Abramson Smith Waldsmith LLP
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Why is the FDA tightening regulations for lab tests?

On Behalf of | Oct 4, 2023 | Defective Products

The Food and Drug Administration (FDA) plans to increase the regulation of laboratory medical tests because thousands of tests might be showing inaccurate results. The government agency wants to ensure these lab tests can accurately diagnose illnesses so patients receive proper treatment. The regulations also aim to reduce health care costs that stem from ineffective tests with misleading claims and false advertisements.

Because the manufacturing companies that develop these laboratory tests seem to focus more on quality than quantity, the tests are not as reliable as they should be. An incorrect diagnosis can have severe consequences on an individual.

What happens when a patient gets an incorrect diagnosis?

Large and well-established manufacturing companies sell a variety of lab tests to hospitals, physicians and pharmacies. The health care providers use these tests to streamline the diagnosing process. However, patients have received inaccurate results for “heart disease, Lyme disease, cancer and other conditions.” Faulty and defective tests lead to misdiagnoses. Here are the risks and consequences of a misdiagnosis:

  • The patient will not receive treatment for a condition that the test did not detect.
  • The patient will receive unnecessary treatment for a condition the test inaccurately detected.
  • The test might show results for another illness the patient did not initially have.
  • The health care provider prescribes the wrong medication to the patient because of the test results.

The patient’s condition may worsen because they are not receiving proper treatment. They might also suffer from preventable side effects from receiving harmful medication not intended for their medical condition. Imagine if a health care provider determines a patient requires surgery based on inaccurate results. Manufacturing companies have a legal obligation to test these tests before offering them for public consumption.