Adhesiabloc: Fake Medicine Clears Initial FDA Approval Steps


As citizens of the United States, we hope and trust that government entities are always looking out for our best interests. However, in 2011, the Food and Drug Administration made a serious blunder that calls into question the FDA’s ability to keep us safe.

The United States General Accountability Office (GAO) became concerned that the FDA was passing along medications without truly reviewing them. To test the strength of our regulatory system, they essentially set up a sting operation. This involved the organization creating a fake company (Device Med-Systems) with a fictional product (Adhesiabloc). The GAO did not even try to make this sound like a real product. The description is as follows:

“A gel that would be poured into a patient’s stomach after surgery to collect the bits and pieces left over from an operation.”

What happened next in the FDA process is downright scary. The product was approved for human testing.

What many people do not realize is that the FDA itself does not evaluate potential products. Instead, these evaluations are contracted out to private companies called Institutional Review Boards. Here is another scary fact: these for-profit Institutional Review Boards are contracted and paid directly by the pharmaceutical and medical device companies they regulate. At the very least, this implies a serious conflict of interest that puts the health of consumers at risk.

When the Adhesiabloc product was introduced to the IRBs, two agencies did in fact turn it down for issues with the product application. However, a third agency indicated that the product would be safe for human use. It took almost six months for the issue to be noticed and addressed, and that only happened through an irregularity review of files at the approving IRB office.

What does this mean for Americans? We must find better ways to review and understand the products approved by the Food and Drug Administration.

We can hope that this sting created and implemented by the GAO was enough to get the attention of the FDA and its parent organization, the Department of Health and Human Services. However, history indicates that we as private citizens, businesses, and advocacy organizations must remain strictly vigilant over products released into our markets.