For the first time, the United States Food and Drug Administration has publicly admitted that politics has trumped science. The agency acknowledged yesterday that it approved a device to assist with knee replacement surgeries-a-own scientific agency device often failed only after receiving pressure from a cohort of members of the New Democratic Congress Jersey, where the device manufacturer is.
$ 3000 the device was known as Menaflex name, "collagen scaffold" that supported a damaged knee meniscus. It failed its initial reviews, but was approved in December of last year anyway, in the last days of the Bush administration. In a new report, the FDA cited pressure from Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman as a decisive factor in getting approval: "The Director of the FDA's Office legislation described the pressure of [Capitol] Hill as the most extreme he had seen and the acquiescence of the body at the request of the Company to access the Commissioner and other officials in the commissioner's office as unprecedented in his experience. "
Moreover, former FDA chief Dr. Andrew C. von Eschenbach, spoke to the approved device.
According to New York Times , the company that manufactured Menaflex, ReGen Biologics Inc. , recently made campaign contributions to the four members of Congress. The Times added that thirty patients in the United States received the Menaflex and 3000 in Europe. U.S. News & World Report noted that, while acknowledging that the approval process has been compromised, the FDA has not currently scheduled to remove the device market.
A chronology of the process is available on the website agency. The agency announced that it has asked a committee established by the National Academy of Sciences to review the overall process of prior authorization for the marketing of medical devices.
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