Diagnostic tests are used in countless hospitals across the country to help diagnose conditions. A test that can detect the onset of ovarian cancer in a person’s blood, for instance, can be life saving.
However, the Food and Drug Administration, the federal agency in charge of regulating food, drugs, tobacco and all things related to the medical and pharmaceutical industry, has expressed concerns over the reliability of some of these tests.
Amid the growth of commercialized lab testing facilities popping up across the U.S. that many hospitals and doctors have come to rely on, the FDA is proposing new rules to protect the safety of patient given these tests.
Present diagnostic test approval procedure
Under present law, the FDA must first conduct safety reviews and effectively test a medical test device made by a medical device maker before that device will be approved for sale and use on the market.
However, this law only applies to medical tests manufactured by device companies that intend to sell the product to everyone. If a test is developed by a private clinic or laboratory and sold for use strictly within that entity’s private use, it doesn’t need to be evaluated or approved by the FDA.
The FDA argues that this law should change and new regulations affecting all devices should be implemented. Technological advances are showing more and more tests not approved by the FDA are unreliable. In 2008, a test used to detect ovarian cancer was put on the market but was found giving faulty results just 4 months later.
The FDA has thus created a document outlining new standards that should be implemented regarding these medical devices and reasons why.
Likelihood of execution
However, according to recent reports, the Office of Management and Budget is still evaluating the proposal.
In November 2012, the Cancer Leadership Council, a cancer advocacy organization made up of cancer patient and research organizations, is also arguing for new rules.
The organization drafted a letter to the OMB encouraging them to take immediate action and allow the proposed guidance to move forward into the public comment stage. The letter stressed concern over doctors’ inability to safely rely on diagnostic tests utilized by current unregulated tests and the detriment that have and will continue to cause patients.
It’s unknown whether the recommendation will make headway in the OMB. In previous years, there has been difficulty getting regulatory proposals to pass through the office.
However, given the continued inaccuracy of these tests, the FDA and other patient advocacy groups aren’t likely to give up hope.