Public Citizen researchers on medical device safety

On Tuesday, Public Citizen researchers published an article in PLoS Medicine about the safety of various medical devices. The authors of the article found that the FDA approval process does not adequately weed out ineffective and sometimes dangerous devices. From the press release issued Tuesday:

The weaknesses identified by the authors include:

• A lower approval standard for devices than for drugs;

• Lax interpretation of the requirements for the medical device approval process;

• A loophole that allows manufacturers of novel devices to circumvent the premarket approval process;

• Failure of the FDA to appropriately regulate many types of devices that were first marketed prior to the 1976 enactment of the current regulatory scheme; and

• A superfluous appeal mechanism that gives manufacturers a second go for approval after FDA has rejected a device.

The authors enumerated specific cases where FDA allowed dangerous products to be sent to market. In one particularly egregious instance, a device was approved by the FDA director after other FDA board members had expressed significant concerns about the device, the vagus nerve stimulator, which is supposed to treat severe depression. Currently, the Centers for Medicare and Medicaid considers the device to be of such questionable value that it refuses to reimburse for it.

In the words of one of the researchers, Dr. Sidney Wolfe,

“The FDA’s mission is to protect public health, but allowing questionably effective products onto the market is inconsistent with that mission.”

The article can be found in the latest issue of PLoS Medicine.