Who protects consumers from negligently manufactured or dangerous drugs and medical devices? Is it the FDA? In part, yes and in part, no. The FDA, because of the way in which it was designed to operate, could be said to be analogous to the “fox guarding the hen house”.

In order to fund the operation of the FDA, half its budget comes from fees paid by manufacturers to facilitate a speeding up of the approval process for new drugs and medical devices. In fact, it is understandable that some of the scientists at the FDA see the pharmaceutical and medical device manufacturers as more “their clients”; than they do the consumer. This understandably creates a situation where FDA scientists feel like a part of the drug or device approval “team”, more than a part of the consumer’s police force.

The FDA review process for new drugs and medical devices has been described by some courts as “rigorous”. My experience is that the approval process can be rigorous, but is sometimes not discerning enough on the part of the FDA. Through the Pre-Market Approval process (PMA) manufacturers are supposed to submit detailed information and provide the FDA with “reasonable assurances” that the drug/device is effective and is safe for the consumer. The PMA process provides for differing levels of scrutiny on the part of the FDA. Devices, for example, are broken down into Class I, Class II, and Class II devices. Class I devices are supposed to be those that present the minimal potential for harm to the consumer and are often much more simple in design.  Class II devices are similar to Class I, but are held to a higher level of assurance that they have a lower expectation of causing harm to the consumer; but they are subject to more regulation, often in terms of labeling, performance standards and post market surveillance. Class III devices require the most rigorous clinical and scientific documentation. The Class II review process requires the FDA to evaluate the “probable benefit from the use of the device against any probable risk of injury or illness from such use. 21 USC Sec. 360c (a) (2)(C).”

It is accepted that the FDA may grant approval to drugs and devices that they know may have some level of known complications associated with them, but the benefits of the drug/device make the potential complications acceptable. The problem often lies in product defects the manufacturer knows and fails to disclose to the FDA; or what the manufacturer should have clearly known but did not conduct analysis which was sufficient to discover.

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