In mid-August, HHS abruptly announced that FDA was blocked (by HHS) from reviewing LDTs. (See entry point and links here).
Letters from House to HHS
On October 7, several legislators in the House released a public condemnation of this decision, via a press release and via a public letter to HHS Secretary Alex Azar. See the six-page public letter here. The press release is clipped below the break.
More: FDA Stops EUA Review for Local LDTs
Also on October 7, FDA announced that it would not review LDTs for COVID EUA status - here.
This latter FDA move is important because some COVID testing laws for commercial insurers and payments depend on whether tests have been FDA-reviewed (e.g. cleared, approved, or EUA). See page 3-4 at this HHS PDF here.
Regarding FDA stopping LDT review for EUAs, articles here and here. It's been suggested that FDA wants to prioritize review of POCT and high-throughput IVD tests, rather than local LDT tests. "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," stated OIVD director Tim Stenzl. "We are currently in a different phase of the pandemic with respect to tests than we were previously," he added.
Back Story: HHS Memo to End LDT Review
The House letter cites an October 2 Politico story that revealed a 17-page legal memo drafted at HHS that undercut FDA's arguments it had statutory authority to review LDTs in the first place. Politico here, PDF of memo released here. (24 mb). The legal memo dates to June 22. It amounts to a master class in FDA history regarding LDTs, written toward the endpoint that FDA can't regulate LDTs.
There is also a "two-pager" FAQ at HHS about the recent changes in FDA and LDT policy (here). The FAQ notes (its last question) that FDA review is required to get certain legal benefits for COVID tests.
I've bundled some key documents in one zip file in the cloud, here
FOR IMMEDIATE RELEASE
October 7, 2020
Pallone, Eshoo, DeGette: Azar’s Overruling Scientists on LDT Coronavirus Tests was a Grave Mistake
Democrats’ Warning Follows Major New Announcement that FDA Will No Longer Review LDT COVID-19 Tests Even if Requested by the Developer
– Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) wrote
to Health and Human Services Secretary Alex Azar today raising serious concerns over his decision to overrule career scientists at the Food and Drug Administration (FDA) by announcing that the Trump Administration would allow laboratory-developed tests (LDTs), including those for COVID-19, to come to market without FDA review. In a major policy announcement earlier today, FDA announced that it will no longer be reviewing LDTs, even if requested by the lab sponsor, following the decision by Secretary Azar.
“For months, the Administration has failed to take responsibility for developing and implementing a national [COVID-19] testing strategy, which has resulted in uncontrolled spread of the virus and continuous supply chain problems,” Pallone, Eshoo and DeGette wrote to Azar. “We now believe you have once again committed a grave error in overruling objections of career scientists at [FDA] by announcing that HHS would allow marketing of [LDTs] without FDA review. This new policy, which was made without prior notice or warning, could lead to numerous faulty tests on the market, raising serious concerns about the reliability of tests used to detect COVID-19.”
While FDA has often exercised enforcement discretion for LDTs, the agency has historically required laboratories to seek authorization prior to marketing LDTs during public health emergencies, such as the COVID-19 pandemic.
According to a recent article by FDA Directors Jeff Shuren and Timothy Stenzel in the New England Journal of Medicine, many of the COVID-19 LDTs reviewed by FDA proved to have performance problems or were poorly validated. They also noted that out of 125 Emergency Use Authorization requests, FDA identified 82 with design or validation problems—nearly 66 percent of such requests.
“We are disappointed that rather than follow this safer, more constructive approach, political leadership at HHS has chosen a reckless path, removing the requirement for LDTs to receive any review by FDA prior to their use during the worst pandemic of our lifetimes,” Pallone, Eshoo and DeGette continued. “This decision 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.”
In their letter, the Democrats also raised concerns that HHS reportedly moved forward on the policy change before FDA developed a plan for communicating the change or developed contingencies to deal with the consequences of the change. Numerous questions remain about how the policy will affect test developers, health care providers, and patients. In a highly unusual move, HHS made the announcement by posting a one-paragraph statement online, noting the announcement was created by Assistant Secretary for Public Affairs Michael Caputo, an official with no background in health care or diagnostic testing.
As part of their inquiry, the Committee leaders requested answers to a series of questions surrounding Azar’s decision to change LDT policy by October 21, 2020.
To read the full letter, click HERE