policy.

Reps. Frank Pallone Jr. (D-N.J.), chairman of the Energy and Commerce Committee, Anna Eshoo (D-Calif.) and Diana DeGette (D-Col.) told Azar in a letter that he has “once again committed a grave error in overruling objections of career scientists at the Food and Drug Administration (FDA) by announcing that HHS would allow marketing of laboratory-developed tests (LDTs) without FDA review.”

The letter cites a New England Journal of Medicine article by Stenzel and CDRH Director Jeffrey Shuren that reported that FDA had identified design or validation problems in about 66% of the COVID-19 LDT EUA applications it had reviewed.

In most cases, when FDA identified a problem with a COVID-19 LDT it “worked with laboratories to correct the issues and permit continued testing,” Shuren and Stenzel wrote. 

The decision to abandon LDT reviews “will increase the chances of false negative results, endangering countless lives, and weakening our understanding of COVID-19 as we head into fall and winter,” Pallone and colleagues wrote.

The American Clinical Laboratory Association (ACLA) expressed opposition to FDA’s decision.

“Many of the tests that have been granted EUAs for COVID-19 testing are innovative, high-throughput LDTs that have reduced reliance on supplies and been integral to expanding testing capacity. These are exactly the kinds of tests that FDA has stated it wants to prioritize. ACLA believes the FDA should continue to allow labs to voluntarily submit EUAs for FDA review and authorization. Today’s announcement by the FDA creates unnecessary confusion.”

Internal opposition

The decision to prevent FDA from requiring reviews of COVID-19 LDTs was strongly opposed by FDA staff who believe it could open the door to inaccurate tests, current and former FDA officials told BioCentury.

Former FDA Commissioner Scott Gottlieb criticized the decision in an Aug. 22 Twitter thread. He stated that  “countless labs say FDA counsel [on COVID-19 LDTs] helped improve test quality. The process was efficient; FDA’s staff is highly responsive. On the flipside, there are issues with the quality of some tests. FDA’s oversight role is critical.”

Gottlieb added that as a result of the HHS decision, “FDA’s ability to protect public health could be challenged. FDA might not be able to provide critical advice to test developers or take needed enforcement actions against bad tests.” 

Gottlieb is a fellow at the American Enterprise Institute, a special partner at New Enterprise Associates and serves on the boards of directors of Pfizer Inc. (NYSE:PFE), Illumina Inc. (NASDAQ:ILMN), Tempus Labs Inc. and Aetion Inc.

Stenzel may have been alluding to the LDT controversy when he said Wednesday that the COVID-19 experience has demonstrated the “need for a common legislative framework to ensure that all tests are accurate and reliable.” 

Legislation pending in Congress, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, would create a level playing field for regulation of LDTs and in vitro diagnostics. The VALID Act is based on a proposal FDA staff crafted in 2018. 

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE