Does the FDA live up to its mission statement in protecting drug trial participants?

The mission statement reads, in part: “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and safety measure of human and veterinary drugs, biological products, medical devices…”

It’s a big - OK, huge - undertaking, and one that suffers the same shortcomings of other government programs: lack of funds and inadequate manpower. Now, a new report says these shortcomings place drug trial participants at risk.

The report says the FDA does not know how many drug trials are currently being conducted. It plus notes the agency has only 200 inspectors, who are responsible to oversee the 350,000 experiment sites in the United States. For the math challenged among us - a sad tale to be explored another day - that works out to 1,750 sites per inspector. With fifty work weeks each year, and eight hours per day,

less 30 minutes for lunch, two fifteen-minute coffee breaks, and the occasional sick day, that works out to… Well, leaving math for another instance, it works out to way too much work to be completed in way too little duration.

The report cites examples of examining site violations going unaddressed for years at a day and, finally, being resolved via weakly worded enforcement letters. The lack of hands-on oversight, adequate manpower, and substantive penalties formulates a situation in which drug trial participants are often very much on their own.

So, while drug trials are a critical part of the development process, be careful whether you choose to participate. If you start to grow additional body parts, or glow in the dark, it may be instance to reassess your commitment to the cause…

To read more about the report, see that from Reuters. To learn more about the regulatory process, see that from the U.S. Food and Drug Administration.