FDA Admits Politics Trumped Science on Knee Device

The FDA has now admitted that four members of Congress from New Jersey -- Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman. Is it too much to ask if other items approved by the FDA have been done at the request of members of Congress or the President? How safe are the American consumers when an agency like the FDA bows to political pressure?

Sep 25, 2009

FDA Admits Politics Trumped Science on Knee Device
by Sam Kean

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.”

(Excerpt) See ScienceMag.org for Full Article