F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs

Source: By ROBERT PEARNOV, New York Times

November 23, 2015


A Genomic Health laboratory in Redwood City, Calif., in 2006. The company, which makes one of the diagnostic tests cited
by the Food and Drug Administration, disputed the criticism.
Credit Peter DaSilva for The New York Times

WASHINGTON — Inaccurate and unreliable medical tests are prompting abortions, promoting unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs, the Food and Drug Administration has concluded.

Life-threatening diseases go undetected in some cases. In others, patients are treated for conditions they do not have.

“Patients have been demonstrably harmed or may have been harmed by tests that did not meet F.D.A. requirements,” federal investigators concluded in a report to Congress last week.

The findings come at a time when the use of laboratory-developed tests is booming, the Obama administration is seeking new regulatory powers and even Republicans in Congress are working on legislation to set stricter standards. The new standards, whether set by Congress or by the administration, would be the most significant change in the regulation of laboratories since 1988, lawyers say.

In 20 case studies — half involving tests used to diagnose and treat cancer, others focused on heart disease, autism and Lyme disease — the F.D.A. laid out a compendium of serious problems.

Read more: http://www.nytimes.com/2015/11/24/us/politics/fda-targets-inaccurate-medical-tests-citing-dangers-and-costs.html