By Daylin Delgado

The Food and Drug Administration (FDA) has been targeting inaccurate medical tests that have provoked unnecessary abortions, surgeries, prescriptions and an increase in medical costs. In the growing industry of laboratory-developed tests, the federal administration has been searching for ways to regulate and create stricter standards.

Some recent laboratory-developed tests haven’t been proven to be effective or reliable and yet being used. Without regulations, these tests are being used on patients that are then misinformed about their condition. The misinformation is the cause of several unnecessary procedures and increased medical costs for patients who are healthy or whose conditions are not fatal.

“Doctors and patients rely on these tests to make well-informed healthcare decisions. If they get inaccurate results, they can make the wrong decisions, and people get hurt as a result,” says Dr. Jeffrey  E. Shuren, director of the Center for Devices and Radiological Health at the FDA.

Common cases have involved blood tests to detect ovarian cancer; however, the blood test’s effectiveness was never evaluated. Inaccurate tests give back false-positive results that consequence in unnecessary surgeries, like removing healthy ovaries. Other cases have involved the detection of false abnormalities in pregnancies, resulting in abortions.

The Obama Administration is looking to enforce their authority, stating laboratory tests have become more complex and more like the commercial tests the government has regulated for over forty years. Republicans in Congress are working on legislation to establish firmer regulations as well.

The subject matter is a touchy area for conservative Republicans, while Democrats are generally supporting decisions to regulate. Republicans face difficulties with allowing the issue to turn over to a larger federal role; their belief is that the government is too big and costs too much.

“It is more likely the FDA will have a role in regulating laboratory-developed tests as a result of either congressional action or guidance issued by the agency,” says Jeffrey N. Gibbs, a lawyer for medical advice companies and laboratories.

The new standards, whether they are the result of the Obama Administration or Congress, will be the most significant change in laboratory regulations since 1988.