FDA Focusing on Dangers and Costs of Bad Medical Testing

Unnecessary surgeries. Pointless prescriptions for expensive medication. Failure to diagnose and treat a serious illness. A decision to terminate a pregnancy. What do all of these things have in common?

Bad or inaccurate medical test results can cause all of them, and do with an alarming frequency, harming patients and increasing medical costs for everyone.

A recent report presented to Congress by the U.S. Food and Drug Administration (FDA) concluded that, “patients have been demonstrably harmed by or may have been harmed by tests that did not meet FDA requirements.”

The focus of the FDA’s concerns, and of their request for greater regulation and oversight, are “laboratory-developed tests” (LDTs) used to detect diseases or genetic conditions. LDTs are designed, manufactured, and used in a single laboratory, as opposed to other diagnostic tests made by a conventional manufacturer and used by many laboratories.

While LDTs were once used infrequently and only in very extreme cases, they are “now used to diagnose common, serious medical conditions, including cancer and heart disease. Others guide therapy for these and other conditions, while still others predict one’s personal risk of developing a particular disease” according to the FDA report.

The problem is that LDTs are not subject to the same strict requirements that other medical and diagnostic tests are. As the FDA notes, “while certain LDTs have undoubtedly brought benefits to many patients, the increase in complexity and patient volume brings a concomitant risk that patients will be harmed – and, in fact, have been harmed – and highlights the need for appropriate oversight.”

This lack of oversight has led to a number of problems with LDTs that put patients at risk according to the FDA report, including:

• Lack of evidence supporting the clinical validity of tests
• Deficient adverse event reporting
• No premarket review of performance data
• Unsupported manufacturer claims
• Inadequate product labeling
• Lack of transparency

How Congress responds to the report and the FDAs request for more regulation over LDTs remains to be seen. But at minimum the report highlights the need for care when taking diagnostic medical tests, evaluating their results, and making informed decisions that are based on the presumed accuracy of those results.

At The Parian Law Firm in metro Atlanta, Georgia, we represent injury victims exclusively and are committed to getting justice and compensation for our clients. Please contact us at (770) 727-5550 or chat live online with a member of our staff today.