The Food and Drug Administration is facing criticism following its controversial approval of a new device to treat knee injuries. The federal agency recently cleared Menaflex, developed by New Jersey-based ReGen, despite repeated rejections and concerns about the device’s efficacy. The Wall Street Journal reports that ReGen’s aggressive lobbying campaign on behalf of Menaflex is raising questions about corporate influence on the FDA.
Menaflex is a C-shaped implant designed to reinforce damaged or weakened tissue in the knee. The device was approved under the FDA’s fast-track rules, which do not require clinical trials for products that are similar to those already on the market. Scientists in the FDA’s medical-devices division had twice rejected ReGen’s initial application for fast-track status, arguing that Menaflex was a new kind of device that required extensive testing. ReGen contested the claims and appealed to New Jersey lawmakers, who facilitated a meeting with FDA head Dr. Andrew von Eschenbach. Among other requests, ReGen asked that the decision on Menaflex be turned over to the head of the FDA’s medical devices division, that sports-medicine experts be added to the Menaflex review panel, and that none of the scientists who had previously criticized Menaflex speak at the panel. According to e-mail records, the FDA’s integrity office drafted a letter to ReGen stating that they were taking the company’s criteria for the panel’s composition into consideration. An agency lawyer instructed them to delete the language used under the grounds that it would “document special treatment for ReGen.”
The requests were granted, and an eight-person committee approved the device in December. At least three committee members have since expressed reservations about the decision to fast-track Menaflex, and one scientist who was brought in to assess the device has voiced concerns about a lack of statistical evidence backing ReGen’s claims about Menaflex. Dr. Daniel Schultz, who headed the committee, has stated that while he found ReGen’s tactics “aggressive,” they did not influence his decision. ReGen stands behind their lobbying efforts, citing a desire for an unbiased panel and a need to confront delays caused by the FDA.
Von Eschenbach stepped down from the FDA in January with the change in administration. He, along with many other administration officials, believes the current FDA culture is too quick to defer to political and industry pressures. Von Eschenbach is calling for an overhaul of the device-approval process. Such an overhaul would challenge industry lobbyists, who are concerned that beneficial medical advances might not reach the public quickly. Von Eschenbach’s replacement has not yet been appointed.