The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.
The FDA's internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions.
At issue isn't just the efficacy of the device -- that remains in dispute -- but the nature of the FDA's own approval process.
In one instance, emails show the FDA's integrity office excising language from a draft letter an FDA lawyer said would "document special treatment for ReGen." (Read the emails.)
Menaflex was approved under fast-track rules that don't require clinical trials needed under a full review. "There's something wrong with how that decision [to go the fast-track route] was made," said Andrew von Eschenbach, who was head of the FDA in December, when Menaflex got the go-ahead. "We fumbled that process."
Dr. von Eschenbach, who stepped down in January with the arrival of the new administration, is calling for an overhaul of the way the $200 billion-a-year medical-devices business is regulated. The fast-track system "has gotten out of control," he said.
President Barack Obama has yet to name his choice to run the FDA. Administration officials say they want someone to shake up what they see as the agency's culture of deference to companies. Industry groups, concerned that red tape could prevent new important medical advances from reaching market quickly, are lobbying for their own candidates.
More ...
