Lawmakers Pushed FDA To Approve Device

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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.

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  • John Thacker

    Lawmakers should be standing up for a sensible approval process for medical devices

    Agreed. Just consider that the FDA kills more people than it saves according to every academic study of the subject.

    It applies to medical devices as well. The EU actually has an easier third-party certification for medical devices than the USA. The FDA’s approval process not only makes our medical costs much higher, it costs lives on net. Someone who is killed by a drug makes the news; people who would have been saved if a drug were approved, or if an off-label use were publicized, or if the approval process was easier so that it was worth it to go through it don’t. They’re the invisible victims.

    The FDA should focus on safety (and this device appeared to be unsafe), not effectiveness. It may sound horrible to you, but the science is against you.

    • Not sure what science is against me. I was simply stating that lawmakers shouldn’t be meddling in an independent agency’s approval process at the behest of local interests who provide large campaign contributions and employ their former chiefs of staff. I’m not taking a position aside from that. I have no idea where you read that in this post.

  • Ann

    What exactly is the device?