March 9, 2009

Written complaints from senior U.S. Food and Drug Administration (“FDA”) staff members regarding the handling of Menaflex, a new medical device for treating knee injuries, are calling into question the validity of the FDA’s approval process. Specifically, FDA documents show that the recent approval of Menaflex followed a lobbying campaign that overcame multiple rejections by FDA scientists.

Menaflex is a C-shaped pad designed to treat meniscus tears, the most common type of knee injury. Traditionally, surgery has been used to sew up torn meniscus tissue, but with surgery, tears are likely to recur, which is why many doctors are eager to find a better way to repair meniscus tissue.

While ReGen, Menaflex’s maker, sought full FDA approval of Menaflex when it filed its original approval application in 2004, the company changed its application to seek fast track approval, avoiding the need to eventually present clinical trial data, after problems arose with a clinical trial of Menaflex.

In both August 2006 and September 2007, scientists in the FDA’s medical-devices division issued formal rejection letters concluding that Menaflex was not of “substantial equivalence” to existing devices and thus did not meet the FDA requirements for fast-track approval.

After the FDA rejected Menaflex for fast-track status the second time, ReGen sought help from New Jersey lawmakers. ReGen was able to get four lawmakers to sign a letter asking the FDA commissioner to personally review the matter, and with Congressional help, ReGen landed a personal meeting with the FDA commissioner.

The FDA commissioner handed the matter over to Dr. Schultz, head of the FDA’s device division, who took personal charge of the decision making process. A few months later, ReGen presented its third application for fast-track approval of Menaflex, and although FDA scientists once again recommended issuing a rejection letter, Dr. Schultz decided to assemble a special panel of outside doctors to decide whether Menaflex met the FDA’s fast-track requirements.

After Dr Shultz approved Menaflex in December 2008, some senior FDA staff members complained in documents that the handling of Menaflex shows how political and industry pressure can influence scientific conclusions. One email even shows the FDA’s integrity office removing language from a draft letter an FDA lawyer said would “document special treatment for ReGen.”

According to Andrew von Eschenbach, who was the head of the FDA when Menaflex was approved, “There’s something wrong with how that decision [to go the fast-track route] was made. We fumbled that process.”Dr. von Eschenbach, who stepped down in January 2009 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. In an interview with the Wall Street Journal, he said the fast track system “has gotten out of control.”

While President Barack Obama has not yet named who will be the next person 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.

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Published November 17, 2011 by