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 security 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 also notes the agency has only 200 inspectors, who are responsible to oversee the 350,000 test 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 time, it works out to way too much work to be completed in way too little time.
The report cites examples of testing site violations going unaddressed for years at a time and, finally, being resolved via weakly worded enforcement letters. The lack of hands-on oversight, adequate manpower, and substantive penalties creates 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 if you choose to participate. If you begin to grow extra body parts, or glow in the dark, it may be time to reassess your commitment to the cause...To read more about the report, see this from Reuters. To learn more about the regulatory process, see this from the U.S. Food and Drug Administration.