No FDA Review for Most Antibody Tests Draws Rebuke From Lawmaker

April 24, 2020, 10:39 PM

The Food and Drug Administration has allowed antibody tests that could show if someone has already been exposed to Covid-19 and developed some immunity to be on the market without its review and has yet to take an enforcement action, according to lawmakers.

President Donald Trump has touted antibody testing as a way to unlock the U.S. economy, and experts say it could be key in doing so safely. However, there have been reports that current tests could be unsafe or inaccurate.

The FDA hasn’t assessed the reliability of most of the antibody tests on the market, according to a memo by a subcommittee of the House Oversight Committee released Friday. The Department of Health and Human Services has convened an interagency group to do so, but the program is voluntary. Only seven of the 101 test kits on the market had been submitted as of April 17.

“Serology testing for coronavirus has the potential to be a critical tool going forward for our nation. Unfortunately, senior FDA and CDC officials admitted that they have not put Americans in the best position to use this tool,” the subcommittee’s chairman, Rep. Raja Krishnamoorthi (D-Ill.), said in a statement. “They have put the public’s health at risk by allowing inaccurate and potentially fraudulent tests to spread unchecked.”

The FDA asked the manufacturers of the 101 test kits on the market through the FDA pathway to submit that their tests were validated, but it didn’t require proof, the committee said.

The agency also hasn’t requested the packaging or marketing information from the companies to verify they complied with FDA marketing policy, the committee said.

Hahn: Consumer Notice Required

The FDA didn’t immediately respond to a request for comment, but FDA Commissioner Stephen Hahn was asked about the memo at a White House briefing Friday.

“What we’ve told manufacturers is that in order to market in the U.S. they have to validate their tests,” Hahn said. “They have to tell us that they’ve validated their tests. And in the package insert, they have to let people know—end users, labs, etc.—that those tests were not authorized by FDA.”

“We’ve authorized four. As I’ve mentioned, there are more in the pipeline,” he said.

Officials from the Centers for Disease Control and Prevention told the committee in an April 17 briefing that they have no plan to issue guidelines on who should receive a serology test and how to interpret it.

An FDA representative told the committee in the same briefing that the agency hasn’t “taken enforcement action yet,” but that it has informally emailed companies to correct some fraudulent marketing practices.

The FDA has clarified its policies to say that serology testing outside of Centers for Medicare & Medicaid Services-certified laboratories is not allowed.

The committee sent letters to Wellness Matrix Group, Vault Health and RUCDR Infinite Biologics, and ARCpoint Labs, which it said “offered at-home testing in violation of FDA policy.” The companies have refunded money they had collected and destroyed samples from customers, the committee said.

The CDC did not immediately respond to a request for comment.

—With assistance from Jeannie Baumann

To contact the reporter on this story: Shira Stein in Washington at sstein@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Brent Bierman at bbierman@bloomberglaw.com

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