For the first time, the U.S. Food and Drug Administration has publicly admitted that politics has trumped science. The agency acknowledged yesterday that it approved a device to help with knee-replacement surgeries—a device the agency’s own scientists said often failed—only after it received pressure from a cohort of Democratic congressmen from New Jersey, where the device’s manufacturer is located.
The $3000 device was known as the Menaflex, a “collagen scaffold” that supported a damaged meniscus in the knee. It failed its initial reviews but received approval in December of last year anyway, during the waning days of the Bush Administration. In a new report, 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 gaining approval: “The Director of FDA’s Office of Legislation described the pressure from the [Capitol] Hill as the most extreme he had seen and the agency’s acquiescence to the Company’s demands for access to the Commissioner and other officials in the Commissioner’s office as unprecedented in his experience.”
In addition, the former head of the FDA, Dr. Andrew C. von Eschenbach, intervened to have the device approved.
According to The New York Times, the company that manufactured Menaflex, ReGen Biologics Inc., had recently made campaign contributions to all four Congressmen. The Times added that thirty patients in the United States have received the Menaflex and 3000 in Europe. U.S. News & World Report noted that, despite acknowledging that the approval process was compromised, FDA has no plans at the moment to remove the device from the market.
A timeline of the process is available on the agency’s website. The agency has announced it has asked a committee established by the National Academy of Sciences to review the general premarket clearance process for medical devices.