A report released this week by the Government Accountability Office reveals that some of the most risky medical devices weren’t carefully reviewed by the Food and Drug Administration before they appeared on the market.

 

The report comes just a week after a group of nine scientists at the FDA sent a letter to President-elect Barack Obama and his transition team, asking for immediate intervention as the agency is “fundamentally broken” and fails to fulfill its mission.

 

The scientists went even further and said there is an atmosphere at the FDA in which the honest employee fears the dishonest one, when it should be the other way around. Moreover, the FDA has promoted and rewarded some of the managers involved with the inappropriate practices. They also complained about devices that have not been properly labeled, about managers without appropriate experience who have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns, or of FDA experts who have been excluded from product meetings because manufacturers felt that they were "biased."

 

Now, the GAO stated in the report that “it is imperative that FDA take immediate steps” to fix its system for approving devices.

 

The FDA’s process for approving devices was created in 1976. According to it, the products are divided in three classes and three levels of scrutiny. Class I devices include tongue depressors, reading glasses, forceps and similar products, which are largely exempt from the agency review. Class II devices include products like mercury thermometers, which usually get quick review. Class III devices include pacemakers and replacement heart valves. The problem is mostly with this class, as most of the products belonging to it are approved with minimal testing although it is important to check their efficiency.

 

“The combination of this report and last week's letter is a wake-up call to Congress and the incoming Obama administration: the FDA's Center for Devices is broken and needs a major overhaul,” said Diana Zuckerman, president of the health advocacy group The National Research Center for Women & Families.