FDA Needs More Independence, Authority To Protect Consumers, NEJM Opinion Piece Says
Congress should give more independence and authority to drug safety oversight to help protect consumers from potential risks of medicines, Wayne Ray, Vanderbilt University researcher, writes in a perspective piece in Thursday's issue of the New England Journal of Medicine, Bloomberg/Arizona Daily Star reports. Ray, who has served as an expert witness in trials for liability cases for Merck's Vioxx and Bayer's Baycol cholesterol drug, suggests splitting the drug approval and safety functions that are currently housed under one FDA unit. In addition, he proposes a new Center for Drug Information, which would issue risk warnings for medications. Ray says that funding reorganization could be done through a tax on pharmaceutical sales. In addition, Ray suggests that the U.S. phase in sales of new medicines. Ray said that consumers "may be taking their medicines with a false sense of security. People should not put up with a system that does not protect them. They should ask Congress for change." Ray adds, "[L]itigation generates billions of dollars in legal fees and settlements that ultimately become part of the cost of new medications." He says that the legal process and the current way of releasing drugs after approval are "haphazard" and "[do] not benefit the public health, the medical profession or the pharmaceutical industry." Ray will present his points at a Tuesday meeting with the Institute of Medicine, which was asked by FDA to assess the agency's safety oversight and suggest changes. IOM plans to publish a report by midyear with suggestions for changes at FDA (Young, Bloomberg/Arizona Daily Star, 1/12).
The piece is available online.
