Former U.S. Food & Drug Administration (FDA) Commissioner, Andrew von Eschenbach, has been accused of using his Commissioner status to get a sketchy medical device approved. The situation, which involved lobbyists and members of Congress, seems more akin to a movie than to actual life – yet, many consumer advocate groups say that these types of relationships are all too common.

Money, politics & cozy relationships

According to an article in the Washington Post, Hackensack New Jersey based ReGen Biologics used two heavy hitting lobbyists with cozy ties to members of Congress to get a controversial knee surgery medical device, known as the Menaflex, approved by the FDA. Although the device failed to receive approval three times previously due to the FDA's concerns that it was not effective and may have actually been harmful to users, ReGen's lobbyists and the company's own personal relationship with then FDA Commissioner Andrew von Eschenbach, seemed to make all the difference.

In fact, the Post says that an internal FDA investigation found that, not only did von Eschenbach order an expedited review of the product, he also personally met with members of a New Jersey congressional delegation several times about the product and that FDA staff described the congressional involvement in the matter as “highly unusual.”

The device was approved over staff objections in December of 2008 – very shortly before von Eschenbach's position ended with the Bush Administration.

Mere coincidence?

Were these relationships merely coincidence? The Post suggests they were not – and here is where the money part comes in. ReGen hired two lobbyists in order to get the Menaflex approved. The first was Mike Hutton, a ReGen lobbyist and a former chief of staff for New Jersey Senator Robert Menendez who urged the FDA to approve the Menaflex device.

Hutton was paid nearly $150,000 as a lobbyist for ReGen and contributed nearly $40,000 in campaign finance money to Menendez and three other New Jersey other Democrats – Sen. Frank Lautenberg and Reps. Steven R. Rothman and Frank Pallone Jr. The second was Mark Heller, who – perhaps coincidentally – had previously worked as the FDA's associate chief counsel for medical devices.

Now that von Eschenbach is no longer the FDA Commissioner, the Administration is now reviewing Menaflex's approval.

Consumer advocate groups say that this type of activity may be a bit too common – and that the consumers who end up injured by these defective and dangerous products that often end up as medical device recalls are the ones who really suffer. Congress seems to feel the same way and has ordered a review of the FDA's approval process.