Trump administration blocks FDA from regulating lab-developed tests

The Department of Health and Human Services this week blocked the Food and Drug Administration's ability to regulate lab-developed tests, including for the coronavirus, that have been produced by hundreds of hospitals.

What they're saying: The change prohibits the FDA from overseeing such tests before they're marketed without a detailed rule-making process. HHS said it is taking the action as part of broader Trump administration review of "duplicative actions and unnecessary policies."

Why it matters: As the U.S. struggles to manage COVID-19 testing, the policy shift has public health experts surprised and worried that it could lead to unreliable coronavirus tests making their way onto the market, the Washington Post notes, adding the FDA opposed the change.

• Rep. Frank Pallone Jr. (D-NJ), chair of the House Energy and Commerce Committee, which oversees the FDA, called the decision “deeply concerning and suggests that the Trump administration is once again interfering with FDA’s regulation of medical products.”
• The FDA argued that a number of cases, including some flawed tests for Lyme disease and heart conditions, show why the lab industry must be regulated.

The other side: Supporters said the change, announced Wednesday, could allow innovative tests to reach the public more efficiently, and countered that the FDA's process slowed testing at the start of the pandemic. Advocates further argue that the FDA doesn't have the authority to regulate lab-developed tests.

Between the lines: This move serves as an example of "health agencies [having] been undercut by political overseers," The Post writes.

Flashback: Early in the outbreak, critics said the FDA was too slow and bureaucratic in its review process of lab-developed coronavirus tests.

• But starting in late March, the FDA told hospitals they could make tests without prior FDA approval, adding medical centers could use their tests and the agency would assess after the fact.

The impact: The tests most affected by the latest policy are those used at labs regulated by the Clinical Laboratory Improvement Amendments program, which is overseen by HHS's Centers for Medicare and Medicaid Services. Such labs are found in academic medical centers, smaller commercial labs and organizations including Quest and LabCorp.

The bottom line: "The FDA regulation of laboratory-developed tests has long been a gray area," the Post writes.