The New York Times reported September 24, 2009 that the Food and Drug Administration (FDA) admitted “that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.” [Blogger's note: all emphasized text throughout this post is mine.]
This admission by the FDA may shock some, but it will come as no surprise to lawyers for consumers who were killed or injured by dangerous drugs and medical devices approved by the FDA under the previous administration. To lawyers engaged in the heated drug and medical-device litigation, it became obvious that some business men and women were willing to sit in their offices and boardrooms and take actions that would kill and permanently injure people. The motive was greed, and the perpetrators were secure in their knowledge that, if the litigation went awry, the damages would be paid from the profits of the shareholders. There was little or no personal responsibility for the decision-makers. Sadly, some executives inside Big Pharma are still enjoying high compensation and fancy corporate perks after killing and injuring hundreds. Contrast that with the day-to-day existence of someone serving prison time for killing or injuring just one person during a robbery, and it becomes clear why some became so outraged at the FDA under the previous administration.
The New York Times article goes on to report:
The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.
But after 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.
The New York Times later wrote an editorial about the corrupting effect of lobbying and political contributions on patient safety, concluding:
This shabby episode carries an important warning for policy makers as they debate health care reform. Decisions on what treatments work best have to be insulated from political lobbying. Otherwise there will be little hope for reining in spending on unproven treatments that may be ineffective or harmful.
Later the business press began to describe the story. An Oct. 8, 2009 Wall Street Journal article discussed the effect of the FDA’s potentialy more stringent approval process on various medical-device manufacturers. And, surprise, surprise, a securities analyst voiced the opinion that he is “‘very much concerned’ about tighter regulations that could slow the pace of innovation.” Even the pro-business Journal immediately followed that quote with this observation: “Device companies commonly rely on upgraded products cleared through 510(k) [the "fast-track approval process] that can fetch higher prices from hospitals.”
My thoughts after reading this disgusting saga:
- Some people in a few big drug and medical-device companies really will kill you for your money, as some consumer attorneys have claimed for years.
- Patients are safer under the current FDA Commissioner, but the bad guys are still out there, and they won’t quit trying simply because it’s gotten tougher.
- Just because four congressmen from New Jersey wear the label “Democrat,” don’t expect them to protect consumers when business lobbyists are throwing money at them. There are a few Republicans (Charles Grassley comes to mind) who seem to care more about patient safety and what’s going on at the FDA than the four guys from Jersey who ReGen’s money and pressured the FDA to approve an unsafe knee patch. This isn’t a defense of Republicans; it’s more of an indictment of the current political and regulatory system, and my belief that a politician’s personal integrity and stand on the issues is more important than party labels.
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