Although no significant improvements in drug safety occurred while he was FDA Commissioner from 2002 to 2004, Dr. McClellan now acknowledges the need for improved safety surveillance at FDA, in a commentary in the April 26, 2007 New England Journal of Medicine.
This issue contains several articles on FDA assessment of drug safety. Jerry Avorn, a Harvard professor of pharmacoepidemiology, noted that 4 former FDA commissioners have called for an end to industry funding of FDA’s new drug evaluations. As a result of industry funding, first introduced 15 years ago, FDA scientists were transferred from assessing drug safety to assessing new drug applications.
Dr. Avorn points out that FDA lacks the statutory authority to require companies to conduct follow-up studies of drugs after they are licensed. When FDA issues a new drug license, FDA is frequently very specific about the number and types of additional studies of safety and efficacy it expects to be performed. Yet despite this, the majority of postmarketing studies have not been done. According to the Federal Register, only 11% of 1,259 requested drug studies and 20% of requested biologics studies have been completed and reported on.
In 1970, at the time of licensure, the anthrax vaccine manufacturer was asked to conduct a clinical trial for efficacy, which never took place. Thirty-seven years after it was licensed, there is still no human efficacy data for the anthrax vaccine. (Don’t even ask me about the quality of the safety data, which FDA has chosen to ignore.)