FDA Succumbs to Pressure to Approve Knee Patch

This week the Food and Drug Administration admitted that the former commissioner of the FDA along with four congressmen from New Jersey influenced their decision to approve a patch that is used for knee injuries. The FDA has since had second thoughts about the process as well as the approval.

For several years the knee patch, manufactured by ReGen Biologics, Inc. was not safe and to top things off it wasn’t effective. The patch, called Menaflex failed to do what it was supposed to and as a result patients who used it ended up having to have their knee operated on.

The New Jersey officials who provided extreme and persistent pressure to have the Menaflex approved are Senator Frank R. Lautenberg, Senator Robert Menendez and Representatives Steven R. Rothman and Frank Pallone, Jr. The former FDA commissioner who was also responsible for the approval was Dr. Andrew C. von Eschenbach. All five claim to have acted appropriately and deny any wrongdoing.

Coincidentally, ReGen Biologics is based in New Jersey and all four legislators were the recipients of generous campaign contributions from ReGen. The FDA has never admitted an error in their approvals nor have they ever called out one of their own.

If you are a recipient of the Menaflex, the deputy commissioner of the FDA wants you to wait until the dust settles to determine the right course of action. Meanwhile, the chairman and CEO of ReGen claims that there is nothing for the 30 patients in the US and 3,000 patients in Europe to do as the claims are inaccurate.

The $3,000 device consists of a pad in the shape of a “C” and it is used to repair a damaged or torn meniscus which is the cushioning in and around the kneecap area. The reason that the Menaflex was approved so quickly was it was determined to be similar to another product that had already been approved.

Earlier this year the Government Accountability Office decided that manufacturers must prove that “all complex devices are safe and effective before being approved for sale.” Wasn’t this a policy that should have been in place from the start?

Even though the four Congressmen received around $26,000 from ReGen they all claim that they did nothing inappropriate and were actually doing their jobs and just trying to help a local company.

And the good Dr. von Eschenbach believes that he oversaw the process and ensured that it proceeded in an “orderly and appropriate fashion.” One person who was surprised by the Menaflex approval was Dr. David R. Schmidt who is the knee surgeon for the San Antonio Spurs. He had been involved in ReGen’s clinical trials of the device and was already aware that it did not work.

Earlier this week the Institute of Medicine was asked by the FDA to review the way that approvals of medical devices are handled. Confusion over reviews and unresolved differences from reviewers has made medical device approvals questionable in the past several years.