Three US consumer groups have voiced their opposition to the recent nomination of acting US Food and Drug Administration commissioner, Lester Crawford, as head of the agency [[15/02/05a]], questioning his leadership of the FDA at a time when it has come under fire for failing to properly ensure prescription drug safety.
In a joint letter to the US Senate Committee on Health, Education, Labour and Pensions, the Consumers Union, the Consumer Federation of America and US Public Interest Research Group, said that “the agency’s high profile missteps, and failure to take timely action to protect consumers from unreasonable drug safety risks, have raised serious questions about his leadership, his ability to manage interagency conflicts and willingness to act in the best interest of consumers.” The groups called on the HELP committee to “ask, and get answers to, important questions about Dr Crawford’s record at FDA and his plans to achieve meaningful drug safety reform as commissioner.”
The groups highlight the recent high-profile withdrawal of Merck & Co’s top-selling painkiller, Vioxx (rofecoxib) [[01/10/04a]], and the questions over other drugs in the same class that have arisen as a consequence [[21/02/05a]]. “In the face of widely publicised regulatory shortcomings at [the] FDA, Dr Crawford has not acknowledged the need for substantive changes to increase the FDA’s ability to protect consumers. Though he claims to have a bold vision for the FDA, the question is whether or not [he] is committed to achieving substantive rather than symbolic drug safety reform,” the letter adds.
The groups also slammer the recent announcement that the FDA was planning to set up a new independent drug safety board [[16/02/05a]], saying that the move did “nothing to improve the agency’s weak regulatory capacity or to address the inherent internal conflicts of interest that prevent FDA from identifying unreasonable safety risks and taking timely action to protect the public from them.”
In his defence, Dr Crawford said: “I am committed to addressing existing concerns regarding post-market safety of FDA-regulated products.”