Lobbying, Industry Pressure Brought to Bear in Menaflex Knee Device ApprovalMar 6, 2009 | Parker Waichman LLP
The approval of ReGen Biologics Inc.'s Menaflex knee device may have had more to do with lobbying than it did with the product's merits. According to a report in The Wall Street Journal, scientists at the Food & Drug Administration (FDA) had repeatedly rejected Menaflex, but industry and political pressure led to its approval.
Menaflex is meant to repair a torn meniscus, which basically acts as a shock absorber for the knee. According to The Wall Street Journal, ReGen says that Menaflex promotes the growth of new tissue.
According to the Journal, Menaflex was approved under the FDA's 501(K) rules, which allow for a "fast-track" approval - normally reserved for devices that are similar to products already on the market. But the chairman of the FDA advisory committee that considered Menaflex told the Journal that there are no other products on the market like this device.
Under the fast-track process, devices don't have to undergo clinical trials. When ReGen first sought U.S. approval for Menaflex, it did so under the FDA's normal process, and initiated a clinical trial. But according to The Wall Street Journal, the FDA issued the company a warning letter that cited record keeping violations in the clinical trial. In December 2005, the company decided to go for fast-track approval.
However, ReGen also continued its troubled clinical trial. The FDA issued a formal warning to that trial in 2006 because of a conflict of interest violation. According to the Journal, a top ReGen executive was serving as vice chairman of a review charged with providing independent oversight of the trial.
In July 2008, ReGen announced that its clinical trials had been a success. But FDA scientists spotted problems with the device when they reviewed it. Sometimes, patients in the trial needed another operation after receiving Menaflex, and in some case, the device had to be removed, the Journal said.
Meanwhile, the FDA scientists charged with device approvals rejected the Menaflex fast-track bids in August 2006 and September 2007. According to the Journal, the rejections said that Menaflex was not eligible for the process.
The FDA's second rejection of ReGen's fast-track application for Menaflex prompted the company to appeal to several members of New Jersey's Congressional delegation. Three of them - Democratic Senators Robert Menendez and Frank Lautenberg, as well as Rep. Steve Rothman of Hackensack, also a Democrat - wrote to the FDA's commissioner asking that he personally review the approval process for Menaflex. Sen. Menendez even called the commissioner on behalf of the company.
As a result, ReGen was able to get a meeting with the FDA's commissioner, Dr. Andrew von Eschenbach, in January 2008. According to The Wall Street Journal, two days after that meeting, ReGen asked the commissioner to put the approval of Menaflex in the hands of Dr. Daniel Schultz, who was heading up the medical device division. The company also asked that FDA staffers who previously had opposed Menaflex be excluded from the decision-making process, the Journal said.
According to the Journal, ReGen pretty much got what it wanted, and Dr. Schultz took personal charge of the approval process. Shortly after that, FDA scientists recommended that the company's third fast-track bid for Menaflex be rejected.
That didn't happen. Instead, the Journals says Dr. Schultz convened a special panel to look at Menaflex. According to FDA documents, ReGen tried to influence who was on the panel - they recommended experts they favored, and lobbied to keep scientists who had been against approval off the panel . Another Democratic New Jersey lawmaker, Frank Pallone, also called the FDA to discuss the issue, because he felt the agency was "applying an inappropriate and possibly illegal standard", the Journal said.
In the end, the panel included five sports-medicine experts from outside the FDA's regular pool of experts. According to The Wall Street Journal, a letter to ReGen from the FDA noted that the inclusion of the experts was "per [ReGen's] request." And because ReGen had accused them of bias, none of the FDA scientists who had been critical of Menaflex were permitted to speak to the panel.
When Dr. Schultz summarized the meeting, the Journal said he wrote that the panel "clearly and unanimously" found Menaflex to be at least as effective as other surgical meshes on the market. But most members of the panel told The Wall Street Journal that wasn't the case. One panel member even told the Journal that had he known Schultz would approve Menaflex based on the panel discussions, he would have spoken out against it.
Schultz did end up approving Menaflex. According to the Journal, the device was formally introduced last week at a medical convention in Las Vegas.