Thoughts About the FDA

Posted by Anthony Lee Jun 19, 2009

Whenever you hear about new drugs, medical devices, or other kinds of products, you typically hear about the U.S. Food and Drug Administration (FDA), the regulatory body ensuring safety of these products for all Americans. Despite its purpose, the organization faces harsh criticism about not doing enough to keep the public safe. I have certainly noted this ever since Vioxx was pulled off the market in 2004.

I have never worked for the FDA, so I do not have close familiarity with its processes. I do, however, have some idea of how things work there, particularly the divisions responsible for approving drugs and medical devices. I know because I have read about them from the FDA web site. It helps me with my job as a medical technology consultant, because I review the U.S. regulatory status for new tests and treatments, not just the available scientific evidence.

I agree with the prevailing notion that the FDA needs improvement. Products should not be approved and then pulled off the market after safety issues arise. For me, medical devices are of special concern because these types of products have different approval procedures depending on their risk level. The simplest low-risk devices are typically exempt from approval while moderate-risk devices have a regulatory process that is less stringent than that applied to high-risk devices.

Besides the procedures, another major issue might be staffing. Each regulated product involves a ton of paperwork before marketing approval as well as post-marketing safety reporting if adverse events occur. If there are not enough people to handle the workload, approvals may be firm but slow or quick but risky.

Again, I'm not affiliated with the FDA, but this is my understanding of it. If there are any efforts to improve FDA oversight, I support them.