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FDA proposes more regulation to avoid possible misdiagnoses

The Food and Drug Administration is charged with ensuring public safety from potentially harmful foods, medications and medical devices. Now, it is proposing additional oversight of certain laboratory testing in an effort to reduce the numbers of misdiagnoses than have been blamed on inaccurate test results. There may be some Massachusetts patients who were harmed by faulty or inaccurate results.

The FDA recently held a two-day seminar to discuss the agency's proposal. The agency expressed its intention to begin overseeing the development of a variety of tests that are produced by medical laboratories. Many stated opposition to increased regulation as it may add to the cost of testing and limit patients' access to tests that may have a direct impact on their future health. One association has challenged the authority of the FDA to even propose oversight of the development of these important diagnostic tools.

However, there are some who favor such government supervision. In the recent past, some female patients chose surgical removal of their ovaries based on erroneous tests that indicated the possible presence of disease. Now, more patients might be spared such consequences if the agency could ensure the accuracy of vital diagnostic testing. One group that supports the proposal is the medical device association. On the other hand, the American Medical Association stands opposed to any further interference in the development of lab manufactured tests.

There are already procedures in place that are meant to protect patients from inaccurate or faulty test results. Moreover, there are many who question how the FDA could provide any additional protection from misdiagnoses in light of the policies that have been instituted over the past four decades. For now, it is unclear as to whether the agency will in fact take action on its proposal. Massachusetts patients who have been harmed as a result of an inaccurate test or other mistakes on the part of their medical providers retain the right to file and litigate a medical malpractice claim in order to seek recompense for the monetary losses they may have sustained.

Source: modernhealthcare.com, "Proposed regulation of lab tests draws mixed reviews at workshop", Jaimy Lee, Jan. 9, 2015

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