Lawmakers Pushed FDA To Approve Device


The New York Times reports on a really ugly confluence of politics and campaign contributions. Four New Jersey lawmakers pressured the Federal Drug Administration to approve a medical device after receiving campaign contributions from the New Jersey-based device manufacturer. This was after F.D.A. reviewers ruled that the device “was unsafe because the device often failed, forcing patients to get another operation.”

[A]fter receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money.

Now one could argue that the lawmakers were simply standing up for a local business. Constituent service is constituent service even when the service is for a business. However, the device had not been approved for years because it was found to be ineffective. Lawmakers should be standing up for a sensible approval process for medical devices, rather than standing up for companies that make defective products while providing campaign contributions.

Another thing that may have helped ReGen, one of their lobbyists, Michael Hutton, is the former chief of staff to Sen. Robert Menendez.