October 4, 2013

Glucose Test Strip Accuracy Not Resolved

Will the Food and Drug Administration (FDA) actually do anything to insure quality in our test strips once they have approved them? Some people are hoping the FDA will take a stronger position and do more checking, but I certainly would not want to rely on this. I seriously would not even think they will do anything to enforce this. In the discussions to date, all they seem concerned about is the manufacturing plants and worry about how they will discover anything wrong with the test strips. This they claim because they announce that they are inspecting and the companies will be ready for them.

What I do not understand is why they must inspect the manufacturing facilities. Why isn't the FDA capable of walking into a pharmacy and purchasing a few vials of test strips and testing these? Oh, I had forgotten, this would cost money and the test strip companies are not putting up money paid to the FDA for continued certification. Therefore, the FDA will not likely do any further testing. Yes, the FDA will posture and say many things, but I seriously doubt any action will be taken.

It is easy for a FDA spokesperson to say, "Glucose meters have always been a priority for the FDA. This is an area that's complex, where lots of things happen… It's always been high on our list." Yes, Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health at the FDA did say this, but what does it mean? It just means that in the future, the FDA will seek assurances that the manufacturers will monitor quality control. With the attention drawn to strip safety, this is the preferred method of action. Notice how often this phrase “going forward” is used by all people speaking for the FDA. This is used to indicate everything is applicable... going forward, but means nothing in the present and is not a promise to do anything.

Katharine Serrano, diabetes branch chief, division of chemistry and toxicology devices, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health (CDRH) at the FDA, is quick to dismiss studies by Roche Diagnostics. Her statement, “However, any decision by the FDA to pursue regulatory action or change policy in this area would typically be based on a review of multiple sources of information on the post market performance of these systems," means that they are brushing off the Roche studies. Bold is my emphasis.

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