Fda Admits Menaflex Knee Device Approval Flawed

The Food and Drug Administration has for a while now been battling allegations related to the approval of a knee device, Menaflex. This week, the agency admitted that its review process for Menaflex had been influenced by lawmakers. The agency has also announced that it will now review the approval of the knee device.

Menaflex is manufactured by ReGen Biologics Inc. The approval for the knee device was given against recommendations by agency scientists. FDA staff members have complained that ReGen placed pressure on the agency to approve the device quickly. That allegation had resulted in a furor. Lawmakers raised the issue and Senator Chuck Grassley of Iowa sent letters to the FDA and ReGen Biologics, asking them about their relationship with each other. Email correspondence between ReGen Biologics and agency employees had suggested that the FDA was overly enthusiastic in its willingness to approve Menaflex quickly.

Ultimately, Menaflex was approved under the FDA's fast track policies. Under these rules, medical devices that are somewhat similar to existing medical devices can be approved without the need for clinical trials. There has been very little information forthcoming from the FDA about how Menaflex was approved under these rules, since there were no other devices like it in the market at the time. Thirty patients in the US have been fitted with the device.

According to the New York Times, scientific reviewers at the agency had several times expressed their doubts about the safety of Menaflex. The device apparently failed often, but the agency received, what its reports describes, as "extreme" and "unusual" pressure from four Democratic lawmakers from New Jersey. These lawmakers included New Jersey Senators Frank Lautenberg and Robert Menendez and Representatives Steven Rothman and Frank Pallone Jr. The FDA's former commissioner Andrew C. von Eschenbach insists that he acted properly.

Now, the FDA has agreed with concerns of lawmakers, including Senator Grassley, that the decision to approve Menaflex last year, was flawed. On Thursday, the Food and Drug Administration announced in a report that there had been several "departures from processes, procedures and practices" in the approval process. There was a failure to properly document why Menaflex was approved with the speed it was. The agency has also announced its decision to revisit the review decision. Menaflex will continue to remain on the market while the FDA conducts its review.

The FDA's admission that the review process for Menaflex was flawed is very important because it's the first time the agency has actually admitted flaws in the integrity of its approval process. Besides, the FDA has never before admitted that approval decisions had been influenced by politicians. Meanwhile, patients who have already been fitted with the knee device have been advised not to panic. Dr. Joshua Sharfstein, the FDA's principal deputy commissioner has urged patients to wait for the FDA review of the approval process.

California pharmaceutical liability lawyers will be hoping that this review of Menfalex's approval will help hasten the kind of changes many have been hoping to see at the FDA.