You know all those "frivolous" lawsuits Bush keeps talking about? Apparently, the FDA thinks Bush was talking about those pesky consumers that keep getting injured by big pharma's drugs. These must be the people that are filing all of those "frivolous" lawsuits. To resolve this the FDA will just remove our rights to be able to hold pharmaceutical companies accountable for their greed.
How is the FDA able to remove our rights?
It's called FDA preemption. What is FDA preemption.....?
Basically it means that consumers that are injured by a bad drug or a defective medical device no longer have a right to a trial by jury. In fact they have no recourse at all. The argument that the White House is making (and don't kid yourself, this comes directly from the White House) is that the FDA approves a drug or medical device and if that drug or medical device is defective it is the fault of the FDA not big pharma.
Who benefits from this? Obviously somebody like Merck would be happy if they didn't have to pay 5Billiondollars to the people that were injured by their drug. Medtronic would save hundreds of millions of dollars if they didn't have to pay people that were injured or died from their defective pacemakers and pacemaker wires. Who else you ask? Don't forget that anytime one of these drug companies settles a claim like this the money comes largely from their insurance carriers.
Insurance carriers and big pharma, I would have to guess that those are two of the biggest lobbying industries on K street. Is it time to pay back those contributors? I'm not sure why this is happening all I can tell you is that it is happening.
Last week the FDA sent out a memostating that they were changing the way the FDA updates label changes. This is where you usually find the warning for the drugs and also how the Doctors evaluate how a drug should be prescribed. The FDA is now solely responsible for updating labels and warnings. Previously manufacturing companies could notify they FDA about new dangers associated with their product.
A handful of our representatives did respond in a scathing letter sent to FDA Commissioner Dr Andrew von Eschenbach by eight Congressional Democrats, including committee chairmen Henry Waxman, Edward Kennedy and John Dingell.
"At a time when the FDA lacks the resources to adequately protect Americans from unsafe drugs and devices, it is astonishing that the Bush Administration has opted to dedicate FDA's strained resources to protecting the drug and device industry from liability for marketing dangerous products," it states.
"The 26-page CBE proposal has no purpose other than to shore up the industry's legal arguments for avoiding liability.
If you think that this doesn't apply to you, think again. How many people do you know on an anti depressant? How many people do you know on a cholesterol drug? How about birth control? I can tell you that there are bad drugs everywhere. Many drug companies settle the cases out of court and there are no public records of them. I'm not just talking about a handful of lawsuits, I'm talking about thousands.
I will post a follow up to this diary, but I'll end this one with a personal exerience. In 2003 I contacted my local FDA office and notified the local official that I had 25,000 adverse reactions that I would like to forward to their office. The response I received floored me. They told me to send the reports to the manufacturers and those manufacturers would then submit the reports to the FDA. It seems apparent to me that the fox is guarding the henhouse.
I would love to have some action item for you, but I'm not sure what the best course of action would be at this point. I anxiously await your recommendations.