Congress Presses FDA To Curb COVID-19 Testing Fraud

By Al Barbarino
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Law360 (April 29, 2020, 5:37 PM EDT) -- A congressional subcommittee is demanding that the U.S. Food and Drug Administration help curb what it says is a "flood" of fraudulent coronavirus tests and has singled out four companies regarding the reliability of their tests.

The FDA has "failed to police" the coronavirus serological antibody test market, the chairman of the House Subcommittee on Economic and Consumer Policy wrote in a letter to the federal agency on Tuesday, adding that federal regulators must put forth guidelines through which they can approve tests before they hit the market.

"The subcommittee is concerned that FDA is not conducting a substantive review of serological tests that it has allowed on the market and that those tests may not meet a reasonable standard of accuracy," wrote Rep. Raja Krishnamoorthi, D-Ill., in the letter.

A subcommittee investigation found that the FDA had not reviewed any antibody test kits before they hit the market, and that a lack of enforcement has allowed manufacturers to make fraudulent claims about their efficacy, Krishnamoorthi said.

He said companies are ignoring government requests to voluntarily submit tests for validation, and that the failure to put forth proper regulations is creating a national hazard as plans to ease COVID-19 restrictions are hashed out.

"White House plans to reopen [the] economy are flawed by their dependence on coronavirus antibody tests, which face unanswered scientific questions of utility and accuracy," Krishnamoorthi wrote.

Krishnamoorthi rattled off four separate letters to companies that manufacture or distribute the tests, stating that their tests do not meet the performance standards claimed in their package inserts.

The letters to the CEOs of the companies — North Carolina-based BioMedomics Inc., Minnesota-based Premier Biotech Inc. and California-based UCP Biosciences Inc. and Epitope Diagnostics Inc. — noted that their tests were not listed among the 150 tests on the FDA's website as being marketed under its Pathway D policy.

The March 16 policy said that manufacturers could distribute the coronavirus serological tests, which measure blood antibodies as the body responds to infection, as long as they had validated the test, notified the FDA, and told patients about the lack of FDA-review.

Krishnamoorthi noted that FDA Commissioner Dr. Stephen Hahn, during an April 24 White House coronavirus press briefing, reaffirmed that the agency is taking a flexible approach and would rely on companies' self-validations.

"It is FDA's job to protect the public health. Abdicating that responsibility and trusting private industry to regulate itself is unacceptable," Krishnamoorthi wrote.

He argued that a study from a group including the University of California San Francisco confirmed that "the FDA's lax policies are permitting a flood of fraudulent tests onto the market."

The researchers independently examined the performance claims from the package inserts of the four tests and found that they had "a much higher risk of false negatives" than the companies indicated.

"The subcommittee has concerns about the reliability of your company's tests," Krishnamoorthi wrote in the letters to each company, calling the discrepancies in the performance data "deeply troubling."

More broadly, the researchers found that 11 of 14 serology tests analyzed did not deliver consistently reliable results and pointed to an earlier Feb. 4 emergency authorization from the U.S. Department of Health and Human Services that had also said certain tests could be offered based on manufacturer reported data and without formal FDA clearance.

"In response, dozens of companies have begun to market laboratory-based immunoassays and point-of-care tests," the researchers wrote, adding that "rigorous, comparative performance data are crucial to inform clinical care and public health response."

Krishnamoorthi requested that the FDA respond to questions by May 6 stemming from an April 17 briefing the agency gave the subcommittee, including whether the agency will commit to revising its policies on the testing. The subcommittee wants the FDA to enforce that companies submit test validations to the agency for approvals to help ensure that only effective tests hit the market.  

Krishnamoorthi also asked the individual companies to submit to the subcommittee by May 11 all communications with the FDA regarding their tests as well as all testing data and documentation provided to distributors and end-users, including brochures, test packaging, package inserts, instructions for use and fact sheets.

The FDA and the four companies did not immediately respond to requests for comment.

--Editing by Emily Kokoll.

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